(24 days)
The ANGIOGUARD™ XP Emboli Capture Guidewire and the ANGIOGUARD™ RX Emboli Capture Guidewire are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an integrated emboli filter at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of the stents and interventional devices during carotid procedures. The devices are delivered via a deployment sheath and captured via a capture sheath. The ANGIOGUARD devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved. The device is available with filter basket diameters of 4, 5, 6, 7 and 8mm. The ANGIOGUARD devices are intended to capture emboli during carotid stenting procedures.
The provided text describes the ANGIOGUARD™ XP Emboli Capture Guidewire System and the ANGIOGUARD™ RX Emboli Capture Guidewire System. However, it does not include a table of acceptance criteria or a direct study proving the device meets specific numerical criteria. Instead, it demonstrates substantial equivalence to predicate devices and presents clinical trial outcomes for safety and effectiveness.
Here’s the information based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for the device's performance in preventing emboli capture or reducing adverse events. Instead, it highlights the device's performance through a non-inferiority study against a surgical alternative.
| Performance Metric | Acceptance Criteria (Implicit from Non-inferiority) | Reported Device Performance (ANGIOGUARD Stent Group) |
|---|---|---|
| Incidence of death, stroke, or MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in randomized arm | Non-inferiority to surgical group (Carotid Endarterectomy - CEA) within a 3% delta. | 12.0% (20/167) |
| Non-inferiority difference (Stent vs. CEA) | The difference needed to be within a 3% delta to show non-inferiority of the stent arm. | -7.2% ({14.9%, 0.6)}, indicating the upper bound of the 95% CI for the difference was below the 3% non-inferiority margin, thus establishing non-inferiority. |
| Incidence of death, stroke and MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in the Registry Study Arm | Not explicitly defined against a numerical acceptance criterion in the text, but tested against an "OPC" (Optimal Performance Criterion), with varying p-values. | 15.8% (64/406) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Randomized Arm: 334 subjects (167 in the stent group and 167 in the CEA group).
- Non-randomized Stent Arm: 406 subjects.
- Non-randomized Surgical Arm: 7 subjects.
- Overall Total: 747 patients.
- Data Provenance: The clinical evaluation was a multi-center, randomized study (SAPPHIRE) conducted at 29 investigative sites in the United States. This indicates a prospective, multi-center US study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical endpoints (death, stroke, MI). Clinical endpoints like death and MI are typically determined by clinical event committees or adjudicated by qualified medical professionals, but specifics are missing here.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) for the clinical endpoints. However, in major clinical trials like SAPPHIRE, it is standard practice to have an independent Clinical Events Committee (CEC) adjudicate events to ensure consistency and minimize bias.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a physical medical device (guidewire with an embolic filter) and not an imaging or diagnostic AI-powered tool that would typically involve human readers interpreting cases. The study compared the device (in conjunction with stenting) against surgical intervention (Carotid Endarterectomy).
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in a sense, a "standalone" performance was assessed for the device itself through:
- In-vitro testing: dimensional, tensile/torque testing, and functional testing.
- Biocompatibility, sterilization qualification, residual analysis, packaging testing, product shelf-life testing.
- Functional testing in animal models (porcine models): used to evaluate device performance and demonstrate satisfactory characteristics.
- Emboli capture and vessel damage studies utilizing an earlier version of the ANGIOGUARD device, showing satisfactory results with no significant luminal disruption or hemolysis.
These tests evaluate the device's physical and functional properties independent of human decision-making in real-time, focusing on its design and material integrity in performing its intended function.
7. Type of Ground Truth Used
The ground truth used in the clinical study was based on clinical outcomes data (death, stroke, MI) and ipsilateral stroke at specific time points, as adjudicated by medical professionals based on established definitions.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI model, as this is a physical medical device. The "training data" for the device's design and preclinical evaluation would implicitly be the various in-vitro tests and animal models used during its development. If we interpret "training set" as the data that informed the device's development or initial design, then the preclinical data (in-vitro, animal studies) served this purpose. No specific "sample size" is applicable in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Given that this is a physical medical device and not an AI/ML algorithm, the concept of "ground truth for the training set" as it relates to expert annotation or consensus is not directly applicable.
- The "truth" for the in-vitro tests was based on engineering specifications and physical measurements.
- For animal models, the "truth" was established through direct observation, physiological measurements, and histological analysis (e.g., for luminal disruption or hemolysis) in the porcine arteries after device deployment and retrieval. Pathological assessment would likely be the ground truth method in such cases. The document states these demonstrated "satisfactory device performance characteristics."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).