(56 days)
The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
The Modified Concentric Retriever consists of a flexible, tapered core wire with five The Nically-shaped helical loops at the distal end. Polymer filaments are fastened to the helix to aid in the entrapment and retrieval of foreign bodies. A radiopaque coil is attached over the distal end to facilitate fluoroscopic visualization. The device is covered with a hydrophilic coating to reduce friction during use. A visible marker on the Retriever wroximal end aids the physician in determining when the Retriever tip is about to exit the Microcatheter tip. The device is provided with an insertion tool to facilitate introduction into a Microcatheter and a torque device to facilitate manipulation. The Modified Coocentric Retriever is delivered to the treatment site using a compatible Microcatheter as specified in the Instructions for Use.
The provided text is a 510(k) summary for the Concentric Medical, Inc. Modified Concentric Retriever. It is a premarket notification to the FDA for a medical device. This type of document focuses on establishing substantial equivalence to a predicate device and demonstrating safety and effectiveness based on non-clinical performance and functional testing, not typically on extensive clinical studies as would be required for a novel device or a higher-risk classification.
Therefore, the information requested in your query, particularly regarding clinical study details like acceptance criteria measured against patient outcomes, sample sizes for test and training sets, expert adjudication, and MRMC studies, is not present in this 510(k) summary. These summaries generally do not include such detailed clinical study information because they rely on performance data and a comparison to an already-approved device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria for the device are not detailed in this summary. It generally states that the device passed all tests. | The Modified Concentric Retriever has successfully passed all performance and functional testing performed, demonstrating that the device performs in accordance with the requirements of the Product Specification. (Detailed results are not provided.) |
Missing: Specific quantitative performance criteria (e.g., tensile strength, retrieval efficiency, etc.) and their measured values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing: This 510(k) summary mentions "performance and functional testing" but does not specify a "test set" in the context of clinical data or patient samples. The testing described appears to be benchtop or non-clinical. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective in a clinical sense.
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)
Missing: No information regarding experts or ground truth establishment in a clinical context is provided. The testing described is non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing: No information on adjudication is provided as the summary does not detail clinical study results or expert interpretation.
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
Missing: No MRMC or AI-assisted studies are mentioned. This device is a mechanical retriever, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing: This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing: As the testing appears to be non-clinical, there is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data. The "ground truth" for the non-clinical testing would be the predefined product specifications.
8. The sample size for the training set
Missing: No training set information is provided. This type of device does not typically involve training sets in the machine learning sense.
9. How the ground truth for the training set was established
Missing: Not applicable.
Summary of Device and Study Information Present in the Document:
- Device Name: Modified Concentric Retriever
- Intended Use: To remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
- Predicate Device: K040745 Concentric Retriever LX
- Testing Summary: The device "successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification."
- Regulatory Compliance: Designed, developed, and manufactured in accordance with Concentric Quality System which complies with 21 CFR §820.30.
- Substantial Equivalence: Concludes that the Modified Concentric Retriever is substantially equivalent to the legally marketed predicate device.
To obtain the detailed information requested in your prompt, one would typically need to refer to the full 510(k) submission, including specific test reports and protocols, which are usually more extensive than the publicly available 510(k) Summary.
§ 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).