(77 days)
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin
The Cheveux Diode Laser System delivers laser light with an 810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.
The Cheneux Diode Laser System's 510(k) summary does not contain the level of detail requested for acceptance criteria and study design. The document is a regulatory submission for substantial equivalence to a predicate device, not a detailed report of clinical performance.
Here's a breakdown of what can be extracted and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given document. The 510(k) summary states, "The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This is a regulatory conclusion, not a presentation of performance data against specific acceptance criteria.
The document lists "Performance Data" but then only states "Results of Clinical Study: The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This confirms the lack of specific performance metrics or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific clinical trial details are given, therefore no sample size for a test set or data provenance (country, retrospective/prospective) can be determined.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. Since no specific clinical trial data or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.
4. Adjudication Method
This information is not provided in the document. No adjudication method is mentioned as there is no detailed description of a clinical study or ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. There is no mention of 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.
6. Standalone (Algorithm Only) Performance
This information is not applicable and not provided. The Cheveux Diode Laser System is a physical medical device (a laser system), not an algorithm or AI system for which "standalone performance" would be relevant in the way you've described.
7. Type of Ground Truth Used
This information is not provided in the document. There is no mention of any ground truth (expert consensus, pathology, outcomes data) being established for a clinical study related to this device.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As above, this is a physical device, not an AI algorithm.
In summary, the provided 510(k) summary for the Cheveux Diode Laser System focuses on demonstrating substantial equivalence to a predicate device (LightSheer Diode Laser System K003614) based on its technological characteristics and intended use. It does not include the detailed performance data, acceptance criteria, or study design information typically found in a clinical trial report for new technology or AI diagnostics. The "Performance Data" section explicitly states the conclusion of substantial equivalence rather than presenting specific quantitative performance results against criteria.
§ 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.