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The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.

The Williams Cystoscopic Injection Needle is a semi-rigid injection needle. It is provided in 3.7 or 5.0 French sizes with 35 or 45 centimeters long polyurethane catheter, which ends with a 7 or 8 millimeter length stainless steel beveled tip cannula that is available in 20 to 25 needle gages. The subject device is sterilized with EtO and is intended for one-time use.

The provided text describes a medical device, the Williams Cystoscopic Injection Needle, and its substantial equivalence application (K171602) to the FDA. The submission focuses on demonstrating that the device meets design and performance requirements through a series of tests.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample sizes used for the Biocompatibility, Shelf Life, Functional Verification, or Dimension Verification tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the involvement of experts to establish a "ground truth" for the performance tests. The tests described (biocompatibility, shelf life, functional, dimensional) typically rely on standardized laboratory procedures and measurements against predetermined specifications, rather than expert interpretation of a 'truth' in a clinical context.

4. Adjudication Method for the Test Set:

Given the nature of the performance tests described (laboratory-based measurements and compliance with standards), an "adjudication method" like 2+1 or 3+1 is not applicable or mentioned. Acceptance is typically based on whether measured values fall within predefined ranges or meet specific pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed or described. The device is an injection needle, and the testing focuses on its physical and functional properties, not on diagnostic or interpretive accuracy that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This concept is not applicable to the Williams Cystoscopic Injection Needle. This device is a manual, single-use medical instrument and does not involve algorithms or AI. Therefore, no standalone algorithm performance was assessed.

7. Type of Ground Truth Used:

For the performance tests mentioned, the "ground truth" implicitly refers to:

• Biocompatibility: Adherence to established biological safety standards (ISO 10993-1).
• Shelf Life: Stability of physical and functional properties over time, measured against initial design specifications.
• Functional Verification: The device performing its mechanical and operational actions as designed.
• Dimension Verification: Adherence to the specified dimensional blueprints and tolerances.

These are not "expert consensus, pathology, or outcomes data" in the traditional sense, but rather objective compliance against engineering specifications and international standards.

8. Sample Size for the Training Set:

The document does not mention a training set. This is because the device is a physical instrument, not a learning algorithm or AI, therefore, a training set is not relevant.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for this device.

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