(45 days)
VARI-LASE is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
The VARI-LASE Laser is a semiconducter diode laser operating at 810 ± 20 nanometers.
The provided text describes a 510(k) summary for the Vari-Lase Laser Console. It primarily focuses on the device's characteristics, intended use, and a declaration of substantial equivalence to predicate devices based on non-clinical testing and technology comparison.
Based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, accuracy).
The "Summary of Non-Clinical Testing" section lists various electrical and safety performance standards (EN60601-1, EN60601-1-1, EN60601-2, EN60601-1-4, EN60601-2-22) that the laser console complies with. These are general safety and performance standards for medical electrical equipment, not specific "acceptance criteria" related to a study on the clinical performance of the device's intended use against a defined ground truth.
Therefore, I cannot populate the requested table and information points as they pertain to clinical performance studies. The document only references compliance with general electrical and safety standards.
The document does not contain information on:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics).
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance of an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was 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.