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The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Orchestra Hydrophilic Guidewire. The document states that the device is substantially equivalent to a previously cleared device (K131072) and details the nonclinical tests performed to support this claim, specifically focusing on a modification to the hydrogel coating. However, the document does not contain acceptance criteria or performance metrics that would typically be reported as "reported device performance." It also does not detail a specific "study" in the sense of a standalone algorithm or a comparative effectiveness study with human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria, as this information is not present in the provided text.

Based on the information available, here are the details related to the nonclinical testing mentioned:

• 1. Table of acceptance criteria and the reported device performance:

  • Not provided. The document states that "all current product requirements and specifications were met" for the modified coating. However, the specific requirements and their numerical acceptance criteria are not detailed, nor are the specific performance results for each criterion.

• 2. Sample size used for the test set and the data provenance:

  • Not provided. The document states "Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating."
  • The nature of the tests (e.g., durability, reliability) suggests laboratory testing, not human patient data.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. This was bench testing, not a clinical study requiring expert ground truth for interpretation of medical data.

• 4. Adjudication method for the test set:

  • Not applicable. This was bench 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:

  • No. This is a medical device (guidewire), not an AI/imaging diagnostic device.

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

  • No. This is a medical device (guidewire), not an algorithm.

• 7. The type of ground truth used:

  • Not applicable. The "ground truth" for bench testing would be the physical/chemical properties and functional performance measured against predefined specifications.

• 8. The sample size for the training set:

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

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

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

In summary, the provided document focuses on a change to a medical guidewire's coating and confirms that the modified device continues to meet existing product requirements through bench testing. It does not provide the specific details of a study with acceptance criteria and performance data as requested in the format of a clinical or AI diagnostic study.

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