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The Medical Diode Laser (Model: M2-GK) is indicated for use in surgical applications requiring the vaporization. incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis.

The Medical Diode Laser device incorporates a dual wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980mm and 1470nm respectively. The device also incorporates a red (650mm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200um, 400μm, 600μm, 800μm and 1000um diameter respectively.

This document is a 510(k) Premarket Notification for a Medical Diode Laser, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study for a novel device. The information provided is primarily related to non-clinical bench testing and software verification, not clinical performance or impact on human readers.

Therefore, many of the requested categories for a study proving acceptance criteria will either be "Not Applicable" or the information cannot be found in the provided text.

Here is an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in this context)

The document does not specify quantitative acceptance criteria for clinical device performance in the way one might expect for a diagnostic or AI-powered device. Instead, the "performance" demonstrated is adherence to electrical safety and performance standards for laser products.

Study Information (Based on the document):

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

   • See table above. As explained, these are technical and regulatory performance criteria rather than typical clinical acceptance criteria for an AI or diagnostic device.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable. The document states "Clinical data: Not applicable." The "Performance Testing - Bench" refers to laboratory bench testing of the laser's physical parameters and safety, not a test set of patient data. The provenance of such bench testing data would typically be the manufacturer's internal testing facilities, but this detail is not provided.

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

   • Not applicable. Not a clinical study. Ground truth in this context would be the calibrated measurement instruments used for technical performance testing.

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

   • Not applicable. Not a clinical study.

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. The document explicitly states "Clinical data: Not applicable." This device is a surgical laser, not an AI-assisted diagnostic tool.

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

   • Yes, implicitly. The "Performance Testing - Bench" and "Software Verification and Validation Testing" are essentially standalone tests of the device's technical functionality and software, without human users interacting in a clinical evaluation sense. The device itself (Medical Diode Laser) operates as a standalone piece of equipment for surgical procedures.

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

   • The "ground truth" for the non-clinical performance and safety testing is established by international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and the accuracy specifications defined by the manufacturer for the device's output parameters. For software, the ground truth is adherence to the validated software requirements.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

   • Not applicable. See #8.

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