(364 days)
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
The provided text does NOT contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.
Instead, the document is a 510(k) summary for the Soundskin Phototherapy System, asserting substantial equivalence to a predicate device (Lumenis Clearlight K013623).
Here's what can be extracted based on the prompt's requested information, with significant gaps for the criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Visible Light Source: High spectral purity, uniform illumination. |
| Red Light Output: 635 +/- 5nm wavelength, narrow spectral bandwidth. | |
| Blue Light Output: 435 +/- 5nm bandwidth. | |
| Light Output (Intensity): 2460 mW per sq cm of treatment area. | |
| Lamp Efficiency: 95% of output. | |
| Timer: Electronic timed (mechanical relays), red light for 10 minutes, then blue light for 10 minutes, automatic shut-off after 20 minutes. | |
| Safety/Effectiveness Claim: "no significant differences exist between this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The document states "clinical trials prove the effectiveness is the same," implying clinical data was used, but details on location (country of origin), whether it was retrospective or prospective, or specific data used for this device's pre-market submission versus the predicate's trials are not provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a phototherapy system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a standalone phototherapy system; it does not involve an algorithm separate from human-in-the-loop performance in the sense of a diagnostic or decision-support AI. Its performance is inherent to its physical light emission and timing mechanisms. No separate "algorithm-only" performance study is described beyond its physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that "clinical trials" (likely referencing the predicate device's trials, or trials that directly compare this device to the predicate) were used to demonstrate effectiveness. The ultimate ground truth would likely involve clinical outcomes data related to the reduction of moderate inflammatory Acne Vulgaris.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device.
§ 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.