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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 a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.

The provided document, a 510(k) Premarket Notification summary for the Lotuxs Medtech (Suzhou) Co., Ltd. Powersculp laser lipolysis system, explicitly states:

"No clinical tests were provided for this pre-market notification." (Page 7, Section 9. Clinical Tests)

Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria, as no clinical studies were submitted. The acceptance criteria and the study details requested cannot be extracted from this document because such a study was not performed or submitted as part of this 510(k) application.

The 510(k) clearance for this device was based on non-clinical tests demonstrating substantial equivalence to a predicate device (K191068 Powersculp laser lipolysis system), not on a clinical effectiveness study.

Here's an breakdown of the information that can be extracted from the provided document, in relation to the prompt's requests:

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

• Acceptance Criteria (Implied by Non-Clinical Testing): The acceptance criteria for this 510(k) submission are based on demonstrating that the proposed device performs as intended and is as safe and effective as the predicate device through non-clinical testing. This primarily involved meeting engineering specifications and safety standards.
  • Software verification and validation: Software performs as intended.
  • Power Output: Meets specification.
  • Electromagnetic Compatibility and Electrical Safety: Complies with IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Patient contacting materials assessed per ISO 10993-1 and found to be biocompatible.
• Reported Device Performance (from Non-Clinical Tests): The document confirms that the device met these criteria:
  • Software verification and validation performed, demonstrated software performs as intended.
  • Testing confirmed power output meets specification.
  • EMC and electrical safety testing performed, results confirmed the device meets the standards.
  • All patient contacting materials assessed and found biocompatible.

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

• Not applicable as no clinical test set was used. Non-clinical tests would involve specific units of the device and testing materials, but these are not analogous to patient sample sizes for clinical studies.

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

• Not applicable as no clinical test set requiring expert ground truth was used.

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

• Not applicable as no 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:

• Not applicable as no clinical effectiveness study, specifically an MRMC study, was conducted or submitted. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser lipolysis system, not an algorithm, so standalone performance in the context of an algorithm is irrelevant.

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

• Not applicable for clinical ground truth as no clinical studies were performed. For the non-clinical tests, "ground truth" would be the engineering specifications and safety standards against which the device performance was measured.

8. The sample size for the training set:

• Not applicable as no AI/machine learning model requiring a training set was involved.

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

• Not applicable as no AI/machine learning model requiring a training set was involved.

In summary, the 510(k) clearance for the Powersculp laser lipolysis system (K211402) was based solely on non-clinical testing and a demonstration of substantial equivalence to a predicate device, not on clinical performance data or studies involving human subjects to establish effectiveness for the indicated use.

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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.

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