(25 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance™ 18LP PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 4.0 French nylon tubing compatible with a 0.018-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the Advance™ 18LP PTA Balloon Catheter. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on studies comparing AI performance to human performance or establishing a new clinical effectiveness claim for a novel technology.
Therefore, the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable to this document. This submission focuses on the physical and material performance of a medical device.
Here's the information that can be extracted or inferred from the provided text, primarily related to the physical device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed on the Advance™ 18LP PTA Dilatation Catheter to assure reliable design and performance. While the specific acceptance criteria (e.g., "burst pressure must be X psi") and the numerical results (e.g., "burst pressure was Y psi") are not explicitly detailed, the document states that these tests were conducted and the device "conforms to the requirements for its use."
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile test | Device maintains structural integrity under specified tension. | Results provide reasonable assurance of reliable design and performance. |
| Balloon inflation/deflation test | Balloon inflates and deflates as intended. | Results provide reasonable assurance of reliable design and performance. |
| Balloon burst test | Balloon withstands specified pressure without bursting prematurely. | Results provide reasonable assurance of reliable design and performance. |
| Balloon compliance test | Balloon expands to its intended diameter at specified pressures. | Results provide reasonable assurance of reliable design and performance. |
| Balloon fatigue test | Balloon withstands repeated inflation/deflation cycles without failure. | Results provide reasonable assurance of reliable design and performance. |
| Balloon profile test | Balloon maintains low profile for ease of insertion. | Results provide reasonable assurance of reliable design and performance. |
| Bond strengths test | Components (e.g., balloon to shaft) have adequate bond strength. | Results provide reasonable assurance of reliable design and performance. |
| Shelf life test | Device maintains performance characteristics over its shelf life. | Results provide reasonable assurance of reliable design and performance. |
| Sterility test | Device remains sterile. | Results provide reasonable assurance of reliable design and performance. |
| Sheath compatibility test | Device is compatible with target introducer sheaths. | Results provide reasonable assurance of reliable design and performance. |
| Biocompatibility test | Device materials are safe for human contact. | Results provide reasonable assurance of reliable design and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the physical tests listed (e.g., how many balloons were burst tested). It also does not mention any human-involved "test set" in the context of clinical or AI performance. The data provenance is Cook Incorporated's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The "ground truth" for these physical tests would be objective measurements and adherence to engineering specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not Applicable. No adjudication method is relevant for these physical engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the substantial equivalence of a physical medical device (a catheter) and its engineering performance, not a software device involving AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering specifications, material science principles, and regulatory standards for medical device safety and efficacy. For example, the ground truth for the burst test is the scientifically determined pressure at which the balloon should rupture.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI algorithm, 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 for an AI algorithm, this question is not relevant.
§ 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).