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The Cynosure Smartlipo MPX Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo MPX Laser is futher indicated for laser assisted lipolysis.

The Cynosure Smartlipo MPX laser with SmartSense C Module is a Nd: YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.

This submission is for a traditional 510(k) for a medical laser system. Traditional 510(k)s often rely on substantial equivalence to a predicate device rather than extensive clinical studies with specific performance criteria.

Therefore, the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are largely not applicable in the context of this specific 510(k) summary. The submission focuses on comparing the new device to an existing, legally marketed predicate device.

Here's a breakdown of why and what information can be inferred:

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

• Not Applicable. The submission does not provide acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating that the new device has the "same indications for use, the same principle of operation, and the same laser parameters as the predicate device(s)." This inherently means the "performance" should be equivalent to the predicate, as its safety and effectiveness have already been established.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No test set or clinical study exploring specific performance metrics is mentioned. The submission is a comparison to a predicate, not a de novo performance evaluation.

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)

• Not Applicable. No test set requiring ground truth established by experts is mentioned.

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

• Not Applicable. No test set requiring adjudication is mentioned.

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. This device is a laser system, 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 device is a laser system, not an algorithm.

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

• Not Applicable. No specific ground truth is established for the device itself in this submission. The "ground truth" for regulatory equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not Applicable. No training set is mentioned.

Conclusion based on the provided document:

The Cynosure Smartlipo MPX Laser with SmartSense C Module establishes substantial equivalence to its predicate device (The Cynosure YAG Family laser) by stating:

• Same indications for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including laser-assisted lipolysis).
• Same principle of operation: Nd:YAG laser with 1064 nm and 1320 nm wavelengths.
• Same laser parameters.

The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none" for the new device. This confirms that the approach was squarely based on substantial equivalence rather than new clinical trials demonstrating specific performance metrics.

The FDA's decision letter (K083379) confirms that the device was found "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. This means the device met the regulatory acceptance criteria by demonstrating similarity to an already approved device regarding its intended use, technology, and performance characteristics, without needing to conduct new, explicit performance studies.

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