Search Results

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.

Ask a specific question about this device

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

Study Details

The primary study referenced for demonstrating acceptance criteria is "Cerebral Protection in Transcatheter Aortic Valve Replacement – The SENTINEL Study."

2. Sample Size and Data Provenance

• Test Set (Clinical Study):
  • Randomized Cohort: 363 patients (123 in Safety Arm, 121 in Test Arm, 119 in Control Arm).
  • Roll-in Patients: 65 additional non-randomized patients.
  • Data Provenance: Prospective, multi-center, randomized study conducted at 19 centers in the United States and Germany.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Clinical Events Committee (CEC): Remained blinded throughout the trial and adjudicated all Major Adverse Cardiac and Cerebrovascular Events (MACCE) endpoints. The qualifications of these experts are not explicitly detailed beyond being a "Clinical Events Committee."
• Independent Blinded MRI Core Lab: Analyzed all MRI endpoint data. Qualifications are not explicitly detailed.
• Independent Blinded Neurocognitive Core Lab: Analyzed all neurocognitive endpoint data. Qualifications are not explicitly detailed.

4. Adjudication Method (Test Set)

• Clinical Events Committee (CEC): The text states that the CEC "adjudicated all Major Adverse Cardiac and Cerebrovascular Events (MACCE) endpoints." This implies an expert review and final decision on these events. The specific method (e.g., 2+1, 3+1) is not explicitly stated, but it was a blinded process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. The SENTINEL study was a clinical trial comparing a device intervention (Sentinel System) to standard of care (TAVR only), not an AI efficacy study.
• Therefore, no effect size for human readers improving with vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

• The Sentinel® Cerebral Protection System does not contain software and is a physical medical device. Therefore, a standalone (algorithm only) performance study was not applicable and not performed.

7. Type of Ground Truth Used (Clinical Study)

• Clinical Endpoints: MACCE (death, stroke, Class 3 AKI) were adjudicated by a blinded Clinical Events Committee. This represents expert consensus based on clinical data.
• Imaging Endpoints: DW-MRI lesion volumes were analyzed by an independent blinded MRI core lab. This also relies on expert interpretation of imaging data.
• Neurocognitive Endpoints: Neurocognitive evaluations were analyzed by an independent blinded neurocognitive core lab. This relies on expert assessment of neurocognitive test battery results.
• Captured Debris Histopathology: For the Test Arm, captured debris underwent histopathology. This is pathology ground truth for the presence and nature of embolic material.

8. Sample Size for the Training Set

• The Sentinel system is a physical device and does not involve a "training set" in the context of machine learning. The "training" for the device would be the rigorous bench, animal, and early human use (roll-in patients) studies.
• The roll-in patients (65 subjects) could be considered a form of early clinical "training" or experience-building for the sites and procedures, but they were explicitly non-randomized and separate from the primary effectiveness analysis.

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

• As the device does not employ machine learning, there is no "training set" ground truth in that sense.
• For the non-clinical and animal studies which demonstrate the device's fundamental performance (analogous to foundational data for a conventional device), the "ground truth" was established through:
  • Bench Testing: Engineering specifications and direct measurements against those specifications.
  • Animal Studies: Direct observation of device performance in in vivo conditions, gross pathology, and histopathology. These informed design improvements and verified safety and fundamental function before the pivotal human clinical trial.

Ask a specific question about this device