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This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.

Here's a breakdown of the acceptance criteria and study information for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, based on the provided text:

Acceptance Criteria and Device Performance (Based on provided text)

The provided text does not contain a detailed table of specific acceptance criteria with numerical targets. Instead, it states a general conclusion about meeting acceptance criteria and performance comparability.

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: The study was "in vitro bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Therefore, there is no information about country of origin or whether it was retrospective or prospective in the clinical sense.

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

   • Not applicable/Not specified. This was an in vitro bench test, not an evaluation relying on expert interpretation of clinical data or images.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a guide wire, not an AI-powered diagnostic or assistive technology. The study was an in vitro bench test.

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

   • Not applicable. This device is a physical medical instrument (guide wire), not an algorithm. The study was an in vitro bench test of its physical properties and functionality.

6. The type of ground truth used:

   • The "ground truth" for this in vitro bench testing would be established engineering specifications, performance standards, and the performance characteristics of the predicate device. The text indicates the device "met the acceptance criteria" and "performed comparable to the predicate device."

7. The sample size for the training set:

   • Not applicable. This was an in vitro bench test of a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, this was not an AI study requiring a training set with established ground truth.

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