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The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

The provided document is a 510(k) summary for the Bi-Flex Ureteral Access Sheath. It describes the device, its intended use, and its technological characteristics compared to a predicate device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new, non-substantially equivalent devices or AI/software as a medical device (SaMD) clearances.

This 510(k) submission primarily relies on physical and functional testing to support the claim of substantial equivalence.

Here's what can be extracted based on the provided text, while also noting what is not present:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics with defined thresholds. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the device is as safe and effective as the predicate device by meeting similar design and material specifications and passing standard physical and functional tests.
• Reported Device Performance:
  • "Results of physical and functional testing support a determination of substantial equivalents for the Bi-Flex Ureteral Access Sheath when compared to the predicate device." This is a high-level statement that general performance was found to be acceptable relative to the predicate. No specific numerical performance values are given.
  • The document lists various technological characteristics of the proposed device, which can be interpreted as design specifications that the device met to be considered substantially equivalent to the predicate. These are listed in "Table 1: Proposed Device" column. The implicit "acceptance criterion" for each of these is that it matches or is comparable to the predicate device's characteristic.

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

• Not specified. The document mentions "physical and functional testing" but does not detail the specific tests, sample sizes, or where these tests were 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/Not specified. This is not an AI/SaMD device where expert-established ground truth is typically required for a test set.

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

• Not applicable/Not specified.

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/SaMD device for which an MRMC study would be conducted.

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

• No. This is a hardware medical device, not an algorithm.

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

• Not applicable in the usual sense for clinical performance. The "ground truth" for this device's performance would be engineering specifications and standards for material properties, mechanical integrity, and biocompatibility, as confirmed through physical and functional testing.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable. This device does not involve a training set.

Summary of Study:

The study involved physical and functional testing of the Bi-Flex Ureteral Access Sheath. The details of these tests, including specific methodologies and quantitative results, are not provided in this 510(k) summary. The purpose of this testing was to demonstrate that the new device is substantially equivalent to the predicate device (ROCAMED RocaUS Platinum, K120160) by comparing their intended use, technology, principles of operation, and materials. The FDA's clearance of K140441 indicates that based on the submitted data, the agency agreed with the claim of substantial equivalence.

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