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The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

It is indicated in medical specialties including, but not limited to:

• Urology
• Gastroenterology
• Arthroscopy
• Neurosurgery
• Pulmonary
• Gynecology
• ENT
• Dermatology
• Plastic Surgery
• General Surgery

This Special 510(k) of the modified device MH01 is submitted due to Device Modifications of the already cleared device Litho DK30 (K141403Q): MH01 differs from Litho DK30 (K141403Q) about: - housing of components: tower frame instead of desktop - graphic user interface The modified device MH01 has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. The modified and unmodified devices have the same components, the same laser source emission specifications and the same controlling principles. Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.

This document is an FDA 510(k) premarket notification for a medical device called MH01. It describes modifications made to an already cleared device, the Litho DK30, and asserts that the MH01 is substantially equivalent to the predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" are compliance with relevant safety and performance standards for medical electrical equipment and laser products. The reported device performance is its successful passing of these tests.

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

• Sample Size: The document does not specify a "test set" in terms of subject or patient data. The testing described is engineering and electrical safety testing of the device itself. Therefore, the "sample size" is effectively one (1) device (the modified MH01) that underwent the tests.
• Data Provenance: Not applicable in the context of patient data. The testing was performed on the device by Quanta System SPA in Italy, as indicated by the applicant's address. The testing seems to be prospective (performed on the newly modified device).

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

• Not applicable. The ground truth for this type of testing (electrical safety, EMC, laser safety) is established by adherence to the published standards (IEC, FDA CFR) themselves. The "experts" would be the engineers and technicians performing the tests and comparing the results against the limits and criteria defined in these standards. Their qualifications would be in electrical engineering, safety testing, and laser physics, but specific details are not provided in this regulatory document.

4. Adjudication method for the test set:

• Not applicable. This is not a study involving human reader interpretation or clinical endpoints. The "adjudication" is a direct comparison of measured device parameters against the limits set by the referenced international standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a modification to a laser surgical instrument, which does not involve AI or human interpretation in the way typical MRMC studies for diagnostic AI would.

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

• No, a standalone algorithm performance study was not done. This device is a physical laser system, not an algorithm.

7. The type of ground truth used:

• The ground truth used for this submission is compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and 21 CFR 1040.10/1040.11). These standards define the acceptable performance, safety limits, and testing methodologies for medical electrical and laser equipment.

8. The sample size for the training set:

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

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

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

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