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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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Medical Diode Laser is intended to incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

The Medical Diode Laser use a wavelength 1940nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam The Medical Diode Laser (model: M2) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.

This document is about the 510(k) premarket notification for a Medical Diode Laser (M2) by Wuhan Pioon Technology Co., Ltd. The document does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/algorithm-based medical devices.

Instead, this submission is for a physical medical device (a laser surgical instrument) and focuses on demonstrating substantial equivalence to a predicate device (Fotona SkyPulse Laser Platform) based on technical characteristics and compliance with recognized performance standards.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when information is not present:

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

   • The document does not present acceptance criteria and device performance in terms of specific clinical or algorithmic metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/CADe device.
   • Instead, the "performance data" for this laser device refers to compliance with established electrical safety, electromagnetic compatibility (EMC), and software standards. The acceptance criterion is implicitly successful demonstration of compliance with these standards.

   Table: Performance Data and Compliance

   Performance Area	Acceptance Criteria (Standards)	Reported Device Performance (Compliance)
   Electrical safety	IEC 60601-1:2005+AMD1:2012+AMD2:2020

IEC 60601-2-22:2019 | Complies |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 | Complies |
| Laser product safety | IEC 60825-1:2014 | Complies |
| Software Verification and Validation | FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern) | Documentation provided and testing conducted; software considered verified and validated |

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

   • This information is not applicable and not provided as this is not an AI/CADe device that uses a test set of patient data for performance evaluation. The "tests" here refer to engineering and quality assurance tests on the physical device and its software.

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)

   • This information is not applicable and not provided as this is not an AI/CADe device requiring expert ground truth for a test set.

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

   • This information is not applicable and not provided.

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

   • This information is not applicable and not provided. The device is a surgical laser, not an AI diagnostic or assistance tool for human readers.

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

   • This information is not applicable and not provided. The device is a physical laser for surgical use, not an algorithm.

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

   • This information is not applicable and not provided in the context of clinical "ground truth" for patient data analysis. The ground truth, in the context of this device, refers to the established standards and specifications that the device must meet (e.g., electrical safety tolerances, EMC emissions limits, software functional requirements).

8. The sample size for the training set

   • This information is not applicable and not provided as this is not an AI/machine learning device.

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

   • This information is not applicable and not provided.

Summary of the Study (as described in the document):

The "study" refers to the engineering and regulatory testing performed to demonstrate the safety and effectiveness of the Medical Diode Laser (M2) by showing its compliance with recognized national and international standards.

• Type of Study: This is a premarket notification (510(k)) submission for a physical medical device. The "studies" involve compliance testing against recognized standards for electrical safety, electromagnetic compatibility, and laser product safety, as well as software verification and validation.
• Performance Data Provided:
  • Electrical safety and EMC: The device complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.
  • Software Verification and Validation: Conducted according to FDA guidance for "moderate" level of concern software.
• Conclusion: Based on these technical characteristics and performance data, the Medical Diode Laser was found to have a safety and effectiveness profile "same as the predicate device."
• Animal or clinical studies: The document explicitly states "None," indicating that no animal or clinical studies were performed or required for this 510(k) submission to demonstrate substantial equivalence.

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