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The Storz Modulith® Lithotripter Models SLK is manufactured by Storz Indication: Medical AG are indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
Storz Modulith® Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The lithotripter models described in this submission are intended for use by qualified surgeons during a variety of lithotripsy surgical procedures.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Storz Modulith® Lithotripter Model SLK, a device indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.

The information provided confirms:

• Device Identification: Storz Modulith® Lithotripter Model SLK.
• Indication for Use: Therapeutic use in the treatment of ureteric calculi in lithotripsy procedures, and noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
• Regulatory Status: Substantial equivalence to legally marketed predicate devices, classifying it as a Class II device.

However, the document does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document primarily focuses on the administrative and regulatory approval for marketing the device based on substantial equivalence, rather than providing details of specific performance studies against defined acceptance criteria.

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The Storz Modulith® Lithotripter Model SLK with Multiview option is intended for noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The Storz Modulith® Lithotripter Model SLK with Multiview option is an extracorporeal pressure wave lithotripter. The Multiview option facilitates the additional display of up to two imaging systems on the Lithotrack® monitor.

This looks like a 510(k) summary and FDA clearance letter for a medical device called the "Storz Modulith® Lithotripter Model SLK with Multiview option." This document asserts substantial equivalence to a predicate device rather than providing a detailed study demonstrating that the device meets specific acceptance criteria through performance data.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in the provided text. This is typical for a 510(k) submission where the primary argument for clearance is substantial equivalence to an already legally marketed device, rather than novel clinical performance data.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Available. The document does not provide a table of acceptance criteria or reported device performance metrics tied to specific criteria. The clearance is based on substantial equivalence.

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

• Not Applicable / Not Available. No specific test set data is provided for the "Storz Modulith® Lithotripter Model SLK with Multiview option" to demonstrate its performance against acceptance criteria. The clearance relies on the equivalence to a predicate device.

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 / Not Available. No ground truth establishment for a test set of the new device is discussed.

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

• Not Applicable / Not Available. No test set or adjudication method is mentioned for the new device.

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 lithotripter, which fragments urinary calculi. It is not an AI-assisted diagnostic imaging device, so an MRMC study with human readers improving with AI assistance would not be relevant.

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

• Not Applicable. This device is a physical lithotripter, not an algorithm, so standalone algorithm performance is not relevant.

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

• Not Applicable / Not Available. As no new performance study for the device is presented, no ground truth type for such a study is mentioned. The clearance is based on the previously established performance and safety of the predicate device.

8. The sample size for the training set

• Not Applicable. This is a hardware device (lithotripter) and not a software algorithm that would require a training set.

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

• Not Applicable. As per point 8, there is no training set for this type of device.

Summary based on the provided text:

The provided documents (510(k) Summary and FDA Clearance Letter) for the "Storz Modulith® Lithotripter Model SLK with Multiview option" do not describe a study to prove the device meets specific acceptance criteria through performance data. Instead, the clearance is based on a demonstration of substantial equivalence to an existing predicate device. The statement explicitly says: "The Storz Modulith® Lithotripter Model SLK with Multiview option for lithotripsy is substantially equivalent to the predicate device since the basic features and intended use are identical, and the design is similar. The minor differences between the Storz Modulith® Lithotripter Model SLK with Multiview option and the predicate device raises no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

Therefore, the requested information pertaining to studies, sample sizes, ground truth establishment, and expert involvement for a new performance study is not applicable and not present in this type of submission.

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