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510(k) Data Aggregation
(88 days)
The HI-TORQUE STEELCORE™18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
The HI-TORQUE STEELCORE™ 18 Guide Wire is a steerable guide wire with a nominal diameter of 0.018 inches and three lengths: a 130 cm, a 190 cm and a 300 cm exchange length.
The provided text describes the performance testing for the HI-TORQUE STEELCORE™ 18 Guide Wire.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Distal Tip Pull Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Turns-to-Failure Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Rotational Accuracy Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Tip Flexibility Test | Met acceptance criteria and performed similar to predicate guide wires. |
2. Sample size used for the test set and the data provenance:
The document mentions "bench testing" but does not specify the sample size for the test sets used for each test. Furthermore, there is no information provided regarding the country of origin of the data or whether the tests were retrospective or prospective. Given that this is bench testing, it is generally considered prospective, as the tests are conducted for the specific purpose of evaluating the device.
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. The performance data is based on physical bench tests, not on expert interpretations of medical images or data requiring ground truth established by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not in physical 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:
This information is not applicable. This device is a guide wire, and the study involves bench testing of its physical properties, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a medical instrument, not an algorithm. The "standalone" performance here refers to the device's inherent physical properties as tested in the bench environment, without human interaction during the test itself (though humans operate the testing equipment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guide wires, along with comparative data from predicate devices. The tests directly measure physical properties against these predefined criteria.
8. The sample size for the training set:
This information is not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set.
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