(22 days)
The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.
The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.
The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.
The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.
The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® 3 Delivery Sheath. This document primarily focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical study data involving human performance or specific acceptance criteria for a diagnostic AI device.
Therefore, the requested information, which is typically associated with AI/ML diagnostic device studies, cannot be fully extracted or is not applicable in this context.
Here's an attempt to answer based on the provided text, highlighting where the information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria or specific numerical performance metrics for a diagnostic device. Instead, it states that the functional characteristics were determined to be "substantially equivalent" to predicate devices. The bench tests are described generally.
| Acceptance Criteria (Not Explicitly Stated as Numerical Criteria) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| Visual and dimensional integrity | Met, as part of substantial equivalence |
| Resistance to kinking (due to torque and bending) | Met, as part of substantial equivalence |
| Freedom from leakage of air and liquid | Met, as part of substantial equivalence |
| Tensile strength | Met, as part of substantial equivalence |
| Device interaction testing | Met, as part of substantial equivalence |
| Distribution simulation (at baseline and after 3-year accelerated aging) | Met, as part of substantial equivalence |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench testing" which typically involves a small, representative sample of devices for engineering tests, not a large clinical test set.
- Data Provenance: Not applicable. The data is from laboratory (bench) testing of the device itself, not from clinical data (e.g., patient records, images).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a delivery sheath, not a diagnostic device requiring expert review for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or diagnostic decision-making involved in the bench testing described.
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. This is not an AI/ML diagnostic device, and no MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm; it is a physical medical device.
7. The type of ground truth used
The "ground truth" for this device's evaluation is based on engineering specifications, material properties, and functional performance benchmarks (e.g., resistance to kinking, tensile strength, leakage) as determined through bench testing. It's not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and prior regulatory approvals of similar predicate devices.
§ 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).