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Cynosure Cellulaze™ Laser is intended for the improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation).

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The provided document is a 510(k) clearance letter from the FDA for the Cynosure Cellulaze™ Laser. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for the "improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation)".

Without the actual 510(k) submission or a summary of safety and effectiveness, it's impossible to extract the specific data requested in the prompt. Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or comparative effectiveness studies.

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The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.

The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.

Here's a breakdown of the acceptance criteria and study information for the Cynosure Cellulaze Laser, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 57 subjects.
   • Data Provenance: Not explicitly stated (e.g., country of origin). However, it was a "clinical study" that enrolled subjects, implying a prospective and controlled environment.

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

   • Number of Experts: 3 blinded evaluators were used for Endpoint 1 (identification of baseline photographs) and Endpoint 2 (improvement in cellulite appearance).
   • Qualifications of Experts: Not specified. They are referred to as "blinded evaluators."

3. Adjudication method for the test set:

   • The text describes "3 evaluators" for Endpoint 1, with a "range for the 3 evaluators" provided. This suggests independent evaluation by each expert, and their individual results were reported. There is no explicit mention of an adjudication method (like 2+1 or 3+1) to reach a consensus if disagreements arose. It appears each expert's performance was noted.

4. 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study assesses the device's standalone performance in improving the appearance of cellulite, not its role as an AI assistant to human readers.

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

   • Yes, this study represents a standalone performance evaluation of the Cynosure Cellulaze Laser. The "blinded evaluators" are assessing the effect of the device on subjects, not the performance of an algorithm. However, the device itself (the laser system) is performing the intervention, with human evaluators assessing the outcome of that intervention. If we interpret "standalone" as the device's efficacy without human intervention in the therapeutic process, then yes. If it refers to an AI algorithm, then no, this is a physical device study.

6. The type of ground truth used:

   • The ground truth for Efficacy Endpoint 1 (identification of baseline photographs) is directly tied to the actual baseline photographs. The evaluators' task was to correctly identify these.
   • The ground truth for Efficacy Endpoint 2 (improvement in cellulite appearance) was based on expert evaluation/consensus using a "validated scale." The "pre-specified improvement on a validated scale" by blinded evaluators served as the ground truth for success in this endpoint.

7. The sample size for the training set:

   • The provided text does not mention a "training set" in the context of an algorithm. The 57 subjects are part of the clinical study to support the efficacy of the device performing the intervention.

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

   • Not applicable, as no training set for an algorithm is mentioned. The study is a clinical trial evaluating a physical medical device.

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