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Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

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

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

• Sample Size for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

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, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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 rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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