(79 days)
Indications for use for PRIMELASE diode laser hair removal system with 755mm, 810mm and 810 - 1060mm applicators include:
· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
• Treatment of Pseudofolliculitis barbae (PFB).
· Use on all skin types (Fitzpatrick I-VI).
PRIMELASE diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin.
The PRIMELASE machine consists of a central unit and a set of 5 removable applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 mm to 1060 nm, typically and most used 810 nm.), pulsed through the laser aperture situated at the tip of the applicator.
The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The treatment can be provided in two modes, dynamic and static. Dynamic mode uses the low fluence & high frequency and is used for initial treatments. Static mode uses high fluence & low frequency and is used for residual hair removal.
The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment
This document is an FDA 510(k) clearance letter and related submission materials for the PRIMELASE diode laser hair removal system. The information provided in it does not describe a study that proves the device meets specific performance acceptance criteria for an AI/ML powered device, especially not those involving diagnostic accuracy or human interpretation. Instead, it demonstrates substantial equivalence to predicate laser hair removal devices based on technical specifications and safety standards.
Therefore, I cannot extract the information required for your request, as the provided text does not contain:
- A table of acceptance criteria and reported device performance (in the context of an AI/ML study).
- Sample size used for a test set or data provenance for an AI/ML study.
- Number of experts used to establish ground truth or their qualifications for an AI/ML study.
- Adjudication method for a test set for an AI/ML study.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML device.
- Information about standalone performance of an algorithm without human-in-the-loop.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
- Sample size for a training set for an AI/ML study.
- How the ground truth for a training set was established for an AI/ML study.
The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 5.7 Clinical Test Conclusion). The "Non-Clinical Test Conclusion" (Page 6, Section 5.6) refers to compliance with general electrical, safety, software, and biological standards (e.g., IEC 60601-1, IEC 62304, ISO 14971, ISO 10993) relevant to medical devices, not performance acceptance criteria for an AI/ML algorithm or its impact on human performance. The "Substantially Equivalence (SE) Comparison" (Page 7) compares technical specifications to predicate devices to demonstrate equivalence for FDA clearance.
§ 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.