(35 days)
The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.
The FiberNet Embolic Protection System consists of a fiber filter on a 0.014" guide wire with attachable actuator tool and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer and a 40µm cell strainer cup.
The provided text describes a 510(k) summary for the FiberNet® Embolic Protection System. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility analysis, rather than setting specific performance acceptance criteria for a new clinical study or providing detailed results from such a study.
Therefore, many of the requested points regarding acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), and ground truth establishment for a new device performance study cannot be directly extracted from this document as it details a regulatory submission based on equivalence testing.
However, I can provide the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for each bench test, nor does it provide numerical results. Instead, it asserts that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Wall integrity/aspiration rate equivalent to predicate | Met (Equivalent to predicate device) |
| Push/track equivalent to predicate | Met (Equivalent to predicate device) |
| Stent crossing equivalent to predicate | Met (Equivalent to predicate device) |
| Torque response equivalent to predicate | Met (Equivalent to predicate device) |
| Tip stiffness equivalent to predicate | Met (Equivalent to predicate device) |
| Torque strength equivalent to predicate | Met (Equivalent to predicate device) |
| Liquid leakage under aspiration equivalent to predicate | Met (Equivalent to predicate device) |
| Liquid leakage pressure hub/catheter equivalent to predicate | Met (Equivalent to predicate device) |
| Kink resistance equivalent to predicate | Met (Equivalent to predicate device) |
| Tensile bonds and joints (catheter port and hub) equivalent to predicate | Met (Equivalent to predicate device) |
| Device retraction equivalent to predicate | Met (Equivalent to predicate device) |
| Biocompatibility equivalent to predicate (Cytotoxicity, Hemolysis, Complement Activation, Unactivated Partial Thromboplastin Time Assay, In vivo Thrombogenicity, Physical Chemical) | Met (Equivalent to predicate device, supported by material manufacturer data and additional tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document describes a pre-market submission based on bench testing and biocompatibility to establish substantial equivalence. It does not involve a clinical test set with human patients. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This was bench and biocompatibility testing, not human-read clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This was bench and biocompatibility testing, not human-read clinical data.
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:
Not applicable. This document is for an embolic protection system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device that physically captures embolic material, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench testing, the "ground truth" would be established by standardized engineering measurements and defined performance specifications, often relative to the predicate device. For biocompatibility testing, the ground truth is established by recognized standards and scientific principles for assessing biological responses to materials.
8. The sample size for the training set:
Not applicable. This document describes testing for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
§ 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).