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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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The W.O.M. Laser U100 is intended for use in endoscopic surgical procedures . to fragment stones.
The W.O.M. Laser U100 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 U100 is indicated for use in the contact mode to fragment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.

The W.O.M. Laser U100 has the same intended use, identical design features and principles of operation as the predicate device W.O.M. Laser U100 (K011175). Differently to the predicate device the W.O.M. Laser U100 described in this premarket notification is not only indicated for use to fragment urinary stones but also biliary stones. In addition, the W.O.M. Laser U100 has the same intended use and indication for use, similar design features and similar principles of operation as the Candela MDL 2000 LaserTripter (K901723).
All three devices are intended for use in endoscopic surgical procedures to fragment stones. Both the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter are indicated for use to fragment urinary and biliary stones in the contact mode during closed surgical procedures.
The W.O.M. Laser U100 and the predicate device W.O.M. Laser U100 (K011175) use identical physical processes to generate the laser beams and method of transmission to the stone. Although the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter (K901723) generate their respective laser beams through different physical processes, the characteristics of the treatment beams (wavelength, pulse energy, pulse duration and pulse frequency) are similar. Moreover, the method of transmission to the stone (laser fiber) is similar and both devices provide aiming beams to allow visual indication of the stone location.
All three devices incorporate an internal water cooling cycle with a water-air heat exchanger system. In addition, all three devices provide identical or similar safety features and identical or similar parameters are displayed on the operator panel of the devices.
Finally, the W.O.M. Laser U100 and the predicate devices transmit 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 provided text describes a 510(k) summary for the W.O.M. Laser U100, a medical device for fragmneting kidney, ureter, bladder and biliary stones. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML product. Therefore, many of the requested categories related to algorithm performance, training sets, and expert evaluations are not applicable or cannot be extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or performance metrics in the way one would for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance

• The summary states that "In vitro, in vivo and clinical data has been provided to demonstrate that the W.O.M. Laser U100 is safe and effective for the fragmentation of biliary stones in closed surgical procedures."
• Sample size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable as this is a medical device approval based on substantial equivalence and clinical data, not an AI/ML algorithm requiring expert-established ground truth for a test set. There's no mention of a human-in-the-loop diagnostic process being evaluated.

4. Adjudication Method

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations for AI/ML algorithm evaluation, which is not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not performed or reported in the provided text. This type of study is relevant for AI-assisted diagnostic tools, not for a laser lithotripter directly.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The W.O.M. Laser U100 is a physical device, not a standalone algorithm. The "in vitro, in vivo and clinical data" refers to direct performance of the device.

7. Type of Ground Truth Used

• The document implies that clinical outcomes (fragmentation of biliary stones) and potentially pathology/imaging evidence of stone fragmentation served as the ultimate ground truth in the "in vitro, in vivo and clinical data." However, the exact nature of this "ground truth" (e.g., complete fragmentation, certain size reduction, clinical success rates) is not detailed in this summary.

8. Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This device is not an AI/ML algorithm.

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Ask a specific question about this device