(181 days)
The HYDROCORE™ Guide Wire is intended to facilitate the placement of diagnostic and therapeutic devices during intravascular procedures
The HYDROCORE™ Guide Wire is a 150 cm length guide wire is available in nominal diameters of 0.025", 0.032", 0.035" and 0.038″, with shaft stiffness variations of: soft, standard, and extra stiff. The wires come in straight and angled tip configurations. The wire is constructed from a stainless steel core wire that is encased in a urethane resin and surfaced with a hydrophilic coating. The urethane casing contains radiopaque properties.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HYDROCORE™ Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Tensile Strength Test | Met acceptance criteria and performed similar to predicate devices. |
| Torque Strength Test | Met acceptance criteria and performed similar to predicate devices. |
| Tip Flexibility Test | Met acceptance criteria and performed similar to predicate devices. |
| Torqueability Test | Met acceptance criteria and performed similar to predicate devices. |
| Coating Adhesion and Integrity Test | Met acceptance criteria and performed similar to predicate devices. |
| No New Safety/Effectiveness Issues | "No new safety or effectiveness issues were raised during the testing program." |
| Substantial Equivalence to Predicate Devices | The device was found to have "similar intended use, and has the same technological characteristics, performance properties, identical sterilization and packaging as those of the predicate devices." Based on bench tests, it was concluded to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "bench testing," implying a set of physical devices were tested, but the number of guide wires used for each test is not provided.
- Data Provenance: The study was a bench test, meaning it was conducted in a laboratory setting, not on patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional clinical trial sense for this type of testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is not applicable to this study. Bench tests rely on objective physical measurements against predefined engineering specifications (acceptance criteria) rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
- None. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth from subjective data. Since this study involved objective bench testing against pre-defined specifications, no human adjudication was required.
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 was a bench test of a medical device (guide wire), not an AI-powered diagnostic tool. Therefore, an MRMC study or any assessment of human reader improvement with AI assistance is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The device is a physical guide wire, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this study was established using predefined engineering specifications and performance characteristics for guide wires. The device's performance in tensile strength, torque strength, tip flexibility, torqueability, and coating adhesion/integrity was measured and compared against these objective criteria and the performance of predicate devices.
8. The Sample Size for the Training Set
- This concept is not applicable to this study. Bench testing of a physical medical device does not involve "training sets" in the context of machine learning or AI models. The device itself is not an algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable for the reasons stated above.
§ 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.