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The STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The Storz Modulith SLK is a modification of the previously cleared Storz Modulith SLK, K011700. The device consists of a Shockwave Generator, an operator interface/touch panel, and a coupling cushion. Shock waves are generated when a rapid current pulse changes the diameter of a cylindrical shaped body. The shock waves are focused by a parabolic reflector. A water circuit is used to for generating the required coupling pressure.

The Modulith SLK has been modified to include an integrated patient table, the Lithotrack optical coupling C-Arm alignment mechanism was replaced with the crosshair manual aiming mechanism used in the Modulith SLX-F2 device (K072788), and an updated user interface that includes patient table movement control. It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney and the upper ureter. The modifications incorporated do not alter the intended use or the fundamental technology and also does not raise any issues of safety and effectiveness.

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

The provided document is a 510(k) Summary for a medical device called the "Storz Modulith SLK," which is an extracorporeal shock-wave lithotriptor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a novel AI algorithm might.

Therefore, the requested information elements related to AI algorithm performance (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for training) are not applicable to this type of submission. This document describes a modification to an existing, cleared device, and the focus is on physical and technical equivalence.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this conventional medical device submission are primarily based on demonstrating that the modified device has substantially equivalent technological characteristics and performance to its predicate device, and that the modifications do not raise new issues of safety or effectiveness.

Here's the table of core technological characteristics and performance parameters, comparing the subject device to its predicate:

Table 1: Acceptance Criteria and Reported Device Performance (Technological Characteristics)

In addition to technological characteristics, specific shock wave acoustic parameters were measured:

Table 2: Acceptance Criteria and Reported Device Performance (Shock Wave Acoustic Parameters)

The document states: "The results are found similar to the predicate device characteristics," implying that these measured values meet the "acceptance criteria" of being comparable to the predicate.

The Study that Proves the Device Meets Acceptance Criteria

The study described is a non-clinical performance and safety testing focused on demonstrating substantial equivalence.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving patient data or images to test an algorithm. It's bench testing of a physical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance (e.g., pressure measurements) is established by calibrated instruments and engineering standards, not expert radiologists.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

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

   • For the physical characteristics and acoustic parameters: Measurement against established engineering standards and specifications. The shock wave characteristics were measured "according to the guideline described in the consensus standard IEC 61846 'Ultrasonics- Pressure pulse lithotriptcrs- Characteristics of fields' (1998)." A glass fiber hydrophone was used for measurements.
   • For safety: Compliance with recognized safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, and IEC61846).

7. The sample size for the training set: Not applicable. This is not an AI device (no training set).

8. How the ground truth for the training set was established: Not applicable.

In summary, the study described is a comprehensive bench testing and safety evaluation, rather than a clinical trial or an AI performance study. The "acceptance criteria" are the established performance parameters of the predicate device and relevant industry standards for safety and acoustic measurements. The "study" consisted of performing these measurements and tests on the modified device to confirm its equivalence and adherence to safety requirements.

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