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The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2.8 French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion.

The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°.

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.

The provided document is a 510(k) summary for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and the specifics of a study proving device performance in the context of AI/machine learning.

The document states: "Biocompatibility and bench performance testing was performed to demonstrate the safety and performance of the Cook® Fiber Optic bundle and the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath when used together. Testing was performed by Cook Urological, Incorporated and an independent laboratory in accordance with recognized standards. All test results were acceptable."

This indicates that some testing was done, and it met acceptance criteria, but the criteria themselves and the specific numerical results are not provided in this summary. Furthermore, this device is a traditional medical device (fiber optic bundle and access sheath), not an AI/ML-driven device. Therefore, questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies for AI improvement are not applicable to the information contained in this document.

Given the information provided, here's what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Testing performed by Cook Urological, Incorporated and an independent laboratory. No specific country of origin or whether it was retrospective/prospective is mentioned. Given the nature of bench testing for a physical medical device, it would likely be laboratory-based rather than clinical data provenance.

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 this is not an AI/ML device requiring expert ground truth for diagnostic accuracy. Testing was for device safety and performance (e.g., physical characteristics, biocompatibility).

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

• Not applicable for the type of bench and biocompatibility testing described for this traditional medical 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:

• No, this is not an AI/ML device. Therefore, no MRMC study comparing human readers with/without AI assistance was performed or described.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable in the context of diagnostic AI. For physical device performance, "ground truth" would be established by validated test methods, adherence to engineering specifications, and recognized standards for biocompatibility.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

• Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

In summary, the provided 510(k) summary (K072521) for the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath describes a traditional medical device. The document confirms that "Biocompatibility and bench performance testing was performed" and "All test results were acceptable," but it does not provide the specific numerical acceptance criteria or the detailed results of these tests. Many of the questions posed are relevant to AI/machine learning devices and therefore do not apply to the information available in this 510(k) submission.

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