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The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

The Sentinel™ Cerebral Protection System (Sentinel CPS) is a 6 French, 95 cm working length, single use, temporary, percutaneously delivered embolic protection device, inserted into the radial or brachial artery. The system is designed to capture and remove debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel CPS utilizes an embolic filter delivered to the brachiocephalic artery (Proximal Filter) and a second embolic filter delivered to the left common carotid artery (Distal Filter). At the completion of the procedure, the filters and debris are recaptured into the catheter and removed from the patient. The device is provided sterile and is single-use only.

The Sentinel CPS is available with a Proximal Filter size of 15 mm (target vessel size of 9 - 15 mm) and a Distal Filter size of 10 mm (target vessel size of 6.5 - 10 mm).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the exact sample sizes used for the non-clinical performance and biocompatibility tests. It broadly mentions "testing" and "verification and validation activities."

• Data Provenance: The studies are non-clinical (laboratory/in-vitro/animal) and therefore do not involve patient data or geographical provenance in the typical sense of clinical trials. The testing was conducted to assess modifications to a previously cleared device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of study described. The study is a non-clinical assessment of material and functional changes to a medical device. Ground truth, in the context of expert consensus, pathology, or outcomes data, typically refers to clinical trials or diagnostic accuracy studies involving human interpretation or clinical outcomes. Here, the "ground truth" is defined by the technical specifications and performance requirements of the device, assessed through direct measurement and laboratory tests.

4. Adjudication Method for the Test Set

This is not applicable as there are no human interpretations or clinical decisions being made that would require adjudication. The evaluation is based on objective measurements and established test methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance and biocompatibility of a modified device, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. The device (Sentinel Cerebral Protection System) is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on pre-established acceptance criteria derived from engineering specifications, regulatory guidelines (e.g., FDA Guidance, ISO 10993-1), and the performance of the predicate device. These criteria define what constitutes acceptable performance for each test (e.g., specific force ranges, pore sizes, biological response limits).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This is a non-clinical verification and validation study for a physical medical device, not a machine learning model.

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

As the concept of a training set is not applicable, this question is not relevant.

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The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

The Sentinel® Cerebral Protection System (Figure 1) is a 6 French, 95 cm working length, single use, temporary, percutaneously-delivered embolic protection catheter inserted into the right radial or brachial artery. The system is designed to capture and remove embolic material (thrombus/debris) during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel System employs two embolic filters, one delivered to the brachiocephalic artery (Proximal Filter), and one to the left common carotid artery (Distal Filter). The nominal filter diameters are 15 mm (Proximal Filter) and 10 mm (Distal Filter).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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