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The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.

The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.

The provided document is a 510(k) summary for the Tria Sapphire device, a blue light therapy system intended for the treatment of mild to moderate inflammatory acne. It focuses on demonstrating substantial equivalence to a predicate device (Tria Beauty, Inc., ATS-1 OTC, K090312).

However, the document does not contain the detailed information required to answer your specific questions about:

• Acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, accuracy, or reduction in acne lesions)
• Sample sizes for a test set for clinical performance
• Number/qualifications of experts for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used for clinical efficacy
• Sample size for training set (of an AI/ML algorithm)
• Ground truth establishment for the training set

The document primarily discusses:

• Non-Clinical Performance: Testing for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation. These are about device function and safety, not clinical efficacy performance against a specific metric.
• Clinical Performance (Usability Study): It mentions a "60-subject, all-comers OTC usability study."
  • Purpose: To demonstrate that subjects could self-select correctly, use the device properly, and comprehend labeling.
  • Outcome: "No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance."

This "clinical" study is a usability study, not a clinical efficacy study designed to prove a certain level of performance (e.g., a specific percentage reduction in acne lesions or accuracy in diagnosis). The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate device, and the usability study was likely used to show that despite being a new device, it could be safely and effectively used by the target OTC population, similar to the predicate.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions related to AI/ML device performance, clinical efficacy metrics, or ground truth establishment for such metrics.

The device outlined in this 510(k) is a light therapy system, and the "performance data" discussed is primarily related to safety, engineering specifications, and usability, rather than the kind of clinical performance data one would expect for an AI/ML-driven diagnostic device (e.g., sensitivity, specificity, AUC, etc., against a gold standard).

If this was an AI/ML device, the detailed information you're asking for would be crucial and would typically be found in a separate clinical study report or a more extensive performance section of the 510(k) submission, which is not present in this summary.

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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

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.

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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

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."

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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.

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.

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The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.

The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

The key points from the document regarding performance are:

• Claim of Substantial Equivalence: TRIA Beauty claims that the ATS-1 OTC's performance data is substantially equivalent to predicate devices, especially their previously cleared ATS-1 (K060567).
• Performance and Consumer Usability Data: The submission states that "Performance and consumer usability data is submitted with this 510(k) notification." However, the details of this data, including specific metrics, sample sizes, or study methodologies, are not present in the provided excerpt.
• No New Questions of Safety or Efficacy: The document states that "performance and consumer usability data demonstrates that any technological differences or changes in labeling do not raise new questions of safety or efficacy or alter the device's intended therapeutic effect in comparison to the predicates." This implies that the current device performs comparably to the predicates and does not introduce new risks or reduce effectiveness.

Given the information, a table of acceptance criteria and reported performance cannot be generated as those details are not explicitly provided. Similarly, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth methodologies for any explicit performance study are not detailed.

The document primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting a new study to meet specific, quantifiable acceptance criteria, the manufacturer aims to show that their new device is as safe and effective as a device already on the market.

Based on the provided text, the specific information requested in your prompt cannot be fully provided because the document focuses on demonstrating substantial equivalence rather than detailing a specific de novo performance study with explicit acceptance criteria.

The lack of this information is typical for devices seeking 510(k) clearance based on substantial equivalence, especially when the device is an iteration of an already cleared product from the same manufacturer. The FDA's 510(k) process often relies on comparative data and pre-existing knowledge about the safety and effectiveness of predicate devices, rather than requiring extensive new clinical trials with predefined performance metrics for every submission.

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