(116 days)
The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) 1-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.
The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. The Sunetics Clinical Laser device provides distributed red laser light dispersing from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength,
The provided text describes the Sunetics Clinical Laser device and its 510(k) submission for market clearance. However, it does not contain information about a study that used a test set, ground truth established by experts, or statistical performance criteria for the device's efficacy in treating hair loss.
The document focuses on the device's technological characteristics, safety testing (electrical, EMC, laser classification), and its substantial equivalence to predicate devices based on these characteristics and intended use. Performance data is mentioned as confirming similar laser wavelength, output power, etc., but this refers to technical specifications, not clinical efficacy metrics.
Therefore, most of the requested information cannot be extracted from this document, as a clinical performance study as described in the prompt was not part of this 510(k) submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Technological Performance | Safe and effective as predicate devices with respect to intended use, technological characteristics, and safety characteristics. | Evaluation of performance data confirms the device has the same or similar laser wavelength, output power, output beam, energy type, laser field, treatment area, and energy delivery as FDA Cleared predicate devices. |
| Electrical Safety | Adherence to LVD electrical safety requirements (IEC 60601-1). | Confirmed adherence to LVD electrical safety requirements. |
| EMC Safety | Adherence to EMC safety requirements (IEC 60601-1-2). | Confirmed adherence to EMC safety requirements. |
| Laser Classification | Certification to laser classification 3R (IEC 60825-1), same as predicate devices. | Certified to laser classification 3R, which is the same as the predicate devices. |
| Design Specifications | Compliance to design specifications; all functions verified to operate as designed. | Met all acceptance criteria in performance testing; all functions were verified to operate as designed. |
2. Sample sized used for the test set and the data provenance:
- Not applicable / Not provided. The submission focuses on device safety and technical equivalence, not a clinical efficacy study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical test set or ground truth on efficacy was established as part of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set.
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:
- No. This document is for a laser therapy device, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided for clinical efficacy. The "performance data" mentioned relates to the device's technical specifications and electrical/laser safety, not clinical outcomes for hair growth. The ground truth for safety aspects would be compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).
8. The sample size for the training set:
- Not applicable / Not provided. This device does not have a "training set" in the context of machine learning or clinical trials.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.