(30 days)
The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.
The Modified Radius Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
The provided text describes a 510(k) premarket notification for a medical device, the Modified Radius Cougar Wire. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria in the typical sense of AI/software performance.
Therefore, many of the requested points regarding AI device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission. This is a submission for a physical medical device (guidewire) and its performance is evaluated through in vitro (bench) testing, not through analysis of images or other data by an AI algorithm.
Here's an interpretation of the requested information based on the provided text, acknowledging the differences in context:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide explicit numerical "acceptance criteria" in the format of a typical acceptance test specification (e.g., "Accuracy > 90%"). Instead, it lists performance tests that were conducted to demonstrate that the modified device "meets the minimum requirements that are considered adequate for its intended use" and is "substantially equivalent" to predicate devices. The "reported device performance" is essentially that the device passed these tests.
| Performance Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Meets established standards for PTCA guidewires to ensure structural integrity and prevent breakage during use. | Performed/Passed |
| Accelerated Age Testing | Maintains structural integrity and functional performance after simulated aging, indicative of a reasonable shelf-life. | Performed/Passed |
| Coating Adherence/Integrity | Coating remains intact and functional, reducing friction and ensuring proper device delivery. | Performed/Passed |
| Biocompatibility | Meets established standards for biological safety, demonstrating non-toxicity and non-reactivity with human tissues. | Performed/Passed |
Note: The specific quantitative results or detailed pass/fail criteria for these in vitro tests are not provided in this summary. The 510(k) process relies on demonstrating that these tests were "performed" and the device was found to be "substantially equivalent" rather than publishing raw results in the summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for the Test Set: Not specified in the provided summary. This would typically involve a certain number of guidewire samples for each in vitro test.
- Data Provenance: Not applicable in the context of data used for AI. For a physical device, the "provenance" of test results comes from the manufacturer's internal testing facilities.
- Retrospective or Prospective: Not applicable as these tests are laboratory (in vitro) evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these physical performance tests is determined by specific laboratory measurement techniques and engineering standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling or review for AI datasets.
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 a submission for a physical guidewire, not an AI software device. An MRMC study is completely irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these performance tests is defined by established engineering and material science standards (e.g., ISO standards for tensile strength, biocompatibility standards). For example, a guidewire's tensile strength must meet a certain threshold as measured by a calibrated tensile testing machine.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical device performance testing in this context. The "training" in manufacturing comes from process validation and quality control, not machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.