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Soft tissue treatments and lithotripsy in the field of urology: In CW mode the indications for use are: Enucleation of the prostate Vaporization of the prostate Opening of ureter and urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision In PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting

The RevoLix HTL is a surgical diode-pumped solid-state laser (DPSS). The laser radiation is generated by the excitation of a solid-state Tm-YAG laser crystal using a QCW laser diode. The laser radiation is cw (continuous wave) or delivered in pulses. The emitted laser radiation has a wavelength of 2.013 nm, which is invisible infrared. RevoLix HTL is a floor standing mobile device. The device is operated by using an operating console equipped with a touch screen and control elements. The laser emission is triggered by a foot switch. The RevoLix HTL operating console enables the user selecting the desired treatment parameters such as laser power and laser energy delivery modes: continuous or pulsed. The GUI is also used to display to the user all operational settings and operational states. The laser is activated by a foot switch. The system design and software ensure that the energy output is delivered as intended by the user. The laser radiation is focused by a fiber coupler into a flexible silica laser fiber which delivers the laser radiation to the surgical site.

This document describes the premarket notification (510(k)) for the RevoLix HTL surgical laser. It establishes substantial equivalence to predicate devices, thus clinical data was not required. Therefore, the information provided focuses on non-clinical performance testing and technical comparisons rather than clinical studies or human reader performance.

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

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

The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics with PASS/FAIL thresholds. Instead, it demonstrates compliance through:

• Comparison to Predicate Devices: The primary method for proving the RevoLix HTL meets "acceptance criteria" (i.e., is safe and effective) is by showing its substantial equivalence to already cleared predicate devices. The tables on pages 5-10 compare the RevoLix HTL's technical characteristics and intended use/indications for use with its primary and secondary predicate devices (Sphinx jr. Holmium Laser K132975, RevoLix 200 K110941) and reference devices (Lumenis Pulse 120H K140388, Quanta Cyber Ho 150W K201455).
• Compliance with Standards: The "Summary of Performance Testing" section on page 12 states that validation and verification testing was conducted to confirm the device performance meets specifications and assures safety and effectiveness. It lists various IEC standards (e.g., IEC 60601-1-2, IEC 60601-1, IEC 62304, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1) that the device conforms to. These standards implicitly define acceptance criteria for safety and performance (e.g., electrical safety, electromagnetic compatibility, software life-cycle processes, usability, particular requirements for surgical laser equipment, laser product classification and requirements).
• Risk Analysis: A Risk Analysis was performed to ISO 14971:2007, and reviewed as part of IEC 60601-1, indicating that identified risks are acceptable.

Observed Device Performance (summarized from tables):

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

• No clinical test set: The document explicitly states: "Clinical data were not deemed necessary as the device is using the same intended use and key technology, operating principles and indications for use as the predicate devices." (Page 13).
• Non-clinical (testing) data: Performance testing was conducted to verify the device's performance against specifications and standards (pages 12-13). This would involve laboratory testing rather than patient data. The document does not specify "sample size" in terms of patients or data examples, but rather emphasizes compliance with engineering and safety standards. The provenance of such non-clinical data is typically tied to the manufacturer's testing facilities (LISA Laser Products GmbH, Germany) and recognized testing laboratories.

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. Since no clinical data or clinical test set was used for proving performance (due to substantial equivalence), there was no need for experts to establish ground truth in a clinical context. The performance was established through non-clinical testing against engineering specifications and industry standards.

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

• Not applicable. Due to the absence of a clinical test set requiring human interpretation of data for ground truth, no adjudication method was used. Non-clinical testing results are typically objectively measured and evaluated against predetermined specifications and compliance criteria.

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 a surgical laser, not an AI-assisted diagnostic tool. Therefore, MRMC studies and evaluations of human reader improvement with AI assistance are irrelevant to this submission.

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

• Not applicable. As stated above, this is a surgical laser device, not an algorithm or AI system. Its performance is evaluated based on its physical properties and its ability to deliver specified laser energy for surgical procedures, as validated through engineering and safety testing.

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

• Technical Specifications and Industry Standards: The "ground truth" for demonstrating the RevoLix HTL's safety and effectiveness relies on its conformance to established engineering specifications and widely recognized international medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). The "Validation and Verification testing confirms that the device performance meets specifications" (page 12). For example, the wavelength, power output, pulse characteristics, and safety features are measured and compared against their design specifications and acceptable ranges defined by these standards, and against the performance of predicate devices.

8. The sample size for the training set

• Not applicable. This is a hardware medical device and not an AI/machine learning system that requires a "training set" for model development.

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

• Not applicable. As no training set was used, no ground truth needed to be established for it.

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