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Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.

The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.

This document is a 510(k) summary for the Cynosure SculpSure device, which is a diode laser system intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical performance data for specific clinical outcomes. The clinical performance is described in terms of "affecting the appearance of visible fat bulges."

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: "Not applicable, no change in indication for use." This implies that the current 510(k) submission did not include a new clinical test set to prove device efficacy for the stated indications. Instead, it relies on the previous approvals of its predicate devices.
• Data Provenance: Not applicable for a new clinical test set in this submission. The original predicate devices' approvals would have contained this information. It is not mentioned whether any retrospective or prospective data was used for this specific submission beyond the predicate device references.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable as no new clinical test set was submitted for this 510(k) for evaluating efficacy.

4. Adjudication Method for the Test Set:

• Not applicable as no new clinical test set was submitted for this 510(k).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No MRMC comparative effectiveness study is mentioned in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and safety, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The SculpSure device is a physical laser system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device's performance is inherently linked to its physical output and application by a user.

7. The Type of Ground Truth Used:

• For the intended use of "affecting the appearance of visible fat bulges," the ground truth in previous studies for the predicate devices (or the original SculpSure K150230) would likely have involved clinical assessment of fat reduction (e.g., circumferences, caliper measurements, imaging such as ultrasound or MRI, and potentially patient/physician satisfaction surveys). However, this specific 510(k) does not detail new efficacy studies.
• For non-clinical tests:
  • Software verification and validation: Ground truth is the predefined functional requirements and specifications of the software.
  • Power output testing: Ground truth is the specified power output range.
  • Biocompatibility: Ground truth is ISO 10993-1 standards.
  • Electrical safety and EMC: Ground truth is the specified international standards (e.g., IEC 60601-1).

8. The Sample Size for the Training Set:

• Not applicable as this 510(k) is not for an AI/algorithm-based device that requires a training set in the typical machine learning sense. The device is a physical laser system.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable for the same reason as point 8.

Summary of the Study that Proves Device Meets Acceptance Criteria (based on the provided document):

The provided document (K160470) is an administrative change to a previous 510(k) and refers back to the original substantial equivalence determination for SculpSure (K150724 and K150230). This specific submission does not contain new clinical studies to prove efficacy. Instead, it relies on demonstrating substantial equivalence to its own previously cleared versions and other predicate devices, citing "no change in indication for use."

The "studies" that support the device meeting acceptance criteria (in terms of safety and performance for its intended use) are:

• Non-clinical tests:
  • Software verification and validation.
  • Power output testing.
  • Electromagnetic compatibility (EMC) and electrical safety testing (per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
  • Biocompatibility assessment (per ISO 10993-1).

These non-clinical tests aimed to ensure the device's technical specifications, safety, and compatibility were met, demonstrating that the device "should perform as intended in the specified use conditions." The efficacy for "non-invasive lipolysis of the abdomen and flanks" was established in the earlier 510(k) submissions for the predicate SculpSure devices.

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