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The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:

• Dual wavelengths A
• A Temperature monitoring system

The provided text describes a 510(k) submission for a Diode laser therapy device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a performance study in terms of medical outcomes, nor does it detail a study proving device performance in a clinical context with human interaction.

Instead, the document focuses on non-clinical tests to establish safety and fundamental technical specifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document provides technical specifications and biocompatibility test results, which can be interpreted as fulfilling non-clinical acceptance criteria. These are compared against predicate devices.

The study that proves the device meets (these non-clinical) acceptance criteria:

The document refers to a "Non-Clinical Test Conclusion" (Section 7.0) and lists various tests, including:

• Performance testing: The technical specifications (Table 1) indicate measurement and verification of parameters like wavelength, max power, output mode, pulse width, cooling, size, weight, fuse, laser output power, fiber diameter, and aiming beam. The compliance with these specifications shows that the device meets its stated technical design and performance parameters.
• Biocompatibility testing: As detailed in Table 2, these tests were performed according to ISO standards:
  • Cytotoxicity (ISO 10993-5)
  • Irritation (ISO 10993-10)
  • Sensitization (ISO 10993-10)
  • Acute systemic toxicity (ISO 10993-11)
  • Pyrogen test (ISO 10993-11)
  • In vitro hemolytic test (ISO 10993-4)
• Electrical Safety & EMC testing: Compliance with IEC 60601-1_2005+A1_2012, IEC 60825-1_2014, IEC 60601-2-22_2007+A1_2012 for electrical safety and IEC 60601-1-2_2014 for EMC.

These non-clinical tests collectively form the "study" that proves the device meets the listed acceptance criteria for safety and basic functionality in a laboratory setting.

Regarding the other specific questions, the document states very clearly:

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 for clinical performance. The document explicitly states: "No clinical study implemented for the Diode laser therapy device." (Section 8.0).
• For the non-clinical tests (technical specs, biocompatibility, electrical safety, EMC), device units or material samples would have been used, but specific sample sizes and provenance for these types of engineering/laboratory tests are not provided in this summary.

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 clinical ground truth was established as no clinical study was conducted.

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

• Not applicable. No clinical test set requiring adjudication was used.

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 not an AI-assisted diagnostic or imaging device. No MRMC comparative effectiveness study was done.

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

• Not applicable. This device is a laser therapy device, not an algorithm or AI system. Its performance is evaluated through direct technical and safety tests, not standalone algorithm performance.

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

• Not applicable for clinical performance. The "ground truth" for the non-clinical tests are international standards and predefined technical specifications (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety, stated power outputs, etc.).

8. The sample size for the training set

• Not applicable. This device is not an AI system that requires a "training set."

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

• Not applicable. As above, no training set was used.

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