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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic The II - Ore Quide wires with a 0.014" diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and extendable lengths and a 500 em enemange compression of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides tapes in diamover to the up. Thathew re- wire is jacketed with a polyurethane coating that is coated with a hyrophilic coating. The proximal section of the wire is coated with 13 couted with a hyropinias countal tips of the guide wires are available either as a straight tip that is shapeable, or as a pre-shaped "J".

This submission (K013092) is for a guide wire, and the performance data provided focuses on in-vitro bench testing. Therefore, many of the requested criteria related to human studies (e.g., sample size for test set, expert qualifications, MRMC study, human-in-the-loop performance) are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Details of the Study

1. A table of acceptance criteria and the reported device performance:
   (See table above)

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

   • Sample Size: Not specified in the provided text. The text only mentions "in vitro bench testing."
   • Data Provenance: The study was "in vitro bench testing," meaning laboratory testing, not human or animal studies. No country of origin is specified for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as this was in vitro bench testing, not a study requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set:
   Not applicable, as this was in vitro 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:
   Not applicable. This device is a guide wire, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a physical medical instrument, not an algorithm. The "performance" here refers to the physical properties and functionality of the guide wire itself during bench testing.

7. The type of ground truth used:
   The ground truth would be established through engineering specifications and predefined pass/fail criteria for the various bench tests performed on the guide wires (e.g., tensile strength, lubricity, torqueability, tip flexibility, etc.). This information is not detailed in the summary but is implied by "met the acceptance criteria."

8. The sample size for the training set:
   Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable. This is not a machine learning device.

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