(29 days)
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system 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 in straight and angled configurations in various lengths.
The provided text does not describe a study involving an AI/algorithmic device. The document is a 510(k) premarket notification for a Merit Hydrophilic Guide Wire, which is a physical medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.
The document discusses the substantial equivalence of the subject guide wire to predicate devices based on various performance attributes and safety tests.
Here's a breakdown of what is provided, as it relates to the physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of specific acceptance criteria values and corresponding device performance data for each test. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "As all test results were comparable to the predicate devices and the subject Merit Hydrophilic guide wire met the predetermined acceptance criteria applicable to the safety and efficacy of the device, this has demonstrated the subject device is substantially equivalent to predicate devices." |
Tests Performed (implied acceptance criteria for each):
- Tensile Strength
- Torque Strength
- Torquability
- Tip Flexibility
- Coating Adherence/Integrity (including Evaluation using Anatomical Model)
- Catheter Compatibility (Durability)
- Surface
- Fracture Test
- Flex test
- Size Designation/Dimensions
- Radiopacity
The acceptance criteria for these tests were based on:
- FDA guidance: Coronary and Cerebrovascular Guide Wire Guidance January 1995.
- ISO 11070: 1998, Sterile Single-Use Intravascular Catheter Introducers.
- ISO 11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
2. Sample size used for the test set and the data provenance
Not applicable for an AI device. For the physical guide wire, the sample sizes for each specific test (e.g., tensile strength, flex test) are not explicitly stated in this summary. The tests were likely conducted on a sufficient number of samples to statistically demonstrate compliance with the acceptance criteria, as is standard practice for medical device testing. The provenance of the "data" (i.e., the physical test results) would be from in-house laboratory testing conducted by Merit Medical Systems, Inc. in Ireland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on medical images) does not apply to the performance testing of a physical guide wire. The "ground truth" for these tests would be the established engineering and biological standards and guidances mentioned above.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving disagreements among multiple human readers in image interpretation, which is not relevant to this physical device.
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 irrelevant to a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is irrelevant to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical device, the "ground truth" refers to the established scientific and engineering principles, material properties, and biological safety standards (e.g., biocompatibility standards like ISO 10993) against which the device's performance was measured. There's no "ground truth" in the AI sense.
8. The sample size for the training set
No. This is irrelevant to a physical medical device.
9. How the ground truth for the training set was established
No. This is irrelevant to a physical medical device.
§ 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.