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The Medline ReNewal 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.

Device Description

The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing 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 anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.

AI/ML Overview

The provided text is a 510(k) summary for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a reprocessed medical device. It does not contain information about an AI/ML-driven device, nor does it specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance, are not applicable or cannot be extracted from this particular document.

However, I can extract the "performance" details in the context of the non-clinical testing conducted to prove substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

The document primarily focuses on demonstrating that the reprocessed device performs comparably to the original predicate device through various non-clinical tests. These tests effectively serve as the "acceptance criteria" for demonstrating substantial equivalence rather than diagnostic performance in an AI/ML context.

Acceptance Criteria (Non-Clinical Test Category)	Reported Device Performance (as stated in the document)
Functional Performance	Evaluated and found to be substantially equivalent to the predicate device. Specific tests included:
- Simulated use and artificial soiling	Not explicitly detailed, but implied successful equivalence.
- Visual inspection	Not explicitly detailed, but implied successful equivalence.
- Mechanical characteristics	Not explicitly detailed, but implied successful equivalence.
- Ultrasound transducer testing	Not explicitly detailed, but implied successful equivalence.
- Dimensional analysis	Not explicitly detailed, but implied successful equivalence.
- Electrical Safety	Not explicitly detailed, but implied successful equivalence.
- Dielectric and current leakages	Not explicitly detailed, but implied successful equivalence.
Cleaning Validation	Not explicitly detailed, but implied successful validation for reprocessing.
Biocompatibility	Not explicitly detailed, but implied successful validation.
Sterilization Validation	Not explicitly detailed, but implied successful validation. Specific tests included:
- Bioburden testing	Not explicitly detailed, but implied successful validation.
- Ethylene oxide and ethylene chlorohydrin residuals testing	Not explicitly detailed, but implied successful validation.
- Bacteriostasis/fungistasis	Not explicitly detailed, but implied successful validation.
Packaging and shelf life validation	Not explicitly detailed, but implied successful validation.
Product stability	Not explicitly detailed, but implied successful validation.
Indications for Use	Same as the predicate device: "indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart."
Technological Characteristics	Same as the predicate device: "To operate, the catheter is connected to a compatible intracardiac ultrasound console (View Mate II, ViewMate Z and Philips CX50) via a compatible ViewFlex Catheter Interface Module."

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

Not applicable. This document describes a reprocessing approval based on non-clinical engineering and biological tests, not statistical analysis of patient data or diagnostic performance of an AI model. There is no "test set" in the sense of a dataset for an AI model.

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

Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for this submission is established through validated scientific methods for medical device performance, safety, and equivalence.

4. Adjudication method for the test set

Not applicable. No adjudication method is described, as there is no "test set" requiring expert consensus.

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

Not applicable. This applies to AI/ML devices that assist human readers in diagnostic tasks. The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a reprocessed physical medical device, not an AI system.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For this type of device (reprocessed catheter), the "ground truth" is established through:

Validated engineering specifications: Proving the device meets its design requirements in terms of mechanical, electrical, and dimensional properties.
Biological safety testing: Ensuring biocompatibility and effective sterilization.
Functional performance testing: Demonstrating the device performs its intended function (e.g., ultrasound imaging capability) identically to the original device.
Regulatory standards and guidelines: Adherence to established FDA regulations for reprocessing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for an AI/ML model.

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