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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.

TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, it focuses on demonstrating safety and efficacy for its intended use. The performance is described in terms of achieving "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth."

However, based on the narrative, the implicit acceptance criteria are that the device effectively performs these functions, and the reported performance indicates that this was demonstrated through clinical trials.

The specific "acceptance criteria" are not detailed in a quantitative manner but are centered around the clinical outcomes of hair removal and permanent reduction in hair regrowth.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that "Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications. Given the nature of the device (hair removal), ground truth might have been established through objective measurements (e.g., hair count, photographic evaluation) and/or patient self-assessment, rather than solely by expert consensus in the traditional sense of diagnostic imaging.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI assistance. This is expected given that the TRIA device is a consumer- direct treatment device, not an AI diagnostic tool.

6. Standalone Performance Study:

The document describes "Clinical trials" that "demonstrate the safety and efficacy of TRIA." This implies a standalone performance study of the device itself (algorithm only, in the context of the device's function) without human adjudication in the loop during the treatment phase. The trials focused on the device's direct effect on hair reduction.

7. Type of Ground Truth Used:

The document states that clinical trials demonstrated "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth." While not explicitly defined, the ground truth would likely involve:

• Objective Measurements: Such as hair count comparisons before and after treatment, potentially using standardized photography.
• Patient Diaries/Self-Assessment: To track sustained hair removal and satisfaction.
• Clinical Assessments by Investigators: Assessing the visible reduction in hair.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is consistent with the device being a laser hair removal system, where "training a model" in the AI sense is not applicable. The development would involve engineering and physical testing, followed by clinical trials to validate the device's performance, not the feeding of data into an AI algorithm for learning.

9. How Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" in the context of an AI algorithm, the question of how its ground truth was established is not applicable. The "ground truth" in the development of the TRIA device would relate to the physical and biological principles of laser hair removal, established through scientific understanding and prior research, rather than a data-driven training process.

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The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.

The provided text is a 510(k) summary for the Spectra Hair Removal Laser System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections (e.g., specific acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment methods, MRMC studies) are not available in the provided document.

However, I can extract what is mentioned about performance and the associated study:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was conducted in a "simulated home-use environment," suggesting a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document does not describe the establishment of a "ground truth" using experts for the purpose of evaluating the device's accuracy in a diagnostic or classification task. The study focused on safety and efficacy for hair removal.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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:

• No MRMC study was done. This device is a hair removal laser, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance. The focus is on the device's direct effect on hair, not an interpretation task.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Yes, in the sense that the device itself is the primary intervention. The performance data relates to the device's direct application in a simulated home-use environment. It's a therapeutic/cosmetic device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For hair removal efficacy, the "ground truth" would implicitly be the reduction in hair growth or hair density observed over time. This would typically be assessed through methods like hair counts, photographic assessment, or patient satisfaction, which fall under outcomes data. However, the specific methodology for establishing this "truth" is not detailed.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that undergoes a training phase with a specific dataset. The "training" for such a device would involve engineering and design iterations, potentially supported by internal testing.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

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The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.

The provided text (K060567) is a 510(k) summary for the SpectraGenics ATS-1, a light therapy device for moderate inflammatory acne vulgaris. However, it does not contain any information regarding acceptance criteria, device performance, or details of a clinical study.

The document primarily focuses on:

• The administrative details of the 510(k) submission (applicant, contact, date, device name, classification, predicate devices).
• A brief description of the device and its intended use.
• A statement that "Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1."
• The FDA's letter of clearance, confirming substantial equivalence to predicate devices, but no specifics about the clinical data itself.
• The "Indications for Use" statement.

Therefore, I cannot provide the requested information. The document merely states that clinical data was provided, but does not summarize or present that data, nor does it detail acceptance criteria or the specifics of a study.

To answer your request, I would need a different document that actually describes the clinical study performed for the SpectraGenics ATS-1, including its methodology, results, and acceptance criteria.

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The Spectra Hair Removal Laser is intended for temporary hair removal.

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

The provided text states, "Performance Data: None. The specifications and indications for use of the Spectra Hair Removal Laser are substantially equivalent to those claimed in the clearance for the above-listed predicate devices. Thus performance data were not required."

Therefore, based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for performance data because it claims substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
4. Adjudication method for the test set: Not applicable. No performance study was conducted.
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 is a laser device, not an AI diagnostic tool, and no performance study was conducted.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used: Not applicable. No performance study was conducted.
8. The sample size for the training set: Not applicable. No performance study was conducted.
9. How the ground truth for the training set was established: Not applicable. No performance study was conducted.

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The Spectra Hair Removal Laser is intended to effect temporary hair removal.

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

Here's an analysis of the provided text regarding the Spectra Hair Removal Laser, focusing on the acceptance criteria and study aspects you requested:

Acceptance Criteria and Study Analysis for Spectra Hair Removal Laser (K032846)

This 510(k) submission explicitly states that no performance data was required or submitted for the Spectra Hair Removal Laser. The basis for clearance was substantial equivalence to legally marketed predicate devices, and the indications for use were a subset of those claimed by the predicates. Therefore, the device did not undergo a specific study to prove it meets acceptance criteria, nor were explicit acceptance criteria defined within this document.

Given this, many of the specific questions about the study design cannot be answered from the provided text.

1. A table of acceptance criteria and the reported device performance

Explanation: The 510(k) states: "None. The specifications and indications for use of the Spectra Hair Removal Laser are a subset of those claimed in one or more of the clearances for the above-listed predicate devices. Thus performance data were not required." This means the device's performance was considered acceptable based on its similarity to already cleared devices, not on specific, pre-defined quantitative criteria.

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 (Test Set): Not applicable, no performance study was conducted.
• Data Provenance: Not applicable, no performance study was conducted.

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)

• Number of Experts: Not applicable, no performance study was conducted.
• Qualifications of Experts: Not applicable, no performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable, no performance study was conducted.

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

• MRMC Study: No. This device is a hair removal laser, not a diagnostic AI system with human-in-the-loop interaction for interpretation tasks.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Study: No. This device is a laser for hair removal, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable, no performance study was conducted. The "ground truth" for this submission was the established safety and effectiveness of its predicate devices for temporary hair removal.

8. The sample size for the training set

• Training Set Sample Size: Not applicable, no AI/ML algorithm was involved, and no performance study was conducted for this specific device.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable.

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