(108 days)
The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.
The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.
The provided text describes the 510(k) summary for the TORAYGUIDE™ Guidewire and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, detailed performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document makes a general statement: "Applicable testing was conducted on the TORAYGUIDE guidewire in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the TORAYGUIDE Guidewire possesses performance characteristics that make it acceptable for its intended use." This indicates that some testing was done and passed, but the specifics are not provided in the summary.
Therefore, most of the information requested cannot be extracted directly from the given text.
Here is a summary of what can be inferred or directly stated from the provided text, along with what cannot be found:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text. The document generically states "All samples met the acceptance criteria."
- Reported Device Performance: No specific performance metrics or results are reported in this summary. It only states that the guidewire "possesses performance characteristics that make it acceptable for its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "All samples met the acceptance criteria."
- Data Provenance (country of origin, retrospective/prospective): Not specified.
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 as this is a medical device (guidewire) and not an AI/diagnostic software. Ground truth in this context would likely refer to engineering specifications and physical performance tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of medical device's performance 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. This is a physical medical device (guidewire), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" would likely be engineering specifications and physical testing standards for guidewires (e.g., tensile strength, torqueability, flexibility, kink resistance). These specific standards or methods are not detailed in the summary.
8. The sample size for the training set
- Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device, not an AI model.
In summary, the provided 510(k) summary is for a guidewire and primarily focuses on demonstrating substantial equivalence to a predicate device through physical and performance testing that met general FDA guidance. The detailed information typically requested for AI/diagnostic software performance studies (like sample sizes, expert qualifications, ground truth methodology) is not relevant or available in this type of device submission summary.
§ 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.