(467 days)
The MediYag is indicated for:
532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait).
1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).
The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm.
| Component Name | Function |
|---|---|
| Main Unit | Main human-machine interface |
| Articulated Arm | Articulated arm for holding of Treatment Probe |
| Treatment Probe | Laser Delivery |
| Foot Pedal | Control light output |
The provided document is a 510(k) summary for the MediYag laser surgical instrument. It states that no clinical study was included in this submission (Section 8, page 6). Therefore, there is no information in the document to describe acceptance criteria or a study that proves the device meets such criteria based on clinical performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications.
Here's a breakdown of the requested information based on the provided text, highlighting the absence of clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was performed, there are no acceptance criteria for clinical performance or reported device performance in terms of clinical outcomes. The device performance listed below is based on non-clinical technical specifications outlined for comparison to predicate devices.
| Specification | Acceptance Criteria (Implied by comparison to predicate) | Reported Device Performance (MediYag - K231948) |
|---|---|---|
| Wavelength | 1064 nm and 532 nm | 1064 nm, 532 nm |
| Output Energy (1064 nm) | Within comparable range of predicates | 100-1300 mJ |
| Output Energy (532 nm) | Within comparable range of predicates | 50-450 mJ |
| Maximum Energy Density (1064 nm) | Within comparable range of predicates | 41.4 J/cm² |
| Maximum Energy Density (532 nm) | Within comparable range of predicates | 14.3 J/cm² |
| Spot Size | 2-10 mm | 2-10 mm |
| Pulse Width | 5 ns (comparable to predicate's 5-10 ns) | 5 ns |
| Repetition Rate | 1-10 Hz | 1-10 Hz |
| Safety and Performance Standards | Compliance with IEC 60601-1, IEC 60601-1-2, ISO 14971 | The test results demonstrated that the proposed device complies |
| Software Functionality | Meets design specifications | Verified through interaction and observation methods |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data is provided. Non-clinical testing involved validating design specifications, but a "sample size" in the context of patient data is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set and thus no "ground truth" derived from expert review of patient data is described.
4. Adjudication method for the test set
Not applicable. No clinical test set 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 MediYag is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser surgical instrument, not an algorithm, and intrinsically requires human operation (human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical "ground truth" data is referenced as no clinical study was performed. For non-clinical testing, the "ground truth" would be the device's design specifications and performance parameters, verified through engineering tests.
8. The sample size for the training set
Not applicable. No training set is mentioned as no clinical study or machine learning algorithm development (in the sense of a dataset) is described.
9. How the ground truth for the training set was established
Not applicable. As no training set or clinical study is described, there's no information on how any "ground truth" for a training set would have been established.
§ 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.