(173 days)
The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
The CoolTouch NS-160 Nd:YAG Laser System is an ND:YAG laser producing laser emission at 1320 nm. The laser consists of two sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic.
The provided text describes a 510(k) premarket notification for the CoolTouch NS-160 Nd:YAG Laser System. It states that "Clinical data produced results that indicate that the CoolTouch Nd:YAG Laser System is effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities." However, it does not provide specific quantitative acceptance criteria or detailed results to fill out the table requested. It also lacks detailed methodology for the clinical study.
Therefore, many sections of your request cannot be fulfilled from the provided text.
Here's what can be extracted based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified in text | Not specified in text |
| Qualitative Acceptance: Efficacy in treating reflux of greater saphenous vein associated with varicose veins and varicosities. | Reported Performance: Clinical data indicates effectiveness in treating reflux of the greater saphenous vein associated with varicose veins and varicosities. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective). The document only states "Clinical data produced results."
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 specified. The document does not mention the use of experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- Not applicable. This is a laser system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text implies an evaluation of clinical outcomes ("effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities"). However, the precise method of determining "ground truth" or clinical success (e.g., specific imaging follow-up, patient reported outcomes, physician assessment criteria) is not detailed.
8. The sample size for the training set
- Not applicable. This is a medical device (laser system), not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8).
§ 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.