(88 days)
The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.
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 the handpiece.
The provided document is a 510(k) summary for the CoolTouch Nd:YAG Laser System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel acceptance criteria. As such, it does not contain the specific information required to complete all sections of your request.
Here's an analysis of the available information:
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Acceptance Criteria and Reported Device Performance: The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it mentions that "Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles." This is a qualitative statement about effectiveness, not a specific performance metric. Since no explicit criteria are provided, a table cannot be constructed.
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Sample size for the test set and data provenance: The document states "Clinical trials produced results...", but it does not specify the sample size for these trials, nor does it mention the country of origin or whether the data was retrospective or prospective. It refers to "previous related 510(k) submissions for clinical results," implying the data was presented elsewhere.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the summary.
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Adjudication method: This information is not provided in the summary.
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Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The device is a laser system, not an AI diagnostic tool.
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Standalone (algorithm only without human-in-the-loop performance) study: This is not applicable as the device is a laser system used by a clinician, not an algorithm.
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Type of ground truth used: Given the indication for "treatment of fine lines and wrinkles," the ground truth likely would have involved expert assessment of wrinkle reduction (e.g., photo-grading scales, patient-reported outcomes), but this is not explicitly stated.
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Sample size for the training set: This is not applicable, as the document describes a medical device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: This is not applicable.
Summary of Available Information from the Provided Text:
| Criteria | Information from Document |
|---|---|
| Acceptance Criteria & Reported Device Performance | No quantitative acceptance criteria are explicitly stated. The document mentions: "Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles." |
| 1. Sample size for test set & Data Provenance | Clinical trials were conducted, but the specific sample size is not mentioned. Data provenance (country, retrospective/prospective) is not specified. The document refers to "previous related 510(k) submissions for clinical results." |
| 2. Number/Qualifications of Experts (Ground Truth - Test Set) | Not provided. |
| 3. Adjudication Method | Not provided. |
| 4. MRMC Comparative Effectiveness Study (AI vs. without AI) | Not applicable. The device is a laser system, not an AI-based diagnostic tool. |
| 5. Standalone Performance Study (Algorithm Only) | Not applicable. The device is a laser system requiring human operation. |
| 6. Type of Ground Truth Used | Likely involved expert assessment of wrinkle severity or reduction, possibly with patient-reported outcomes, but not explicitly stated. |
| 7. Sample Size - Training Set (AI) | Not applicable. The document describes a medical device, not an AI algorithm. |
| 8. Ground Truth Establishment - Training Set (AI) | Not applicable. The document describes a medical device, not an AI algorithm. |
This 510(k) summary primarily serves to establish substantial equivalence with a predicate device (New Star Lasers, Inc. Model 130 Nd: YAG Surgical Laser System K962791) rather than to present detailed results of a clinical study designed to meet specific performance acceptance criteria for a novel technology. The "Nonclinical Performance Data" is stated as "None," and for "Clinical Performance Data," it refers to "previous related 510(k) submissions," indicating that the detailed clinical evidence was likely submitted and reviewed in those prior applications and not reiterated in this summary.
§ 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.