Search Results

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters respectively. The platinum coil wire, 300cm length, is used exclusively for exchange purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.

The provided document describes a submission for substantial equivalence for a medical device, the RADIFOCUS® Glidewire® for coronary use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

However, I can extract information related to the device's performance testing demonstrating substantial equivalence to a predicate device.

Here's a summary of the performance information provided:

Device: RADIFOCUS® Glidewire® for coronary use with platinum (or gold) coil

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" against numerical targets like those for a novel device. Instead, the performance tests demonstrated equivalence to a predicate device (K953533). The document states:

"The Terumo PTCA guide wires (represented in this submission) tested are substantially equivalent to the cleared Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil K953533."

"For all other physical characteristics the Terumo PTCA guide wires represented in this submission were found to be equivalent to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533."

"The Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability." (This is noted as a difference that does not raise new safety/effectiveness concerns).

*Note: Coating Adherence and Coating Flake tests were not performed for this submission as "none of the coating features of the Terumo PTCA guide wires represented in this submission are different from the cleared Terumo PTCA guide wires K953533."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only states "The Terumo PTCA guide wires (represented in this submission) tested...".
• Data Provenance: Not specified. The tests are physical performance tests of the device itself, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical device performance study, not a study requiring expert clinical review or interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication was explicitly mentioned for mechanical device 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 not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the physical tests (Tensile Strength, Torque Transmission, etc.), the "ground truth" is the measured physical properties of the device relative to the predicate device. There is no biological or clinical "ground truth" as described in the prompt.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set mentioned.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set.

Ask a specific question about this device