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The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.

The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

The provided document is a 510(k) premarket notification for a guiding catheter, and it does not contain the level of detail typically found in a clinical study report or a performance study. Guiding catheters are Class II devices, and their 510(k) clearances often rely on demonstrating substantial equivalence to a predicate device rather than extensive new clinical trials with detailed performance metrics.

Based on the provided text, here's an analysis of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:
   The document does not report specific quantitative acceptance criteria or detailed device performance data against such criteria. The clearance is based on substantial equivalence. It notes "All appropriate biocompatibility tests for the guiding catheters were successfully completed" but doesn't provide the criteria for "appropriate" or the specific results. The summary states, "The Cordis Guiding Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters," implying that its performance is presumed to be similar to its predicates without presenting new direct performance measurements in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not mention any specific test set, sample size for testing, or data provenance related to a performance study. The 510(k) process for this type of device often relies on engineering bench testing, biocompatibility testing, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients.

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):
   The document does not describe any expert-based ground truth establishment, as it doesn't detail a clinical study where such ground truth would be necessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no described test set requiring adjudication is present.

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:
   Not applicable. This device is a physical medical instrument (guiding catheter), not an AI diagnostic tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no described clinical study with ground truth data is presented. The "ground truth" for showing substantial equivalence here would be the established safe and effective performance of the predicate devices based on their historical use and regulatory clearances.

8. The sample size for the training set:
   Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
   Not applicable, for the same reason as point 8.

Summary of Information from the Provided Document:

This 510(k) submission for the Cordis Guiding Catheter primarily focuses on demonstrating substantial equivalence to existing predicate devices (Cordis Vista Brite Tip and Cordis Endovascular Systems, ENVOY Guiding Catheters). The pathway for clearance relies on showing that the new device has similar design, construction, indications for use, and performance characteristics to legally marketed devices.

The key points from the document regarding performance and acceptance are:

• Biocompatibility: "All appropriate biocompatibility tests for the guiding catheters were successfully completed." (Specific criteria or results are not provided.)
• Substantial Equivalence: The device's "performance characteristics" are deemed "similar" to predicate devices, which implies that the predicate devices' established safety and efficacy serve as the "acceptance criteria" through comparison. No new, independent performance study with defined criteria and measurements is detailed in this summary.

In essence, for this type of medical device 510(k), the "study that proves the device meets the acceptance criteria" is often the comprehensive comparison to predicate devices, supported by bench testing and biocompatibility data. Detailed clinical performance criteria, as might be seen for a novel diagnostic or therapeutic device, are not typically part of this type of submission summary.

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Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems. ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY and Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

This looks like a 510(k) premarket notification for a medical device (Cordis Guiding Catheters) and not a study describing a device that uses AI or machine learning. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML performance evaluations, are not present in the provided text.

The provided text focuses on:

• General Provisions: Common and proprietary names, predicate devices, classification, and lack of established performance standards.
• Indication For Use and Device Description: Explaining what the catheters are used for and their physical characteristics.
• Biocompatibility: Stating that tests were successfully completed.
• Summary of Substantial Equivalence: Claiming similarity to existing devices.
• Proposed Labeling: Discussing package labels, instructions for use, and intended use statements.

Conclusion:

Based on the provided document, I cannot extract the information required to populate the table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML. This document pertains to a traditional medical device submission (catheters) where performance is likely demonstrated through substantial equivalence to predicate devices and adherence to manufacturing and materials standards, rather than through complex performance metrics against a defined ground truth as would be the case for an AI algorithm.

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