(23 days)
The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
The Platinum Bright Tip is a laser fiber that is compatible with a solid state diode laser console. The laser fiber is comprised of a platinum/iridium distal tip, a 600 um core laser fiber and an SMA connector. The laser fiber lengths are between 2.4 meters and 3.6 meters, with a maximum diameter of 0.038". The laser fiber is available with or without positioning marks.
The provided text is a 510(k) summary for a medical device (Vari-Lase Platinum Bright Tip laser fiber) and its FDA clearance letter. It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert involvement, MRMC study, standalone performance, training set details) are not applicable or extractable from the provided document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through design verification testing and biomaterial assessments, rather than extensive clinical efficacy studies with the requested level of detail for AI/image analysis.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document describes "biomaterial assessments and other design verification testing," but does not provide specific quantitative acceptance criteria or performance metrics for these tests. The focus is on demonstrating substantial equivalence to the predicate device.
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. No specific test set sample sizes or data provenance are described for clinical performance. The testing mentioned appears to be design and material verification, not clinical studies.
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 type of information is typically relevant for studies involving image analysis or diagnostic performance, which is not the primary focus of this 510(k) for a laser fiber. Ground truth establishment by experts is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical test set requiring expert ground truth or adjudication is described, this is not relevant.
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 fiber for surgical procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical instrument (laser fiber), not an algorithm or AI. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The document does not describe the use of ground truth in the context of clinical studies for performance evaluation. The "ground truth" for this type of device would primarily be its adherence to material specifications and functional performance in in-vitro or simulated use tests, not clinical outcomes data for a "ground truth" comparison.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this device is a physical medical instrument, not an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
§ 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.