(173 days)
Tria FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
The provided document outlines the substantial equivalence determination for the Tria FANp device for the treatment of periorbital wrinkles. However, it does not contain the specific acceptance criteria for device performance, nor detailed results of a study designed to explicitly meet such criteria in the format requested. The document describes a safety and effectiveness study, but its focus is on demonstrating substantial equivalence to a predicate device, rather than proving the device meets predefined, quantitative performance acceptance criteria.
Therefore, the following information cannot be fully extracted or is not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not provide a table of performance metrics with specific acceptance thresholds. It states the device was "found to be as safe and effective as the predicate non-ablative fractional device," but doesn't quantify this.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 as this is a medical device (laser), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for the same reason as above.
- The sample size for the training set: Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
Below is an attempt to extract relevant information given the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated) | Reported Device Performance | Comments |
|---|---|---|---|
| Safety | To be as safe as the predicate | Found to be as safe as the predicate non-ablative fractional device | No specific safety endpoints or thresholds are provided. |
| Effectiveness | To be as effective as the predicate | Found to be as effective as the predicate non-ablative fractional device | No specific effectiveness endpoints (e.g., wrinkle reduction percentage, visual scores) or thresholds are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: 45 subjects.
- Data Provenance: The study was a "prospective, open-label safety and effectiveness study" conducted to evaluate the Tria FANp. The country of origin is not specified, but the submission is to the US FDA. Given the context of a 510(k) submission, it is likely the study was conducted in a country with established regulatory pathways for medical devices, potentially the US.
3. 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 document. The document describes a study to evaluate safety and effectiveness but does not specify how "effectiveness" (e.g., wrinkle reduction) was objectively measured or by whom (e.g., blinded expert evaluators, clinical photography with grading scales).
4. Adjudication method for the test set
Not mentioned in the document.
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. The Tria FANp is a physical laser device for treatment, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Tria FANp is a physical laser device for treatment, not an algorithm.
7. The type of ground truth used
The document broadly refers to "safety and effectiveness." For safety, this would likely involve adverse event reporting. For effectiveness, it would typically involve clinical assessment of wrinkle reduction, potentially via standardized photographic scales or expert grading. However, the specific method for establishing "ground truth" (e.g., expert consensus, objective measurement) is not detailed.
8. The sample size for the training set
Not applicable. The Tria FANp is a medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. The Tria FANp is a medical device, not an AI/ML algorithm.
§ 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.