(27 days)
The CAPERE® Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of an 12Fr Delivery Catheter and 15Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes the 510(k) premarket notification for the CAPERE® Thrombectomy System, focusing on its substantial equivalence to a predicate device (K180722). However, it does not contain a specific acceptance criteria table with reported device performance metrics in the format requested.
The document primarily discusses the nonclinical performance testing conducted to support substantial equivalence. It does not detail a clinical study with human patients for AI/device performance evaluation as implied by some of the questions (e.g., MRMC studies, standalone algorithm performance, AI improvement for human readers). The device described is a medical device for thrombectomy, not an AI/ML algorithm requiring ground truth from experts or large datasets for training and testing in the typical sense of AI product evaluation.
Based on the provided information, I can answer the following:
1. A table of acceptance criteria and the reported device performance
The document states that "the CAPERE® Thrombectomy System functioned as intended under the previously established test methods" and "demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics." It also mentions "preestablished acceptance criteria" but without listing them explicitly or providing specific numerical results.
However, based on the descriptions of the tests, we can infer some of the implicit acceptance criteria:
| Acceptance Criteria Category | Reported Device Performance (Implicitly Met) |
|---|---|
| Biocompatibility | No differences in materials between subject and predicate device; confirmed biocompatibility. |
| Packaging | Packaging capable of maintaining a sterile barrier and protecting the device after sterilization, simulated handling/shipping, environmental conditioning, and accelerated aging for a 6-month shelf-life. |
| Functional Bench Testing | Compliance with relevant standards (ISO 10555-1 and ISO 594-2) for bond joints; maintained predicate characteristics despite reduced diameter. |
| Simulated Use Testing | Simulated clot retrieved under simulated conditions without capture basket rupture, catheter damage, or other adverse device effect; maintained predicate characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes nonclinical performance testing (bench and simulated use testing) rather than a clinical study with human patient data. Therefore, the concept of a "test set" and "data provenance" in the context of human data is not directly applicable here. The testing involved device components and simulated clots. No information is provided regarding the specific number of devices or simulated clots used for each test.
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)
This question is not applicable. The study described is nonclinical performance testing of a physical medical device, not an AI algorithm evaluated against expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There was no clinical study with expert readers requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The CAPERE® Thrombectomy System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical performance tests would be defined by the engineering and quality standards for device functionality. For example:
- Biocompatibility: Confirmation against established biological safety standards.
- Packaging: Ability to maintain sterility and physical integrity as per accelerated aging and handling protocols.
- Functional Bench Testing: Compliance with ISO standards (e.g., ISO 10555-1 for sterile single-use catheters, ISO 594-2 for conical fittings) and maintenance of mechanical characteristics (e.g., bond strength, dimension).
- Simulated Use Testing: Successful retrieval of simulated clots without device failure (rupture, damage) as per predefined criteria.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" for an AI algorithm. The studies are nonclinical performance tests of a physical device.
9. How the ground truth for the training set was established
This question is not applicable.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).