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510(k) Data Aggregation
(241 days)
For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.
The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.
The provided text is a 510(k) Premarket Notification for a coronary guidewire, which is a medical device. It does not contain information about an AI/ML device or a study proving its performance against specific acceptance criteria in the context of AI/ML.
Therefore, many of the requested fields cannot be filled.
However, I can extract information related to the device's performance testing in a general sense:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | Demonstrated to be substantially equivalent to the predicate device (Galeo Guidewire) |
| Predetermined Acceptance Criteria | Met all pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness |
| Risk Assessment | Risks associated with use found acceptable when evaluated by FMEA (Failure Mode and Effects Analysis) |
| Bench Testing | Performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance, including assessments of performance data |
| Biocompatibility Testing | Performed on patient-contacting materials in accordance with ISO 10993-1 |
The study that proves the device meets the acceptance criteria:
The study proving the device meets its acceptance criteria is a series of "Performance Testing" and "Biocompatibility Testing" as described in the 510(k) summary. These are bench tests and material compatibility tests, not clinical studies involving human patients or AI/ML evaluation.
Regarding the specific AI/ML related questions, the information is NOT available in the provided text:
- Sample size 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 not an AI/ML device study. The performance testing refers to bench tests and biocompatibility tests.
- 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" in the context of expert consensus is for diagnostic AI/ML devices. This device is a physical guidewire validated through engineering and biocompatibility tests.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance would be the objective measurements from bench testing (e.g., tensile strength, torque transmission, guidewire trackability) and the results of biocompatibility assessments against established standards.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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