(90 days)
The Onycho Laser V 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 Onycho Laser V' is a compact device that is positioned on the floor and is operated via a 7.0 inch TFT touch screen for ease of use. The device incorporates lasers and outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect.
The provided text is a 510(k) premarket notification for the Onycho Laser V, a device used for the temporary increase of clear nail in patients with onychomycosis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., x% accuracy, y sensitivity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AF Laser, K221363) through technological comparison and adherence to recognized standards. The "performance" in this context refers to the device meeting these standards and having similar technological characteristics and indications for use as the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Onycho Laser V) |
|---|---|
| Identical Indications for Use | "The 'Onycho Laser V' 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.)." - Identical to Predicate. |
| Identical Laser Wavelength | 405nm/635nm (±10%) - Identical to Predicate. |
| Identical Output Energy | 405nm: 23mW ± 1.85mW; 635nm: 17mW ± 1.35mW - Identical to Predicate. |
| Similar Output Area | "Line pattern electronically scanned over area of treatment" - Similar to Predicate ("Both devices scan the output beams over the areas being treated."). |
| Identical Output Type | Constant Wave - Identical to Predicate. |
| Similar Operating Time | 0-12 minutes with 1-minute increment - Identical to Predicate (Predicate: 0-12 minutes (±5%) with 1-minute increment). |
| Conformity to Electrical Safety Standards | Conforms to IEC 60601-1 (medical electrical equipment basic safety and essential performance). |
| Conformity to Electromagnetic Compatibility Standards | Conforms to IEC 60601-1-2 (electromagnetic disturbances). |
| Conformity to Laser Safety Standards | Conforms to IEC 60601-2-22 (particular requirements for surgical/therapeutic laser equipment) and IEC 60825-1 (safety of laser products). |
| Conformity to Biocompatibility Standards (for device components with patient contact, if any) | Conforms to ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation). |
| Software Validation | "Software was designed and developed according to a software development process and was verified and validated." |
| No new questions of safety or effectiveness | "The technological parameters of the Onycho Laser V device are either identical or similar to those of the predicate device, and the differences do not raise new types of questions regarding the safety and effectiveness for the proposed indications for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a test set involving human subjects for assessing the device's efficacy in treating onychomycosis. The demonstration of substantial equivalence relies on non-clinical testing (electrical safety, EMC, laser safety, biocompatibility, software validation) and comparison to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study with a test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication is described.
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. The device is a laser for direct treatment of onychomycosis, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical laser device, not an algorithm, and its performance is evaluated through non-clinical testing and comparison to the predicate's established safety and effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the requirements of the international consensus standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. Passing these tests demonstrates conformity to the established safety and performance benchmarks within those specific domains. For the claim of efficacy, it relies on the "ground truth" established by the predicate device's prior clearance for the same indication.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
§ 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.