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The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

The Single Use Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in effective length of sheath from 10.0cm (shortest) to 55cm (longest). The device is packaged in a peel-open pouch with a two-year shelf life.

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary.

However, the provided document does not contain information related to an AI/ML device or its performance criteria, expert review, MRMC studies, or training/test set details. The product described is a "Single Use Ureteral Access Sheath," which is a physical medical device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through bench testing, material biocompatibility, and sterilization validation, not AI/ML model performance.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Based on the document, here's what can be inferred about the criteria for this specific device:

Device: Single Use Ureteral Access Sheath (A physical medical device, not an AI/ML diagnostic tool)

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

The document describes the performance data through bench testing and compliance with various standards. It does not present specific quantitative acceptance criteria in a table format with corresponding performance results for each criterion, but rather states that tests were "passing" and standards were "met."

Sections that cannot be addressed due to the nature of the device and information in the document:

• 2. Sample sizes used for the test set and the data provenance: Not applicable to a physical device evaluated by bench testing; no "test set" of patient data is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth in the context of AI/ML diagnostics is not relevant for this physical device.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "truth" is based on material properties, mechanical performance, and compliance with recognized standards.
• 8. The sample size for the training set: Not applicable; no AI/ML model training is described.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" discussed relate to engineering, material, and sterilization standards for medical devices, rather than the performance of an AI/ML algorithm.

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