(188 days)
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm +/- 20%.
The provided document is a 510(k) summary for the TRIA Laser Hair Removal System. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K090820) rather than presenting a detailed clinical study for a new device with specific acceptance criteria and a new performance study.
Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not explicitly provided in this 510(k) summary. The document states that "Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA for over-the-counter use for hair removal sustained with periodic treatments and for permanent reduction in hair regrowth," but it refers to the previously cleared TRIA as the device used in the clinical study and its performance data for substantial equivalence.
Based on the information available in the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for this specific 510(k submission. It refers to the "permanent reduction in hair regrowth" as its intended effect, defined as "long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen." The performance for this submission is based on the substantial equivalence to the previously cleared TRIA, meaning its performance is considered to meet the same standards.
| Acceptance Criteria (Inferred from Indication) | Reported Device Performance (Inferred from Substantial Equivalence to K090820) |
|---|---|
| Permanent reduction in hair regrowth (long-term, stable reduction in hair counts at 6, 9, and 12 months post-treatment regimen). | Performance is effectively deemed equivalent to the previously cleared TRIA (K090820), which demonstrated this outcome in its clinical trials. |
| Hair removal sustained with periodic treatments. | Performance is effectively deemed equivalent to the previously cleared TRIA (K090820), which demonstrated this outcome in its clinical trials. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary for this submission. The document states, "The TRIA used in the clinical study is the previously cleared TRIA." This implies the clinical data refers to the study performed for K090820, not a new study.
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)
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is 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
This is not applicable. The device is a laser hair removal system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical laser system, not a software algorithm. Its performance is inherent to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For hair removal devices, the clinical ground truth typically involves outcomes data such as direct hair counts, photographic assessment by experts, or patient self-assessment of hair reduction over time. While not explicitly stated here, it would have been established during the clinical trials for the previously cleared TRIA.
8. The sample size for the training set
This information is not provided, as the submission relies on previous clinical trials. The concept of a "training set" in the context of deep learning models is not relevant here; rather, the "training" refers to the clinical trials conducted for the predicate device.
9. How the ground truth for the training set was established
This information is not provided for this submission. For the predicate device's clinical trials, the ground truth would have been established through methodologies typical for dermatological studies focusing on hair reduction, likely involving:
- Hair counting: Expert technicians manually counting hair follicles in a defined area.
- Photography: Standardized photographs evaluated by blinded experts.
- Patient Diaries/Self-assessment: Recording perceived hair reduction.
§ 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.