(76 days)
The Polaris WR is intended for non invasive wrinkle treatment.
The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.
The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR 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 heat the skin without damaging the epidermis layer.
The provided 510(k) summary for the Syneron Medical Ltd. Polaris WR / ST Applicator does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria.
The document is a Special 510(k) submission, indicating modifications to an already cleared device (Polaris WR). The focus is on demonstrating substantial equivalence to the predicate device, specifically regarding a change in the output wavelength spectrum.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics derived from a study are mentioned.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned.
- 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 MRMC or AI-assisted study is described as this is a device for wrinkle treatment, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical treatment device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
- The sample size for the training set: Not applicable as it's a physical treatment device.
- How the ground truth for the training set was established: Not applicable.
The document primarily states that:
- The device is intended for non-invasive wrinkle treatment.
- The modification involves changing the output wavelength spectrum from 780-980 nm to 700-2000 nm.
- These modifications "raise no new issues of safety or effectiveness."
This suggests that the justification for substantial equivalence relies on the nature of the modification being minor and not altering the fundamental scientific technology or intended use, rather than presenting a new clinical study with specific acceptance criteria.
§ 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.