(116 days)
The BeMitt™ Self Breast Exam is indicated as an aid for performing breast-self examinations.
The BeMitt™ Self Breast Exam is indicated as an aid for performing breastself examinations. The device is made of conformable polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The document is a 510(k) summary for the BeMitt™ Breast Self Examination Aid, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a specific study.
Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and study details based on the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not found in the document. The document states that the device "meets or exceeds all safety requirements for a device in its regulatory class and is found to be identical in materials and functionality when compared to the stated predicate devices," but no specific performance criteria or metrics are reported.
- 2. Sample size used for the test set and the data provenance: Not found in the document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
- 4. Adjudication method: Not found in the document.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not found in the document. The device is a physical aid for self-examination, not an AI or imaging device, so an MRMC study would be irrelevant.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical self-examination aid.
- 7. The type of ground truth used: Not found in the document.
- 8. The sample size for the training set: Not found in the document.
- 9. How the ground truth for the training set was established: Not found in the document.
The 510(k) submission for BeMitt™ focuses on substantial equivalence to existing devices (My Breast Friend and Sensa Touch Breast Self Exam Glove) based on materials, intended use, and general safety. It does not include a specific clinical performance study with defined acceptance criteria for the new device itself.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.