(29 days)
The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm. This Special 510(k) provides for the use of CBAS® heparin coating on the device.
The provided text focuses on the GORE® Embolic Filter's 510(k) summary, which details its substantial equivalence to predicate devices. It describes the device, its intended use, and the performance data used to support its equivalence. However, it does not provide specific quantitative acceptance criteria or a detailed study proving the device meets those criteria in the way a clinical study report would.
The information primarily discusses types of testing performed rather than specific results or predefined acceptance thresholds.
Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document in the format of a table with specific quantitative acceptance criteria and corresponding reported device performance values. The text describes types of tests performed to demonstrate substantial equivalence, but not the specific numerical targets or results of these tests against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Again, this information is not explicitly provided in the document. The text mentions "Animal: Animal studies were conducted to evaluate the performance of the CBAS® heparin coating," but does not specify the number of animals used or the design of these studies (e.g., retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes non-clinical and animal studies, not a study involving human interpretation or expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not mentioned or indicated. The document focuses on demonstrating substantial equivalence through non-clinical and animal testing, not through human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is a physical medical device (embolic filter), not an AI algorithm. The performance evaluation is related to its mechanical and biological characteristics.
7. Type of Ground Truth Used
Based on the description of testing, the "ground truth" was established through:
- Biocompatibility testing: Standardized laboratory assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility, LAL endotoxin test).
- Non-Clinical System Tests: Evaluation of loading, deployment, and retrieval forces.
- Filter Component Tests: Evaluation of filter efficiency, heparin concentration, hydrophilicity, residuals, and elution.
- Animal Studies: In vivo evaluation of CBAS® heparin coating performance.
Essentially, the ground truth was established by direct measurement and observation in controlled laboratory and animal environments according to established protocols for medical device testing.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
In summary, the provided text describes a 510(k) submission focused on demonstrating substantial equivalence for a physical medical device (GORE® Embolic Filter). The document outlines various types of performance testing (biocompatibility, mechanical, animal studies) but does not provide the quantitative details of acceptance criteria or the specific results of these studies against those criteria, nor does it describe studies involving human readers, AI, or specific statistical evaluations of diagnostic performance.
§ 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).