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The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength 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 Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.

The Cynosure Smartlipo Multiwavelength laser with 1440nm wavelength is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. It is a laser with wavelengths of 1064 nm, 1320 nm, and 1440 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 document is a 510(k) summary for a medical laser system. The information provided does not describe a study involving acceptance criteria for device performance based on clinical metrics, nor does it detail a clinical study with human readers or an AI component. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

Analysis of the Provided Text:

The document is a 510(k) Summary for the Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength. This type of submission to the FDA focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a detailed clinical study with performance metrics in the way your request implies.

The core of this submission is a comparison to a predicate device, not a clinical trial with specific performance metrics and acceptance criteria for the new device itself.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance are not present in this type of regulatory document.

Here's how each of your requested points relates to the provided text:

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

Reasoning: The 510(k) summary states: "The Cynosure Smartlipo Mutliwavelength Laser with 1440nm wavelength is a safe and effective device for the 'indications for use' specified." This is a conclusion of equivalence, not a report against specific clinical performance criteria. The document lists "Nonclinical Performance Data: None" and "Clinical Performance Data: none," indicating that the submission did not rely on new performance data to establish safety and effectiveness, but rather on the equivalence to an existing device.

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

• Sample Size for Test Set: Not applicable. No test set (in the context of clinical performance evaluation) is mentioned.
• Data Provenance: Not applicable. No clinical data is presented.

Reasoning: The document explicitly states "Clinical Performance Data: none." This means no clinical study data with test sets was used for this 510(k) submission.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

Reasoning: Since no clinical data or test set was used, there was no need for experts to establish ground truth for performance evaluation.

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

• Adjudication Method: Not applicable.

Reasoning: No clinical test set or performance evaluation requiring adjudication was conducted or presented.

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

• MRMC Study Done: No.
• Effect Size: Not applicable.

Reasoning: This is a laser device, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader, multi-case study, particularly one involving AI, is entirely irrelevant to this submission.

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

• Standalone Performance Study: No.

Reasoning: This is a physical laser device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

• Type of Ground Truth: Not applicable.

Reasoning: As no clinical studies or performance evaluations were conducted for this submission, no ground truth data was generated or used.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable.

Reasoning: This device does not involve machine learning or AI, so there is no training set in the context of algorithm development.

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

• Ground Truth Establishment for Training Set: Not applicable.

Reasoning: As there is no training set for an algorithm, the establishment of its ground truth is also not applicable.

Conclusion based on the provided document:

The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength received 510(k) clearance (K091537) based on demonstrating substantial equivalence to a predicate device (also the Cynosure Smartlipo Multiwavelength Laser, but presumably without the 1440nm wavelength or with a different history). The key arguments for substantial equivalence were:

• Identical indications for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis.
• Same principle of operation: Nd:YAG laser with 1064 nm, 1320 nm, and 1440 nm wavelengths.
• Similar laser parameters to the predicate device.

The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: none," indicating that the clearance was achieved without new performance studies or data evaluating specific acceptance criteria for the new device's functions as described in your request. Instead, it relies on the established safety and effectiveness of the existing predicate device.

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