(83 days)
The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of
- · The treatment of vascular lesions, such as angiomas, telangiectasia and other benign vascular lesions.
- Treatment of leg veins.
- · The treatment of benign pigmented lesions.
- · Hair removal and permanent hair reduction.
- · Treatment of pseudofolliculitis barbae.
The Skintel™ Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.
The Palomar Vectus Laser consists of a diode-powered handpiece, Skintel Reader, base module, coolant reservoir, and chiller module. The handpiece connects to the base module via the umbilical.
The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, indications for use, and verification/validation. It includes a general statement about clinical data supporting the Skintel Reader. However, the document does not explicitly detail specific acceptance criteria for the Skintel Reader's performance, nor does it describe a dedicated study designed to prove the device meets established acceptance criteria for its objective measurement of skin melanin content.
Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported performance, or provide detailed information about a study that proves the device meets those criteria.
Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states "clinical data to support the use of the Skintel Reader when used with the Palomar Vectus Laser was also included," but it does not specify what performance metrics (e.g., accuracy, precision) were evaluated against what acceptance thresholds. | Not provided in the document. While clinical data was mentioned as "included," no specific performance values (e.g., specific accuracy percentage, correlation coefficient with a reference method) are reported. |
Missing Information (Not available in the provided text):
Since the document does not describe a study to explicitly prove acceptance criteria, the following information is also not available:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not specified. A multi-reader study is generally not relevant for a melanin reader; this type of study is more applicable for diagnostic AI interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not specified. The Skintel Reader itself is a standalone objective measurement tool, distinct from an "algorithm only" in the sense of a software-based AI interpreting images. Its performance would inherently be "standalone." However, its specific validation is not detailed.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For a melanin reader, ground truth would likely involve a reference spectrophotometer or other validated melanin measurement technique.
- 8. The sample size for the training set: Not specified (if a machine learning model were involved, which isn't explicitly stated for the Skintel Reader).
- 9. How the ground truth for the training set was established: Not specified.
Conclusion based on provided text:
The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader primarily focuses on demonstrating substantial equivalence to predicate devices and states that clinical data for the Skintel™ Reader was included. However, it does not explicitly define acceptance criteria for the Skintel™ Reader's performance, nor does it describe the details of any study that specifically proves the device meets such criteria, as would typically be presented with performance metrics. The information needed to complete the requested table and detailed study description is absent from this document.
§ 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.