(201 days)
The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.
The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered with straight and angled tip configurations in various lengths.
The provided text describes the regulatory submission for the Merit Hydrophilic Guide Wire, asserting its substantial equivalence to a predicate device. However, it does not contain a specific study report with detailed acceptance criteria and reported device performance in the format requested. Instead, it outlines the types of tests performed and the standards referenced to demonstrate safety and efficacy.
Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table specifying distinct acceptance criteria values alongside corresponding reported device performance values for each test. It states that "a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device."
The types of tests successfully completed are listed as:
- Coating Adherence/Integrity
- Catheter Compatibility
- Surface
- Fracture Test
- Flex Test
- Size Designation
- Biocompatibility
- Chemical Characterization
For each of these, the document implies that predefined acceptance criteria were met, but the specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. The document mentions tests were performed but does not specify sample sizes or data provenance.
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)
This information is not applicable as the document describes performance testing of a physical medical device (guide wire) against engineering standards and biocompatibility requirements, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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 information is not applicable. The device is a medical guide wire, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests listed, the "ground truth" would be defined by compliance with established industry standards and guidances, such as ISO 11070 for catheter introducers, ASTM F756 for hemolytic properties, and ISO 10993 for biological evaluation. These standards inherently define the acceptable performance parameters. The document also states that the device was compared to a predicate device (K092303) for various performance attributes, implying that the predicate's established safety and efficacy serve as a benchmark.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this physical device's testing. Machine learning or AI models, which typically use training sets, are not part of this device's evaluation as described.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
In summary:
The document focuses on demonstrating that the modified Merit Hydrophilic Guide Wire is substantially equivalent to its predicate based on a battery of tests against recognized industry standards and guidances. It states that these tests met acceptance criteria, thereby demonstrating the safety and efficacy of the device. However, it does not provide the granular details of these criteria or the test results in a tabular format, nor does it involve elements common to AI device evaluations (like ground truth established by experts, reader studies, or training sets).
§ 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.