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The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The Cynosure 1064nm Diode Laser is the laser device that delivers laser energy in the 1064nm wavelength. The Cynosure 1064nm Diode Laser is a non-invasive device that emits light energy to for the purpose of causing the therapeutic elevation of tissue temperature. The Cynosure Diode laser is a compact diode laser system. The Cynosure Diode laser's overall size, cooling needs, and electrical service requirements are substantially reduced compared to other lasers with similar power capabilities.

The provided text describes a 510(k) premarket notification for the Cynosure 1064nm Diode Laser, which is intended to provide heating for therapeutic purposes. However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the way typically found for AI/software devices.

Instead, this submission is for a physical medical device (a laser) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance Data" section describes bench testing rather than clinical study results establishing ground truth and efficacy against specific performance metrics for a diagnostic or AI device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as it does not detail an AI/software device's performance study.

Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes bench testing of a hardware device's heating capability, not a study involving a test set of data (e.g., medical images or patient records) a software algorithm would analyze.
• The "Performance Data" refers to "bench testing summaries," indicating laboratory-based tests rather than human subject testing with a specific data set.

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

• Not Applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is not established for this type of device and study described. The bench testing would likely involve engineers or technicians verifying physical parameters.

4. Adjudication method for the test set

• Not Applicable. No test set requiring expert adjudication is described.

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. This is not an AI device, and no MRMC study is mentioned.

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

• Not Applicable. This is a physical laser device, not an algorithm.

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

• For the bench testing mentioned, the "ground truth" would be objective physical measurements of temperature attained and maintained. There is no mention of clinical ground truth (e.g., patient outcomes, pathology diagnosis, or expert clinical consensus) as would be needed for a diagnostic or AI-based therapeutic device.

8. The sample size for the training set

• Not Applicable. This device is not an AI/software product, so there is no training set mentioned.

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

• Not Applicable. As there is no training set, this question does not apply.

Summary of what the document focuses on instead:

The document focuses on demonstrating Substantial Equivalence to existing FDA-cleared predicate devices (Biolase Technology, Inc. ezlase™ K083595, CYNOSURE, INC. HILT Family Laser K051537, and CYNOSURE, INC. SmoothShapes XV® System K100230). The claim is that the device has "equivalent technological characteristics and fundamental scientific technology" and the "same indications for use" as these predicates. The supporting "Performance Data" involves bench testing to show the device's ability to achieve and maintain target tissue temperatures, which aligns with its intended function but isn't a complex clinical efficacy study with ground truth as might be expected for an AI device.

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