(115 days)
The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
The Clear Bi-Light is a hand-held, light emitting device for treating mild to moderate acne. The Clear Bi-Light is non-prescription and is intended for over-the-counter sale. Each Clear Bi-Light package includes the following:
- One Clear Bi-Light rechargeable handpiece
- Two Treatment Heads
- One blue light (405 - 420 nm)
- One red light (630 660 nm)
- One Charger Stand
- One AC adaptor power cord
- One pair goggles
- The Clear Bi-Light Instruction Manual
I am sorry, but there is no information about acceptance criteria or a study proving device performance, sample sizes for test or training sets, data provenance, expert numbers and qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment within the provided text.
The document is a 510(k) premarket notification summary for a device called "Clear Bi-Light." It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and non-clinical testing (biocompatibility, electrical safety, electromagnetic compatibility, photobiological safety, and software verification).
The document states:
- Device Name: Clear Bi-Light
- Indication for Use: Treatment of mild to moderate inflammatory acne.
- Nonclinical Testing: Biocompatibility, Electrical Safety and Electromagnetic Compatibility, Photobiological Safety, and Software Verification and Validation. These tests confirm the device meets relevant safety standards and its software functions as designed.
- Comparison to Predicate Devices: A detailed table compares the Clear Bi-Light's specifications (indication, energy source, wavelengths, controls, dose rate, temperature, dimensions, etc.) to three predicate devices (Tanda Mini, Silkn Blue, OmniLux Clear U) to argue for substantial equivalence.
However, it does not contain the following information typically found in clinical studies or performance evaluations:
- Acceptance Criteria for Clinical Performance: No specific thresholds for efficacy (e.g., percentage reduction in lesions, success rates) are mentioned.
- Reported Device Performance: There are no clinical outcomes (e.g., actual acne reduction percentages, user satisfaction rates) reported.
- Sample Sizes: No mention of the number of subjects (patients) in any clinical study.
- Data Provenance: No details on country of origin, retrospective/prospective nature of data.
- Ground Truth Establishment: No information on how acne severity was measured or confirmed by experts.
- Expert Qualifications/Adjudication: No details about experts, their number, or how their assessments were reconciled.
- MRMC Study: No mention of human reader studies or improvements in human performance with AI assistance.
- Standalone Performance: No algorithm-only performance metrics are provided, as this is a light-emitting device, not an AI diagnostic algorithm.
- Training Set Details: Since this device is not an AI algorithm, there would be no "training set."
Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses on demonstrating safety and technical equivalence to predicate devices rather than proving clinical efficacy with specific performance metrics from a user-facing study.
§ 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.