(81 days)
The CO2 Laser Therapy System is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Therapy System is a carbon dioxide laser used in medical and aesthetic industry. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and and then achieve the indications. The proposed device is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
It appears there might be a misunderstanding regarding your request. The provided document is an FDA 510(k) summary for a CO2 Laser Therapy System, which is a medical device for surgical applications. This document does NOT contain information about an AI/ML-based device or a study involving acceptance criteria for such a device, human readers, ground truth establishment, or training sets.
My analysis of the provided text reveals that the medical device in question is a CO2 Laser Therapy System. This is a physical, hardware-based medical equipment used for tissue vaporization and coagulation. The FDA submission focuses on demonstrating its substantial equivalence to a predicate device, primarily through non-clinical testing against established safety and performance standards for laser equipment.
Therefore, I cannot fulfill your request for information about:
- Acceptance criteria and reported device performance for an AI/ML device: The document describes a physical laser device, not an algorithm.
- Sample size and data provenance for a test set (related to AI/ML): There is no mention of an AI/ML test set. The "test results" refer to engineering and safety tests on the hardware.
- Number of experts and qualifications for ground truth (related to AI/ML): No ground truth establishment for an AI/ML model is discussed.
- Adjudication method (related to AI/ML): Not applicable to this type of device submission.
- Multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance: No AI component is mentioned.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (pathology, outcomes data, etc. for AI/ML): Not applicable.
- Sample size for the training set (for AI/ML): Not applicable.
- How ground truth for the training set was established (for AI/ML): Not applicable.
The document explicitly states in Section 9: "No clinical study is included in this submission." and Section 8, "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
The "acceptance criteria" discussed in this document are primarily related to compliance with international electrical, EMC, and laser safety standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2) which are applied to the physical device. The "performance" refers to the device's physical specifications (e.g., maximum power, wavelength, work mode) and demonstrating they are equivalent to the predicate 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.