(87 days)
The THERMALIGHT®® 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation).
The Thermalight2000 is an instrument which is designed to painlessly, safely, and effectively remove hair by the application of pulsed light energy to the hair follicle. It operates similar to needle electrolysis machine in that it removes hair, one hair at a time by thermolysis. Using the Thermalight2000, thermolysis is achieved by the application of light energy to the hair growth support tissue instead of the application of electrical energy employed by conventional needle electrolysis units.
The provided text is a 510(k) premarket notification for the THERMALIGHT® 2000 device, an epilator. This type of document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically found in efficacy trials.
Therefore, the requested information regarding acceptance criteria, device performance, study design, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully provided from the given text.
Here's an analysis of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly available in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device (D' Plume XXII Photocoagulator - K895687) rather than meeting specific performance acceptance criteria for a new clinical claim. The "performance" mentioned is primarily about its operational similarity and improved reliability/economy due to modern design, not specific clinical outcomes with predefined thresholds.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified clinical outcome metrics like hair reduction percentage, pain scores, or adverse event rates with specific targets. |
The text states:
- "The THERMALIGHT®® 2000 incorporates more modern design techniques and newer components which provide a more reliable unit, with more economical, and more consistent performance." (This is a general statement, not a quantified performance metric against an acceptance criterion).
- "Unlike the machines which treat large areas at a time, the THERMALIGHT®® 2000 is safe and can not generate enough power to damage the skin. The light energy is applied by means of a optical fiber tip which is placed at the entrance to the hair follicle. The tip never enters below the skin. There is no pain, no skin damage, and there is no risk of introducing disease." (These are safety claims, not quantitative performance data against specific criteria).
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text.
The document does not describe a specific clinical "test set" or a study designed to evaluate the device's efficacy in terms of hair removal. It's a regulatory submission for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/available.
Since no specific test set or clinical study for efficacy is described, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable/available.
No adjudication method is mentioned as there is no described test set or clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available/applicable.
The document is a 510(k) submission, not a report of a clinical efficacy trial, and therefore does not discuss MRMC studies or human reader improvement with AI. The device described is an epilator, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Not directly available in the provided text.
Again, the focus is on substantial equivalence to an existing device, not a standalone performance study in the way one would evaluate an AI algorithm. The closest information is the safety claim that "the THERMALIGHT®® 2000 is safe and can not generate enough power to damage the skin." However, this is not a detailed performance study.
7. Type of Ground Truth Used
Not applicable/available.
There is no described clinical study or ground truth for performance. The "ground truth" for the 510(k) pathway is that the device is "substantially equivalent" to a legally marketed predicate device, relying on design and intended use similarities.
8. Sample Size for the Training Set
Not applicable/available.
This is not an AI/ML device, so there is no concept of a "training set" in the context of the provided document.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available.
As above, this is not an AI/ML 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.