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The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anteriorto-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of accuracy or clinical performance. The submission is for a reprocessed medical device (Intracardiac Echocardiography Catheter), and the studies described are primarily focused on demonstrating that the reprocessed device is as safe and effective as the predicate device and operates as originally intended.

Specifically, the document focuses on:

• Bench and laboratory testing: To demonstrate the performance (safety and effectiveness) of the reprocessed device.
• Comparison to a predicate device: Asserting that the reprocessed device is substantially equivalent to legally marketed predicate devices.
• Validation of reprocessing methods: Ensuring cleaning, sterilization, and functional integrity after reprocessing.

Therefore, many of the requested categories for a study demonstrating clinical performance or diagnostic accuracy are not applicable to this submission.

However, I can extract the relevant information regarding the testing performed and the general "acceptance criteria" through comparison to the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for image quality metrics) or their exact reported performance values. Instead, it states that the reprocessed device meets the functional and safety requirements to be considered equivalent to the predicate. The "performance" is implicitly "as safe and effective as the predicate" and "operates as originally intended."

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

The document does not specify exact sample sizes for the "test set" (e.g., number of reprocessed catheters tested for each criterion). The testing would have been done on a sufficient number of reprocessed devices to validate the reprocessing methods and ensure consistency. The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions, which is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin of the data is not explicitly stated but is implied to be within the US (given FDA submission).

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

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study involving diagnostic accuracy with expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a MRMC comparative effectiveness study was not conducted or described. The focus is on the substantial equivalence of the reprocessed device to its predicate through engineering and functional testing.

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

This information is not applicable/not provided. The device is an Intracardiac Echocardiography Catheter, not an AI algorithm. The functional testing described is effectively a standalone performance assessment of the physical device.

7. The type of ground truth used

The "ground truth" for the functional and safety testing would be:

• Engineering specifications of the original device.
• Industry standards and regulatory requirements for medical device safety and performance (e.g., biocompatibility standards, sterilization efficacy).
• The performance characteristics of the new/unreprocessed predicate device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device submission, as it relates to a physical medical device and its reprocessing, not a machine learning algorithm.

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

This information is not applicable/not provided for the same reason as above.

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