(69 days)
In addition to already cleared indications, the intended use of the CoolTouch CTEV and CT3S Nd:YAG Laser Systems is: for treatment of reflux of the small saphenous vein 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 three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.
The provided 510(k) summary for the CoolTouch Incorporated Model CTEV and CT3S Nd:YAG Laser Systems describes the device and its intended use, but it does not provide explicit acceptance criteria for a clinical study with specific quantitative metrics. It states broadly that "Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities."
Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance with numerical values, nor can I provide detailed information about the study design elements you requested (sample size, data provenance, ground truth details, etc.). The summary is very high-level regarding the clinical data.
Here's what can be extracted and what is missing, based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured & desired outcome) | Reported Device Performance (What was observed) |
|---|---|
| Explicit acceptance criteria are not stated in the provided text. The document only broadly states "effectiveness" in treatment. | Clinical results "indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities." (No specific metrics or success rates are provided in this summary) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Clinical results were submitted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe how "effectiveness" was measured or adjudicated.
4. Adjudication method 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:
- This device is a laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable to this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device (laser system) for treatment, not an algorithm.
7. The type of ground truth used:
- The document implies that the ground truth was related to the "treatment of reflux of the small saphenous vein associated with varicose veins and varicosities," and its "effectiveness." However, the specific methodology for establishing this ground truth (e.g., direct observation, post-operative imaging, patient outcomes, expert consensus on clinical signs) is not described.
8. The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary is a regulatory filing that confirms substantial equivalence for a medical device (laser system). It does not contain the detailed clinical study information (like specific acceptance criteria, sample sizes, ground truth methodologies, or reader studies) that would typically be found in a clinical trial report or a summary for an AI/diagnostic device.
§ 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.