(28 days)
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
The, Azuryt Model CTL 1401 CO₂ Surgical Laser System is a CO₂ laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcomputer and control panel.
The provided text describes a Premarket Notification [510(k)] Summary for a CO2 Surgical Laser System. This type of device is classified as a medical electrical equipment, and the document outlines its compliance with safety and performance standards rather than presenting a clinical study with acceptance criteria in the context of diagnostic or AI-driven devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance) are not applicable to this document as it does not describe a study involving human or image data for diagnostic or AI algorithm evaluation.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This device's "performance" is demonstrated by its adherence to established international safety and performance standards for CO2 surgical lasers and its substantial equivalence to predicate devices. The acceptance criteria are essentially the requirements of these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Compliance) |
|---|---|---|
| Safety of Laser Products | EN60825-1 / IEC 60825-1: Equipment classification, requirements and user's guide | Complies |
| Medical Electrical Equipment - Safety Requirements | EN60601-2-22 / IEC 60601-2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment | Complies |
| Medical Electrical Equipment - General Safety Requirements | EN60601-1 / IEC 60601-1 (including amendments): General requirements for safety | Complies |
| Medical Electrical Equipment - Electromagnetic Compatibility | EN60601-1-2 / IEC 60601-1-2: Electromagnetic compatibility - Requirements and tests | Complies |
| European Medical Device Directive | 92/42/EEC | Complies |
| US Federal Performance Standards for Laser Products | 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products (with allowed deviations under Laser Notice No. 50) | Complies |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (Deka Smart CO2 laser, Lumenis LX-20 CO2 Surgical Laser System) in intended use and technological characteristics. | Azuryt Model CTL 1401 has the same intended uses and similar technological characteristics as the predicate devices. The system performs as intended and raises no new safety or effectiveness issues. |
2. Sample size used for the test set and the data provenance
Not applicable. This document refers to compliance testing against engineering and safety standards, not a clinical test set for an AI/diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert ground truth in a clinical context.
4. Adjudication method for the test set
Not applicable.
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 surgical laser system, not an AI-assisted diagnostic or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established requirements and specifications within the cited international and federal standards. Compliance with these standards is determined through engineering tests, quality assurance procedures, and comparison of technological characteristics to already approved predicate devices.
8. The sample size for the training set
Not applicable. This is a hardware medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.