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The BiFlex Evo 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 Evo 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.

This document is a 510(k) summary for a medical device called "Bi-Flex Evo," a ureteral access sheath. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Analysis of the provided text reveals that this document focuses on a physical medical device (a urological catheter/sheath) and its mechanical performance, biocompatibility, and sterilization, rather than an AI-powered diagnostic or imaging device.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML-based medical device (such as sample size for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document discusses "bench testing" to demonstrate mechanical strength and "biocompatibility" testing, which are standard for physical medical devices.

Here's the relevant information that can be extracted from the document, along with explanations for why other requested information is not present:

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

The document states: "All bench testing results confirmed that the products described in this submission met the necessary specification." However, it does not explicitly list the quantitative acceptance criteria for these tests (e.g., specific tensile strength values, burst pressures, etc.) nor the exact numerically reported performance results. It only provides a qualitative statement of meeting specifications.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

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

• Not Applicable. This pertains to a physical device, not an AI model. "Test set" in this context would refer to the number of physical units tested. The document does not specify the number of devices used for bench testing, biocompatibility, or sterilization validation. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing as it's not based on patient data.

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. Ground truth in the context of AI/ML refers to labels for data. For a physical device, performance is evaluated against engineering specifications and international standards, not expert consensus on data interpretation.

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

• Not Applicable. This refers to methods for establishing ground truth for data labeling, which is not relevant for a physical medical device's performance testing.

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. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This is a physical device (ureteral access sheath), not an imaging system or AI diagnostic tool.

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

• Not Applicable. This refers to AI algorithm performance. This device is a physical instrument.

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

• The "ground truth" for a physical device like this is its adherence to engineering specifications, material properties, and performance standards (e.g., mechanical strength, biocompatibility, sterility) as defined by established industry and regulatory guidelines (e.g., ISO, FDA guidance documents). There is no "expert consensus" on imaging or clinical outcomes data for its function.

8. The sample size for the training set

• Not Applicable. This refers to AI model training data.

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

• Not Applicable. This refers to AI model training data ground truth.

Summary of Device Performance/Compliance (as per 510(k) Summary):

The manufacturer conducted bench testing to demonstrate that the Bi-Flex Evo Ureteral Access Sheath:

• Provides adequate mechanical strength for its intended use.
• Meets necessary specifications for performance.
• Is biocompatible in accordance with ISO 10993.
• Has validated sterilization processes in accordance with recognized industry standards.
• The material change in the dilator (LDPE to Polyurethane) provides increased flexibility for safer introduction and does not affect the intended use or fundamental scientific technology.
• The addition of printed marks aids in visualization of penetration depth for safer insertion.

The conclusion is that the Bi-Flex Evo is substantially equivalent to its predicate device (Bi-Flex Ureteral Access Sheath K140441) and is safe and effective for its intended use.

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