(245 days)
Tria FAN is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.
The Tria FAN System is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
The provided text describes the Tria FAN System, a diode laser for treating periorbital wrinkles. However, it does not contain detailed acceptance criteria for the device's performance, nor does it provide a specific study with statistical results that prove the device meets such criteria in terms of quantitative metrics (e.g., accuracy, sensitivity, specificity, wrinkle reduction percentage).
The text focuses on demonstrating substantial equivalence to predicate devices based on safety and effectiveness.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: (Implicitly: no new safety concerns compared to predicates) | "The Tria FAN System was found to be as safe...as the predicate non-ablative fractional devices." |
| Effectiveness: (Implicitly: as effective as predicates for periorbital wrinkles) | "The Tria FAN System was found to be as...effective as the predicate non-ablative fractional devices." |
| "indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area." | |
| Substantial Equivalence: (Implicitly: similar intended uses, indications, tech characteristics, and operations) | "The Tria FAN System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." |
| "The minor technological differences...raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 60 subjects
- Data Provenance: Prospective, open-label study. Country of origin not specified, but the applicant is based in Dublin, CA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided. The text only states that the study evaluated safety and effectiveness, but it doesn't describe how "effectiveness" (e.g., wrinkle reduction) was objectively measured or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided.
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 device is a laser system, not an AI or diagnostic imaging device involving "readers" or "AI assistance." The clinical study focused on the device's direct effect on patients.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (laser system), not an algorithm. The clinical study evaluated the device being used by humans.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for effectiveness in the clinical study would likely be based on subjective or objective assessments of wrinkle severity before and after treatment. However, the specific method (e.g., physician global aesthetic improvement scale, profilometry, patient satisfaction) is not detailed in the provided summary. "Smoother appearing skin" is the reported outcome, implying a visual assessment.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of missing information:
The provided 510(k) summary is high-level and lacks detailed information typically found in a clinical study report, especially regarding:
- Specific, quantifiable acceptance criteria for effectiveness (e.g., a specific percentage reduction in wrinkle count or depth, or a percentage of subjects achieving a certain improvement score).
- The methodology for assessing wrinkle improvement (how "smoother appearing skin" was measured and by whom).
- Any statistical results from the 60-subject clinical study (e.g., p-values, confidence intervals, specific improvement scores). It only states the device was "as safe and effective as the predicate."
§ 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.