(72 days)
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
The VARI-LASE procedure kit contains a 600µm fiber and the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150 cm) 5Fr/25. 45, or 55 cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture kit
The provided text is a 510(k) summary for the Vari-Lase Endovenous Laser Procedure Kit. It describes the device, its intended use, and the conclusion that it is substantially equivalent to a predicate device. However, it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics.
Therefore, I cannot populate most of the requested fields. The document primarily focuses on regulatory submission and substantial equivalence rather than detailed performance testing.
Here's what I can extract and what remains unknown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states, "Testing has been conducted to verify the biocompatibility and performance of the fiber." However, it does not detail what those performance criteria were, how performance was measured, or the results of those tests. It concludes "substantial equivalence" based on indications for use and components, not specific performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified
- Data Provenance: Not specified (No details provided about the nature or origin of the "testing" mentioned).
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)
- Number of Experts: Not specified
- Qualifications of Experts: Not specified
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified
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
- MRMC Study: No
- Effect Size: Not applicable (No MRMC study mentioned, and the device is a laser procedure kit, not an AI diagnostic tool for human readers).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable (The device is a physical medical instrument, not an algorithm, so "standalone" performance in the context of AI does not apply). The "performance of the fiber" mentioned likely refers to physical properties tested in a lab, not an algorithmic standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified (since performance criteria and actual test results are not detailed).
8. The sample size for the training set
- Sample Size (Training Set): Not applicable / Not specified (No "training set" in the context of an algorithm is discussed for this physical device).
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable / Not specified.
§ 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.