(39 days)
The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.
The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.
The provided text describes a 510(k) summary for a medical device, the AMPLATZER TorqVue Exchange System. This is a submission for substantial equivalence to a predicate device, not a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission.
The study described is a device verification study to demonstrate that the AMPLATZER TorqVue Exchange System meets established performance criteria and supports equivalency to a predicate device.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual requirements | Met |
| Performance requirements | Met |
| Compatibility requirements | Met |
| Biocompatibility testing (consistent with ISO 10993-1) | Presented (implied as met, as substantial equivalence was concluded) |
| Sterilization (validated ETO process) | Will continue to be sterilized (implied as met existing standards) |
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: Not specified in the document.
- Data Provenance: Not specified, but typical for device verification is in-house testing by the manufacturer (AGA Medical Corporation, Plymouth, MN, USA). The study is prospective in nature, as it involves testing the device against specific criteria.
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 is not applicable as the study described is a device verification study for a delivery system, not a diagnostic or AI device requiring expert-established ground truth. The "ground truth" here is the established performance criteria for the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The verification testing would involve standardized test methods and measurement, not expert adjudication in the context of diagnostic 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
- No. An MRMC study is not relevant for this type of medical device (catheter delivery system). This device does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm. The "standalone" performance refers to the device's ability to meet its functional and safety requirements independently. The listed "visual, performance and compatibility testing" assesses this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is the established performance criteria and specifications for a catheter delivery system, derived from engineering standards, regulatory requirements, and comparison to the predicate device.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm and does not have a "training set."
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).