(206 days)
The ADVATx at 589nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striea, and psoriasis.
The ADVATx at 1319nm is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris.
The ADVATx Laser System is a Nd:YAG laser delivering 589nm @-switched pulsed light and 1319nm continuous wave light. This laser system was developed specifically for dermatological treatments. The laser light is delivered to the patient either through a scanner or a hand piece.
This document is a 510(k) summary for the AdvaLight ApS ADVATx surgical laser. It describes the device's intended use, technological characteristics, and claims of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with machine learning or diagnostic device studies.
The "Performance Data" section solely mentions electrical and laser safety testing, and general system/software validation, which are compliance checks, not performance studies as requested in the prompt.
Therefore, most of the requested information cannot be extracted from this document because the provided text concerns regulatory approval of a medical laser device, not a study evaluating its diagnostic or AI-driven performance against specific clinical acceptance criteria.
However, I will extract what I can based on the prompt's categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-22. |
| Laser Safety | Complies with IEC 60825-1. |
| System and Software Validation | Performs as intended and meets its specifications. |
| Laser Output Spectrum and Power Stability | Stable over a single treatment session and long term. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes safety and system validation tests, not a clinical performance study with "test sets" in the context of device effectiveness for its intended use or AI algorithms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document does not describe a study involving adjudication of a test set.
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 document does not describe an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document pertains to a physical laser device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the tests mentioned are regulatory standards (e.g., IEC standards for safety), not clinical outcomes or expert consensus on medical conditions.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is mentioned or relevant to the content of this document.
§ 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.