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The Sound Surgical Technologies LLC PowerX Lipo System is intended for the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

The Sound Surgical Technologies LLC (Sound) PowerX Lipo System (PowerX) consists of three major components: (1) an electronic Controller with software, (2) an electronic Handpiece, and (3) a reusable, sterilizable Cannula. The Handpiece is connected to the Controller and to an independent aspiration source. The Controller sends electronic signals to the Handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the Handpiece. The Sound PowerX is a prescription device, and is intended for use by trained medical personnel.

The provided document is a 510(k) summary for the Sound Surgical Technologies LLC PowerX Lipo System. It describes the device, its intended use, and various performance tests conducted to demonstrate its safety and effectiveness. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what such a request implies.

The "Performance Testing" section states that "The Sound PowerX was tested for performance in accordance with its predetermined specifications as specified in Section 11, Device Description - Performance Specifications, of this submission. Test results indicate that the Sound PowerX complies with its predetermined specification." However, Section 11 is not provided in the snippet, so the specific performance specifications are unknown.

The document does provide information on acceptance criteria and testing for aspects like sterilization, biocompatibility, software validation, electrical safety, and electromagnetic compatibility. This is generally summarized as compliance with recognized standards.

Here's a breakdown of the information that can be extracted from the provided text, and significant gaps where information related to diagnostic accuracy would typically be found:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific performance specifications for the device's primary function (tissue/fluid removal) are not detailed in the provided excerpt beyond a general statement of compliance. The other "performance" criteria relate to general medical device safety and functionality.

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 document for any of the performance tests. The document refers to "test results" but does not detail the nature of these tests in terms of sample size or data provenance that would be typical for a diagnostic accuracy 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 applicable/not provided. The device is a "Suction lipoplasty system" meant for "removal of tissue or fluids," not a diagnostic device that relies on expert interpretation of output to establish ground truth.

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

This information is not applicable/not provided for the same reasons as point 3.

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 information is not applicable/not provided. The device is not a diagnostic AI system, and therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation as described.

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

This information is not applicable/not provided as it is not a diagnostic algorithm. The device itself is standalone in its mechanical/electronic function, but this question typically refers to the performance of a diagnostic algorithm in isolation.

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

This information is not applicable/not provided in the context of diagnostic "ground truth." The "ground truth" for the device's technical performance would be its ability to meet its engineering specifications (e.g., proper motor function, suction power, sterilization efficacy), which are implicitly based on established engineering principles and medical device standards.

8. The sample size for the training set

This information is not applicable/not provided. This question typically refers to the development of machine learning algorithms. The device's software is stated to be designed and developed "according to a robust software development process" and "rigorously verified and validated," implying standard software engineering practices rather than machine learning training sets.

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

This information is not applicable/not provided for the same reasons as point 8.

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