(108 days)
The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device.
Here's an analysis of the provided text regarding the CoolTouch Incorporated Model CTEV Nd:YAG Laser Systems, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific, quantifiable acceptance criteria for the device's performance (e.g., a certain percentage of vein closure, a specific reduction in symptoms). Instead, the assessment focuses on demonstrating the device's effectiveness in treating the indicated conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is effective in the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities. | "Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of vein reflux associated with varicose veins and varicosities." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Clinical results were submitted."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the lack of detail on experts and ground truth establishment, it's highly probable no formal adjudication method like '2+1' or '3+1' was used in the assessment described.
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, this does not appear to be an AI/CAD-based device. The device is a laser system for medical treatment. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device (laser system), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, however, the "clinical results" would likely refer to objective measures of vein closure (e.g., ultrasound findings of successfully treated veins) and/or improvement in patient symptoms, established through clinical follow-up by medical professionals. It's implied this ground truth was based on clinical outcomes as observed by treating physicians, rather than expert consensus on image interpretation or pathology.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable (see point 8).
Summary of Study Details from the Provided Text:
The provided 510(k) summary is very limited in its description of the clinical study. It merely states that "Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of vein reflux associated with varicose veins and varicosities." There is no detailed information about the study design, number of patients, specifics of the outcomes measured, or the methodology used to establish effectiveness. This brevity is common in 510(k) summaries where the device demonstrates substantial equivalence to a predicate, and extensive new clinical trials might not be required if technological characteristics and intended use are similar, and safety/effectiveness can be argued from existing data and principles. The focus here seems to be on a direct clinical outcome (effectiveness in treatment) rather than diagnostic performance metrics.
§ 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.