(88 days)
BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.
This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.
The provided document is a 510(k) Summary for a medical device called BC-001+ Acne Purifier. This type of document is for premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on safety and technological equivalence rather than detailed clinical effectiveness studies with specific performance metrics like sensitivity, specificity, or reader studies for AI-powered devices.
Therefore, the information requested, particularly regarding acceptance criteria, reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This is because the device described is a light-emitting device for acne treatment, not an AI-powered diagnostic tool.
The "Performance Data" section (7. PERFORMANCE DATA) in the document refers to a series of tests to demonstrate the device's safety and general performance, not its diagnostic accuracy or effectiveness in comparison to a gold standard as would be done for an AI device.
Here's why each point you requested is not applicable or not found:
- A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI-powered diagnostic device. The performance data listed (biocompatibility, electrical safety, software verification, usability) are safety and engineering performance criteria, not clinical outcome or diagnostic accuracy metrics.
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual device and its components undergoing engineering and safety tests, not a dataset for an AI algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic ground truth being established for an AI algorithm.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to whether it passes safety and engineering standards.
- The sample size for the training set: Not applicable, as this device does not involve an AI algorithm with a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of available information regarding "Performance Data" from the document:
The "PERFORMANCE DATA" section (Section 7) describes the following types of testing done for the BC-001+ Acne Purifier to support its substantial equivalence determination:
- Biocompatibility testing: Conducted according to ISO 10993-1. Tests included cytotoxicity, sensitization, and irritation.
- Electrical safety and electromagnetic compatibility (EMC) testing: Device complied with IEC 60601-1-11, IEC 60601-2-57, IEC 62471 standards for safety, EN 60601-1-2 for EMC, and IEC 62133 for battery safety.
- Software Verification and Validation Testing: Conducted as per FDA guidance for "Moderate" level of concern software.
- Usability Testing: Conducted according to FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design."
These tests confirm the device's safety and functional performance as a light therapy device, not its diagnostic accuracy.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.