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The SmartLipo Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

The SmartLipo Laser is a Nd: YAG laser system. It emits a 1064nm wavelength. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 65" x 23" x 68" (LxWxH). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

This response is based on the provided 510(k) Summary for the Cynosure SmartLipo Nd: YAG Laser system (K062321).

Observations from the Provided Document:

The provided 510(k) Summary explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

This means the submission for the SmartLipo Laser did not include any studies or data pertaining to device performance against acceptance criteria in a clinical or non-clinical setting. The filing relies on comparison to a predicate device to establish substantial equivalence.

Therefore, for the specific questions requested, many of them cannot be answered from the provided document as no such studies were conducted or reported.

Detailed Breakdown based on Document (K062321):

Given the information provided, the device's acceptance criteria and the study proving it meets those criteria are not described in a manner typical for performance studies as no clinical or nonclinical performance data was submitted. The submission relies on "substantial equivalence" to a predicate device.

Here's how the questions relate to the information in K062321:

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

   • Not applicable / No data provided. The document states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." Therefore, no specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcomes) or reported device performance against such criteria are present.

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

   • Not applicable / No data provided. Since no nonclinical or clinical performance studies were conducted or submitted, there is no test set, sample size, or data provenance to report.

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 data provided. Without a test set and associated performance studies, there is no ground truth, expert panel, or their qualifications to report.

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

   • Not applicable / No data provided. No test set means no adjudication method was used or reported.

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

   • No, an MRMC study was not done. This device is a laser system, not an AI-assisted diagnostic tool for human readers. No such study would be applicable or expected for this type of device.

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

   • Not applicable / No data provided. This device is a laser system which is a physical surgical tool; it is not an algorithm, so a standalone algorithm performance study is irrelevant.

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

   • Not applicable / No data provided. As no performance studies were submitted, no ground truth was established for this purpose.

8. The sample size for the training set

   • Not applicable / No data provided. This is not an AI/ML device that requires a training set.

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

   • Not applicable / No data provided. As this is not an AI/ML device, there is no training set or ground truth for it.

Summary based on Substantial Equivalence:

The provided 510(k) relied on demonstrating substantial equivalence to a predicate device (Laserscope Lyra Series Nd: YAG Laser system), rather than providing new performance studies. The core argument for acceptance was:

• Same indication for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, plus laser-assisted lipolysis.
• Same principle of operation: Nd: YAG laser system.
• Essentially the same wavelength and pulse energy range as the predicate device.

The "conclusion" stated in the summary is: "The SmartLipo laser is a safe and effective device for the indicated uses," which is a regulatory conclusion based on the substantial equivalence argument, not on new clinical or nonclinical performance data submitted within this particular 510(k).

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