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The W.O.M. Laser U100plus is intended for use in endoscopic surgical procedures to fragment stones. The W.O.M. Laser U100plus is indicated for use to fragment urinary stones (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.

The W.O.M. Laser U100plus is an intracorporal laser lithotripter in Urology and Gastroenterology. It transmits pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone. The device incorporates an internal water cooling cycle with a water-air heat exchanger system. It provides safety features and displays parameters on the operator panel. Differences from the predicate W.O.M. Laser U100 include a minor increase in pulse energy and pulse frequency, and the option of a double pulse setting.

The provided text describes a 510(k) submission for the W.O.M. Laser U100plus, a device intended for stone fragmentation. However, it does not explicitly state acceptance criteria in a table format with specific performance metrics (e.g., success rates, fragmentation times) that the device must meet.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technical characteristics, and safety/effectiveness data. The "study" mentioned isn't a performance study with defined quantitative acceptance criteria and results against those criteria, but rather a general statement about supporting data.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not available:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document describes compliance with standards and comparative statements regarding predicates, which function as "acceptance criteria" within the context of a 510(k) summary focused on substantial equivalence. It does not provide specific quantitative benchmarks or thresholds for performance (e.g., "95% stone clearance rate").

Study Details

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

   • Sample Size: Not specified. The document broadly states "In vitro, in vivo and clinical data has been provided." No specific number of cases or samples for these studies is mentioned.
   • Data Provenance: Not specified (e.g., country of origin). The document does not indicate whether data was retrospective or prospective.

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

   • Not specified. The document does not describe the establishment of a "ground truth" using experts for a test set, as would be common in an AI evaluation. Instead, the studies referred to are to demonstrate safety and efficacy of a medical device.

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

   • Not applicable. This concept typically applies to studies involving human readers and interpretation of data (e.g., imaging studies) where adjudicated ground truth is established. The document describes studies on a laser lithotripter, not an interpretive AI system.

4. 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 is not an AI device or an imaging interpretation system. The device is a surgical laser, and the studies described are related to its direct physical performance.

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

   • Not applicable. This is not an algorithm or AI system. The device itself is a standalone medical instrument. The "study" refers to the performance of the device itself in in vitro, in vivo, and clinical settings.

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

   • The concept of "ground truth" in the AI sense is not directly applicable here. The "truth" being established in the in vitro, in vivo, and clinical studies would likely relate to objective measurements of stone fragmentation, safety parameters (e.g., tissue damage), and clinical outcomes relevant to the device's intended use. Specific details on how effectiveness (e.g., successful fragmentation) was measured or validated are not provided in this summary.

7. The sample size for the training set:

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

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

   • Not applicable, as there is no training set for an AI model.

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