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CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.

CES Vascular Occlusion System (occlusion device and coil pusher)

This document is a Premarket Notification 510(k) for the Cordis Corporation CES Vascular Occlusion System, submitted in 1997. It is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• General provisions (common/proprietary names, classification).
• Identification of predicate devices for substantial equivalence.
• Intended use and device description.
• Biocompatibility testing (stated as successfully performed, but no details of the tests or results are provided).
• Summary of substantial equivalence to predicate devices based on design, construction, indication for use, and performance characteristics (again, without detailed performance studies).

Therefore, I cannot provide the requested information in the table format because the source document does not contain any of the following:

• 1. A table of acceptance criteria and the reported device performance: This document is a summary of safety and effectiveness based on substantial equivalence to predicate devices, not a report of a specific clinical performance study with predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: No performance test set is described.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported in this document.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used: Not applicable as no detailed performance study is presented.
• 8. The sample size for the training set: Not applicable as no machine learning algorithm is involved.
• 9. How the ground truth for the training set was established: Not applicable.

The document states that "All appropriate biocompatibility tests were successfully performed on the CES Occlusion System," but it does not detail these tests, their acceptance criteria, or the specific results. The basis for clearance is "Summary of Substantial Equivalence," meaning the device is considered as safe and effective as previously cleared predicate devices, rather than through a new, specific performance study against defined criteria.

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The ESSENCE™ Guidewires are intendedfor the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The mid value a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.

The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.

This document is a Premarket Notification 510(k) for the Cordis Endovascular Systems, Inc. ESSENCE™ Stainless Steel Guidewire, submitted in 1995.

Based on the provided text, the device falls under a different regulatory pathway (510(k) Pre-market Notification for a guidewire in 1995) than a typical AI/ML-based medical device. Therefore, the information requested in the prompt, which is standard for AI/ML device studies, is largely not applicable to this specific document.

Here's an analysis based on the available text:

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

   • Not Applicable. This document is a 510(k) summary for a guidewire, not an AI/ML diagnostic or therapeutic device. It does not contain specific acceptance criteria with reported performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). The summary states, "The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires." This implies equivalence to predicate devices rather than meeting quantitative performance targets.

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

   • Not Applicable. The document does not describe a clinical study or a test set as would be relevant for an AI/ML device. It focuses on device design, materials, and equivalence to existing devices.

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. Ground truth establishment by experts is not a component of this type of device submission.

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

   • Not Applicable. Adjudication methods are not described for guidewire submissions like this.

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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would have been performed or reported.

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

   • Not Applicable. This is a physical medical device (guidewire), not an algorithm.

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

   • Not Applicable. The concept of "ground truth" as used in AI/ML performance evaluation does not apply to this guidewire submission. The evaluation would have been based on material properties, mechanical testing, and biocompatibility, as indicated in Section VI.

8. The sample size for the training set

   • Not Applicable. There is no training set required for this type of device.

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

   • Not Applicable. No training set or associated ground truth establishment.

In summary, the provided document pertains to a 510(k) Pre-market Notification for a conventional medical device (a guidewire) from 1995. The framework for describing AI/ML device studies, including acceptance criteria, sample sizes, and ground truth methodologies, is not relevant to this historical submission.

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