(150 days)
The PhotoNova Family of Pulsed Light Systems is indicated for the following:
• The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
• The treatment of benign pigmented lesions, including lentigines, nevi, melasma and café-au-lait
• The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
• Treatment of inflammatory acne (acne vulgaris)
The Photonova Pulsed Light Systems delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided document is a 510(k) summary for the PhotoNova Family of Pulsed Light Systems. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not include specific performance data or details about a study designed to prove the device meets acceptance criteria.
The document states: "The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery." This implies that the acceptance criteria are met by demonstrating equivalence to devices already on the market, rather than through novel performance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PhotoNova Family of Pulsed Light Systems. The primary "performance" reported is its substantial equivalence to predicate devices, which implies it performs comparably for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria for this device. Implied acceptance is based on substantial equivalence to predicate devices, meaning it is expected to perform comparably for the given indications. | "The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not available in the provided text.
- Data provenance: Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available in the provided text. The document refers to predicate devices, implying similarity in function and safety, rather than a new study with expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/available as there is no mention of a specific test set or adjudication process for this device's performance.
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 is a pulsed light system, not an AI-assisted diagnostic device. Therefore, an MRMC study with human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (pulsed light system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/available for a new study. The basis for acceptance is substantial equivalence to legally marketed predicate devices. The "ground truth" for the predicate devices would have been established via their own clinical data and regulatory approvals, which are not detailed here.
8. The sample size for the training set:
- Not applicable/available. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/available. As above, this device does not utilize a training set in the AI sense.
§ 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.