(59 days)
The HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.
The HydraView Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 30cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support; ES, DS and EDS.
The provided text is a 510(k) summary for the HydraView Polymer Guidewire and contains information about its equivalence to predicate devices based on non-clinical performance testing. It is not a study proving a device meets acceptance criteria related to an AI algorithm or diagnostic performance. Therefore, I cannot extract the specific information requested in your prompt regarding AI performance, human readers, ground truth establishment, or sample sizes for AI training/test sets.
However, I can extract information related to the non-clinical performance testing for the HydraView Polymer Guidewire, which serves as the "study" in this context to demonstrate substantial equivalence to its predicate devices.
Here's an interpretation of the available information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that in-vitro bench tests were carried out to demonstrate equivalence. While explicit acceptance criteria and specific numerical reported performance values are not detailed in this summary, the following table lists the tests performed, implying that the acceptance criterion for each was "comparable to predicate devices" or "conformance to requirements for intended use." The reported performance is that the device met these implied criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional Verification (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Tensile Strength (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Torque strength (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Torque response/Torqueability (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Coating adherence/Integrity (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Catheter/Lead compatibility (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Tip Stiffness (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Biocompatibility testing (passed and comparable to predicate) | Materials are identical to predicate Charter Guidewire and successful use in other 510(k) approved products. Safety established. |
| Radiopacity testing (comparable to predicate) | Demonstrated equivalence to predicate and conformance to requirements. |
| Particulate Testing (comparable to predicate, within limits) | Demonstrated equivalence to predicate and conformance to requirements. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench testing of a medical device, not an AI algorithm. Therefore, "test set" and "data provenance" in the context of clinical data are not applicable. The evaluations were in-vitro (bench tests). The sample sizes for each specific bench test (e.g., number of guidewires tested for tensile strength) are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is for AI algorithm validation, which is not described here. For mechanical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and comparison against established predicate device performance. Experts would be involved in designing and executing the tests and interpreting the engineering data, but their "number" and "qualifications" in the sense of clinical ground truth establishment are not relevant or provided.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This is for clinical data adjudication in AI studies and is not applicable to 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
This is for AI algorithm clinical studies and is not applicable to the bench testing described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is for AI algorithm performance and is not applicable to the bench testing described.
7. The Type of Ground Truth Used
For this device, the "ground truth" is based on:
- Engineering Specifications and Performance Standards: The tests were conducted "with reference to the FDA's guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'."
- Predicate Device Performance: The primary comparison for demonstrating substantial equivalence was against the performance of the Streamer Guidewire and Charter Guidewire (predicate devices). This means the established, safe, and effective performance of the predicate devices served as the benchmark.
8. The Sample Size for the Training Set
This is for AI algorithms and is not applicable to the bench testing described.
9. How the Ground Truth for the Training Set Was Established
This is for AI algorithms and is not applicable to the bench testing described.
§ 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.