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Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.

The provided text describes a 510(k) premarket notification for the Terumo Support Catheter, which aims to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve the rigorous clinical trials or complex statistical analyses that would be found in a PMA (Premarket Approval) application for novel, high-risk devices. Therefore, many of the requested elements regarding acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for AI/ML devices are not applicable.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise any new questions of safety or effectiveness. This is achieved through a combination of design, materials, specifications, and performance testing, often comparing the new device directly to the predicate.

Here's an attempt to extract and present the information based on the provided document, addressing the requested points where possible, and noting when information is not applicable to this type of submission.

Acceptance Criteria and Device Performance for Terumo Support Catheter

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices across various attributes. The performance tests conducted are to ensure the new device meets specifications comparable to or better than the predicates. The text states:

"The Terumo Support Catheter met all performance specifications."

While specific numerical acceptance criteria for each test (e.g., minimum force at break, maximum allowable leakage) are not explicitly detailed in the provided summary, the overarching acceptance criterion is successful completion of all listed performance tests, demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met all specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of catheters tested) for each performance or biocompatibility test. It indicates that "Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS." This implies a comparison study, but the specific N for each test article is not disclosed.

The "data provenance" mentioned in the context of AI/ML (country of origin, retrospective/prospective) is not applicable here as this is a physical medical device. The data comes from in vitro (laboratory) and in vivo (Thrombogenicity Study in Dogs) testing of device prototypes.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This section is not applicable. The evaluations are based on objective physical, chemical, and biological tests, not expert interpretation of diagnostic images or patient outcomes. The "ground truth" for parameters like "force at break" is a direct measurement, not an expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable, as there's no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is typically relevant for diagnostic imaging AI tools, not for a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence.

6. If a Standalone Performance Study (Algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or AI device. The performance tests evaluate the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., force at break, burst pressure, flow rate, dimensions) is established through direct physical measurements and standardized test methods. For biocompatibility, the ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, hemolysis, pyrogenicity) against established safety thresholds as per ISO-10993. For sterilization, the ground truth is the demonstration of sterility to a specific SAL (Sterility Assurance Level) through validated processes in accordance with relevant ISO standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML model being "trained" for this device. The development process involves design, prototyping, testing, and refinement, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set was Established

This section is not applicable, as there is no training set in the context of this device's development or regulatory submission.

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