Examining labelling guidelines for AI-based software as a medical device: A review and analysis of dermatology mobile applications in Australia.

In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.

The Utility of Bone Burring for the Clearance of Locally Advanced Scalp Malignancies: A Scoping Review.

The scalp harbors a range of neoplasms occurring at inordinate rates and associated with poorer outcomes. Its unique anatomy poses surgical challenges, including clear deep margins when resecting these lesions. For malignancies extending to the pericranium, removal of outer cortical cranial bone is ideal and routinely achieved with a burr. This review aims to investigate the literature to ascertain the utility and safety of this technique while highlighting evidence gaps. Methods: A literature search was conducted systematically using MEDLINE, Embase, and PubMed. Articles were reviewed for inclusion, and eligible studies were analyzed for study design, patient and intervention details, and outcome measures. A formal statistical analysis was not conducted. Results: The original search yielded 1506 unique results, and eight studies met the inclusion criteria: four case series, two retrospective analysis of records, two case reports. A number of tumor types were identified, but the burring method used was consistent in all studies. Despite reassuring primary outcome measure results, specifically in terms of local control rates, the overall evidence quality is limited by the nature of the included studies. Few adverse events were reported. Conclusions: Evidence for the oncological efficacy of scalp bone burring remains limited. Although the technique seems relatively safe, further investigation is required into its utility and drawbacks. Future studies should aim to report more technical details and more information about outcomes. It may also be worth comparing burring to alternatives such as outer cortical splitting, curettage, and high-dose curative radiotherapy.