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The PIGGYBACK wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.

The PiggyBack wire converter is a 0.035" outer-diameter support catheter that is compatible with standard 0.014" guide wires. The shaft has a hydrophilic coating to facilitate ease of advancement into the vasculature. The distal tip of the PiggyBack has a radiopaque marker band. The proximal end of the catheter, which remains outside of the patient, has a locking mechanism that secures the PiggyBack onto the 0.014" guide wire. The PiggyBack is provided in three working lengths: 80 cm, 120 cm, and 145 cm.

The provided text is a 510(k) summary for the Vascular Solutions, Inc. PiggyBack™ wire converter and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for device performance as would be seen for a new technology or higher-risk device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for the PiggyBack™ wire converter does not appear within the provided text. The document states that "Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions." This indicates a reliance on standard engineering and biocompatibility testing rather than a clinical performance study with defined acceptance criteria for efficacy or diagnostic accuracy.

Based on the provided text, the specific information requested cannot be fully extracted for the PiggyBack™ wire converter.

Here's an explanation of what can be inferred or directly stated, and what is missing:

1. A table of acceptance criteria and the reported device performance

• Missing: The document does not provide a table of acceptance criteria or specific reported device performance metrics in terms of efficacy or accuracy. The clearance is based on substantial equivalence.

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

• Missing: There is no mention of a "test set" in the context of clinical performance or data provenance (country of origin, retrospective/prospective). The qualification was likely engineering/bench testing.

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

• Missing: Not applicable, as there's no described "test set" requiring expert ground truth for performance evaluation in the provided text.

4. Adjudication method for the test set

• Missing: Not applicable for the reasons above.

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

• Missing: This device is a medical instrument (wire converter), not an AI/diagnostic imaging device. Therefore, an MRMC study or AI assistance is not relevant to its function and is not mentioned.

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

• Missing: Not applicable, as this is not an algorithm-based device.

7. The type of ground truth used

• Missing: For a device like this, the "ground truth" would relate to successful mechanical function, biocompatibility, and intended use as defined by engineering standards, not clinical outcomes or pathology in a study context. The document mentions "biomaterial assessments and verification testing," which likely served as the basis for performance evaluation against internal standards.

8. The sample size for the training set

• Missing: Not applicable, as this is not a machine learning or AI device.

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

• Missing: Not applicable.

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