(70 days)
The AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The AF Laser is a medical laser used to treat nail fungus (onychomycosis) and promote the growth of healthy nails. The operating mechanism of this device is photochemical reaction that uses two wavelengths -- 635nm and 405nm. The AF laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive 10.2 inch's wide LCD screen for ease of use. An LCD monitor incorporated into the deck of the device helps the operator check the exact location of treatment area during a procedure.
This document describes the FDA's 510(k) clearance for the AF Laser, a device intended for the temporary increase of clear nail in patients with onychomycosis.
Based on the provided text, the acceptance criteria and study proving the device meets these criteria can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the AF Laser is "substantially equivalent" to its predicate device, the LunulaLaser (K153164). The acceptance criteria appear to be met by demonstrating this substantial equivalence, rather than through specific performance metrics outlined in a dedicated clinical study against a predefined threshold.
| Acceptance Criteria (Implied by Substantial Equivalence Basis) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indications for Use: Must be identical or similarly effective for the intended treatment. | Identical to LunulaLaser: "The AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)." |
| Laser Wavelength: Must be comparable. | Identical to LunulaLaser: 405nm/635nm (±10%) |
| Output Energy: Must be comparable. | Similar to LunulaLaser: |
| AF Laser: 405nm: 23mW ± 1.85mW, 635nm: 17mW ± 1.35mW | |
| LunulaLaser: 405nm: 23.00 ± 2.00mW, 635nm: 17.25 ± 1.25mW | |
| Output Area: Must be comparable. | Identical to LunulaLaser: Line pattern electronically scanned over area of treatment. |
| Output Type: Must be comparable. | Identical to LunulaLaser: Constant Wave |
| Operating Time: Must be comparable. | Identical to LunulaLaser: 0-12 minutes (±5% with 1 minute increment for AF Laser, 0-12 minutes for LunulaLaser). |
| Safety Standards Compliance: Must comply with relevant safety standards. | Passed IEC 60601-1, IEC 60601-1-2, IEC 62471:2006, IEC 60825-1:2014. These are tests for basic safety, essential performance, electromagnetic compatibility, photobiological safety, and laser product safety. |
| General Technological Characteristics: Must be similar. | Similar in Dimension and Weight (minor differences noted). Identical in Screen type (LCD Touch Screen). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document explicitly states: "No Clinical testing was conducted as part of this submission." Therefore, there is no test set of clinical data from human subjects in the traditional sense for evaluating device performance against acceptance criteria for clinical efficacy. The submission relies on a comparison to a predicate device and engineering/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Since no clinical testing was performed, there was no clinical test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
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 for direct treatment, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not a diagnostic algorithm. Performance was assessed through engineering and safety standards compliance, and comparison to the predicate device.
7. The Type of Ground Truth Used:
The "ground truth" for this submission appears to be the established safety and efficacy profile of the legally marketed predicate device (LunulaLaser K153164) and compliance with international safety and performance standards for laser devices.
8. The Sample Size for the Training Set:
Not applicable. As this is not a machine learning or AI device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.