(245 days)
The NIRA Beauty Skincare Laser is indicated for the treatment of periorbital wrinkles.
The NIRA Beauty Skincare Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging).
1. Acceptance Criteria and Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a structured format. However, based on the efficacy section, the key performance indicator and the reported result can be extracted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Significant reduction in periorbital wrinkles (clinical endpoint) | Median reduction of 1 unit in the FWS (Facial Wrinkle Scale) |
| Percentage of subjects showing overall wrinkle improvement | 69% of subjects showed at least one score improvement on overall facial wrinkles assessment |
| Maintenance of wrinkle improvement post-treatment | 68% of users with wrinkle reduction maintained some improvement for at least 3 months after stopping use |
| Safety Profile | No unanticipated or severe adverse events; common adverse events (skin warmth, stinging, dryness, temporary skin color changes) were not unexpected. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: 76 subjects.
- Data Provenance: The study was a "76 subject, open-label comparison to baseline effectiveness, and safety study." While the specific country of origin is not stated, the manufacturer (Dermal Photonics Corporation) is based in Massachusetts, USA, suggesting the study likely took place in the US. The study is prospective as it's a comparison to baseline effectiveness and safety.
3. Number of Experts and Qualifications:
The document does not specify the number of experts used to establish ground truth or their qualifications. The efficacy assessment mentions "median reduction of 1 unit in the FWS" and "overall facial wrinkles assessment," but it's not explicitly stated if this assessment was performed by independent, qualified experts.
4. Adjudication Method:
The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study described is a clinical study on the device's efficacy and safety rather than a comparison of human readers with and without AI assistance.
6. Standalone Performance:
Yes, the study primarily describes the standalone performance of the device (NIRA Beauty Skincare Laser) as used by subjects. The clinical study assessed the device's effectiveness when used by individuals, without explicit mention of human-in-the-loop performance with an AI component.
7. Type of Ground Truth Used:
The ground truth appears to be based on clinical assessment/subjective evaluation of wrinkle reduction, likely by clinicians or trained personnel using a scoring system like the Facial Wrinkle Scale (FWS), combined with subjective reports of safety from the subjects. It is not explicitly stated if objective measures beyond a scoring scale were used.
8. Sample Size for the Training Set:
The document describes a clinical study for the device's efficacy and safety. There is no mention of a separate "training set" in the context of an algorithm or AI model. The 76-subject clinical study serves as the primary data for demonstrating the device's performance for regulatory purposes.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicit mention of a training set for an algorithm, this question is not directly applicable. For the clinical study that serves as performance data, the "ground truth" (i.e., wrinkle reduction and safety outcomes) was established through direct clinical assessments and subject reporting, as described in point 7.
§ 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.