(112 days)
To facilitate the placement of devices during diagnostic or interventional procedures.
NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.
This document is a 510(k) Summary for the Neometrics Spring Coil Guidewire (K143135). It demonstrates substantial equivalence to a predicate device, focusing on bench testing rather than clinical study data relevant to AI/algorithm performance. Therefore, I cannot provide a detailed answer to your request as it pertains to AI/algorithm acceptance criteria and studies.
Based on the provided document, here's what can be extracted and why the rest cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Dimensional Verification | Met requirements |
| Tensile Strength | Met requirements |
| Tip Flexibility | Met requirements |
| Packaging Study | Met requirements |
| Kink Resistance | Met requirements |
| Fracture Resistance | Met requirements |
| Flex Resistance | Met requirements |
| Corrosion Resistance | Met requirements |
| Biocompatibility Testing | Met requirements |
| Radiopacity Testing | Met requirements |
Explanation: The document states, "To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances." It then lists the types of performance tests conducted. While specific numerical acceptance criteria and detailed performance results are not provided in this summary, the conclusion states that "These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate." implying all tests met their respective acceptance criteria.
The following questions cannot be answered from the provided document because it describes a traditional medical device (a guidewire) and its premarket notification, which relies on bench testing and substantial equivalence to a predicate, not an AI/algorithm-based device and its associated clinical/performance studies.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable, as this is bench testing of physical device properties, not a study on an algorithm with a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) - Not applicable. Ground truth for a physical guidewire is established through objective measurements and material science standards during bench testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for bench testing.
- 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 - Not applicable as this is not an AI-assisted device or an imaging/diagnostic device involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable as this is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - For bench testing, ground truth is based on engineering specifications, material standards, and physical measurements.
- 8. The sample size for the training set - Not applicable, as there is no AI algorithm being trained.
- 9. How the ground truth for the training set was established - Not applicable, as there is no AI algorithm being trained.
§ 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.