(20 days)
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the hair follicle without damaging the surrounding tissues.
This 510(k) summary describes a Special 510(k) for the Polaris LV / LVA Applicator, which involves an increase in the laser energy density output. The submission explicitly states that the modifications do not affect the intended use or alter the fundamental scientific technology and raise no new issues of safety or effectiveness. As such, the document primarily focuses on the device description and its substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and performance studies (like sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) is not present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics from a study designed to measure the device's efficacy against such criteria for the modified device. The basis for approval is primarily "Predicate Device (PD)" and "Bench Test Data (BTD)".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for this Special 510(k). The regulatory review focuses on the modifications not raising new safety or effectiveness issues. | The device's modified optical fluence (increased from 140 to 350 J/cm²) is considered safe and effective by demonstrating substantial equivalence to predicate devices and through bench testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical test set or study with human subjects for this Special 510(k) submission. The approval is based on "Predicate Device" and "Bench Test Data".
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 applicable, as no clinical test set with ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with adjudication is described.
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 applicable. This device is a laser applicator for treating vascular lesions, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser applicator for treatment, not an algorithm. However, "Bench Test Data (BTD)" was used, which represents standalone testing of the device's physical performance characteristics (e.g., energy output).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical efficacy in this submission. For the bench testing, the "ground truth" would be the device's measured physical parameters (e.g., actual energy output) compared against engineering specifications and predicate device parameters.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.