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The Guidant Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

The RAPIDO Guiding Catheters are available in two French sizes (6F and 8F). The 6F RAPIDO Guiding Catheter has a standard working length of 69 cm. The 8F RAPIDO Guiding Catheter has as standard working length of 47 cm.

The provided text is a 510(k) summary for the RAPIDO™ Guiding Catheter. This type of regulatory document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance data. It does not contain the kind of detailed information requested about clinical study design, specific acceptance criteria for performance metrics, ground truth establishment, or human-AI interaction studies.

Therefore, for many of your questions, the answer will be that the information is not provided in the given text.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The summary only says "Testing demonstrated that the 6F/8F RAPIDO Guiding Catheters met the acceptance criteria." The specific criteria (e.g., burst pressure, tensile strength, flow rate thresholds) are not listed.
• Reported Device Performance: Not explicitly stated in quantitative terms. The summary says "performed similarly to the predicate device (EASYTRAK Guiding Catheter)." No numerical performance metrics are given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely refers to bench testing data rather than patient data given the device type and 510(k) context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a guiding catheter, not an AI diagnostic tool that relies on expert interpretation for ground truth in a clinical study. The performance data would generally come from engineering bench tests (e.g., mechanical, material, fluid dynamics).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As above, this concept applies to studies where human interpreters (or AI outputs) are being adjudicated, not to physical device performance 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 not an AI diagnostic device. No MRMC study or human-in-the-loop AI performance evaluation would have been conducted or reported for this type of medical device.

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

• No. This is not an AI algorithm. Its performance is evaluated through physical and mechanical testing, not as an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not specified in this context. For a medical device like a catheter, "ground truth" refers to established engineering standards, material specifications, and validated test methods (e.g., for burst pressure, flexibility, lubricity). The 510(k) summary does not detail these specific "ground truths."

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a "training set."

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

• Not applicable. As above, this is not an AI device.

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