(108 days)
The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Diode Laser Therapy System, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, such as arm, chest, leg, underarm etc.
The provided text is a 510(k) summary for a medical device called "Diode Laser Therapy Systems," which is intended for hair reduction. It details the device, its indications for use, and a comparison to predicate and reference devices.
However, the document does not contain information about acceptance criteria, the study design, ground truth establishment, or performance metrics typically associated with proving a device meets acceptance criteria through clinical or standalone studies for an AI/algorithm-based medical device.
Specifically, the document states: "No clinical study is included in this submission." This means there is no clinical performance data for this specific device in this submission to draw from to describe acceptance criteria or study results as requested in the prompt. The "study" mentioned in the prompt refers to a performance evaluation (often a clinical trial or a robust standalone study for AI devices).
The comparison table (Table 1: Comparison of Technology Characteristics) on page 6 primarily focuses on technical specifications (e.g., laser wavelength, spot size, fluence, electrical safety) and regulatory compliance with standards like ISO and IEC, rather than clinical performance metrics or AI algorithm performance.
Therefore, I cannot fulfill most of the request based on the provided text, as the information regarding clinical performance studies, acceptance criteria for such studies, and all related details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present.
The document concludes that the device is "Substantially Equivalent (SE)" based on non-clinical tests and technological comparisons to predicate devices, not on the basis of a clinical performance study with defined acceptance criteria and tested results.
To answer your request based on the provided text, I must state that the information is absent.
§ 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.