(29 days)
The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Emboshield NAV6 Embolic Protection System:
This document describes a 510(k) submission for a medical device. It does not contain information about acceptance criteria or a study proving acceptance criteria related to AI/algorithm performance. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing, biocompatibility, sterilization, and aging data.
Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the provided text.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" are implied by successful completion of various performance tests to demonstrate substantial equivalence to predicate devices. There are no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) explicitly stated for the device's emboli capture effectiveness or other clinical outcomes, as this is a traditional medical device, not an AI/software device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Hemocompatibility, etc.) | Successfully completed |
| Simulated Use | Successfully completed |
| Loading/Deployment/Retrieval Forces | Successfully completed |
| Distal Preservation Flow (Flow Characteristics) | Successfully completed |
| Tensile Strength (Filtration Element Strength, Frame Integrity) | Successfully completed |
| Catheter Coating Integrity (Congo Red Test, Particulate Evaluation, Coating Delamination) | Successfully completed |
| Sterilization Validation (Non-pyrogenic) | Successfully completed |
| Shelf Life (2-year Accelerated Aging) | Successfully completed |
| Substantial Equivalence to Predicate Devices | Established - "is as safe, as effective, and performs as well as or better than the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the provided text for any of the performance tests. These are likely bench tests using a number of device units.
- Data provenance: Not specified. Given the nature of the tests (bench, biocompatibility, sterilization, aging), they would typically be conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical medical device, not an AI/imaging device requiring expert ground truth for a test set. The "ground truth" for its performance is determined by established engineering and biological testing methods.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations for a test set.
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
- No. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench test results, biological assays, engineering measurements. The "ground truth" for this device's performance is derived from the objective results of the various performance tests listed (e.g., cytotoxicity assays, tensile strength measurements, flow dynamics, sterility tests).
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).