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The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.

The provided text describes a 510(k) premarket notification for the "Powersculp laser lipolysis system" and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo performance validation as one might see for an AI/ML device.

Therefore, the document does not contain the specific information required to answer questions 1-9 comprehensively for a device proving it meets acceptance criteria through clinical studies. The submission explicitly states that clinical tests were not performed for the Powersculp given its substantial equivalence to already marketed devices.

However, I can extract information related to the device's technical specifications and how the manufacturer states the device meets safety and effectiveness requirements by relying on existing predicate devices and non-clinical testing.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly lacking for the prompt's requirements:

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" to Predicates)

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence (SE) to legally marketed predicate devices. The performance is not measured against explicit clinical thresholds in this document, but rather by showing comparable technology and safety.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) based on substantial equivalence, there are no specific performance acceptance criteria like sensitivity, specificity, or accuracy for a diagnostic AI. Instead, the acceptance is based on demonstrating the proposed device is as safe and effective as the predicates. The "performance" is implicitly tied to the general performance of the predicate devices.

The table below summarizes the comparative attributes that, when deemed "similar" or "same" to the predicate, imply acceptance for a 510(k) submission.

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

• Sample Size: N/A for clinical testing. The submission states: "Lotuxs belives that the proposed device Powersculp laser lipolysis system PSP050 does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
• Data Provenance: N/A for clinical testing of the proposed device itself. Any referenced clinical data would be from the predicate devices (likely retrospective studies conducted by their manufacturers).

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

• N/A. No de novo clinical test set was used for the proposed device, as no clinical studies were performed.

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

• N/A. No de novo clinical test set was used.

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

• N/A. This device is a laser system for lipolysis, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was mentioned or required.

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

• N/A. This applies to an algorithm/AI, not a physical laser system. The "performance" of the device is its ability to perform lipolysis, not to interpret data.

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

• N/A. For this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices and robust non-clinical (bench) testing of the proposed device itself. The non-clinical tests included:
  • Software verification and validation (demonstrated performance as intended per FDA guidance).
  • Power output testing (confirmed specification).
  • Electromagnetic compatibility (EMC) and electrical safety testing (confirmed compliance with standards ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
  • Biocompatibility assessment of patient-contacting materials (per ISO 10993-1).

8. The sample size for the training set

• N/A. This device has no "training set" in the context of an AI/ML model.

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

• N/A. Does not apply to this type of device.

Summary of how the device meets acceptance criteria (implicit in a 510(k)):

The Powersculp laser lipolysis system meets the implicit acceptance criteria for a 510(k) clearance by demonstrating substantial equivalence (SE) to legally marketed predicate devices (K160470 and K150230 Sculpsure). The manufacturer asserted that the proposed device has the same indications for use, fundamental operating theory, structure, components, laser type, lipolysis method, wavelength, pulse width, cooling method, and patient attachment method as the predicate devices.

Minor differences in spot size, power density, peak power, and power supply were argued not to affect safety and effectiveness. Non-clinical tests, including software verification and validation, power output testing, electromagnetic compatibility, electrical safety testing, and biocompatibility assessment, were performed to demonstrate that the device itself is safe and performs as intended, in line with recognized standards. This approach, outlined in Section 9 and 10 of the K191068 submission, negates the need for new clinical trials for this specific device.

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