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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 Juniper Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort.

The Juniper Cooling Device a thermoelectric cooling device that applies controlled cooling to a treatment site.

The provided text describes a 510(k) summary for the Juniper Cooling Device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a scientific or clinical study.

Instead, the submission establishes substantial equivalence to predicate devices based on:

• Intended Use: The indications for use are the same as predicate devices.
• Technological Comparison: The device is described as a thermoelectric cooling device, similar to the predicates.
• Bench Testing: "Bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices."

Therefore, most of the requested information regarding detailed acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document primarily focuses on demonstrating substantial equivalence to already marketed devices.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

Note: No specific numerical or quantitative acceptance criteria (e.g., cooling temperature range, cooling rate, pain reduction percentage) are provided in this summary. The "performance data" section is very general.

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

Not applicable/Not provided. The submission refers to "bench testing" but does not detail the sample size, specifics of the "test set" (e.g., number of devices tested, number of simulated skin models), or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission focused on substantial equivalence where detailed clinical trial data might not be required if technological equivalence and intended use are sufficient.

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

Not applicable/Not provided. There is no mention of human experts establishing ground truth for any test data in this submission. The evaluation is based on technical comparison and bench testing for functional equivalence.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is described, as there isn't a human expert-based ground truth establishment process detailed.

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/Not provided. This device is a cooling device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human reader performance or AI assistance is not relevant or described.

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

Not applicable/Not provided. The device is a physical cooling device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant. The "performance data" refers to the device's functional equivalence.

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

Not applicable/Not provided. The evaluation appears to be based on the device's functional characteristics observed during "bench testing" compared to predicate devices, rather than a "ground truth" derived from clinical outcomes, pathology, or expert consensus on patient data.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable/Not provided. As it's not an AI/ML algorithm, there is no training set or associated ground truth.

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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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