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The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).

The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage. The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.

This FDA 510(k) summary describes the Dornier MAGELLAN Ureteral Access Sheath, a medical device, and its substantial equivalence to a predicate device. As such, it does not detail acceptance criteria and a study that proves the device meets specific performance metrics in the way that an AI/ML device submission would. Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through a comparison of characteristics and performance tests.

Here's a breakdown of the requested information based on the provided text, and where certain details are not applicable (N/A) because this is a traditional medical device submission, not an AI/ML B.S.E submission:

Acceptance Criteria and Device Performance

The submission states that the Dornier MAGELLAN Ureteral Access Sheath underwent various performance tests, and "All testing was found to be acceptable and substantially equivalent to those of the predicate device." While specific numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion for each test is that the device's performance must be comparable to, or meet the established benchmarks for, the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   This information is N/A for this type of submission. The performance data section lists the types of tests conducted (e.g., kink resistance, tensile strength), which are typically bench tests or material tests, not clinical studies with patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective in the way an AI/ML device would report it.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is N/A. The "ground truth" for these types of mechanical and material tests is defined by engineering specifications and established test methodologies, not by expert medical interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is N/A. Adjudication methods are relevant for clinical studies where multiple experts evaluate cases that might have ambiguous findings, which is not applicable to the performance tests listed.

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:
   This information is N/A. This device is a physical ureteral access sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is N/A. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the performance tests described (e.g., sterility, biocompatibility, kink resistance, tensile strength), the "ground truth" is typically based on engineering specifications, material standards, and validated test methods. It's not based on expert medical consensus, pathology, or outcomes data. For example, the ground truth for "kink resistance" would be defined by a specific force or angle at which the sheath begins to kink, as measured by a standardized physical test.

7. The sample size for the training set:
   This information is N/A. This device does not involve a training set as it is not an AI/ML model.

8. How the ground truth for the training set was established:
   This information is N/A. This device does not involve a training set or ground truth establishment in the context of AI/ML.

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