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

The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide 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 190 cm models are tapered to fit into the hypotube portion 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 radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

The provided text describes the HI-TORQUE WHISPER™ LS and MS Guide Wires and asserts their substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study report that would allow for a comprehensive answer to your request.

Medical device summaries often focus on performance data broadly, without detailing the precise acceptance criteria or the specifics of the studies unless they are novel or demonstrate significant changes in performance. This submission is for a device with a "new tungsten material" but asserts it performs equivalently to the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided document.

Here's what can be extracted and inferred based on the available text:

Acceptance Criteria and Device Performance (Not explicitly stated in detail)

Study Information (Inferred/Not Provided)

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. The document generally states "verification testing" was performed but does not detail the sample sizes or the nature (retrospective/prospective) of the data used. Data provenance (country of origin) is also not mentioned.

2. 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/Not provided. For a guide wire, the "ground truth" and expert involvement in establishing it are typically not relevant in the same way they would be for an imaging AI device. Performance is usually assessed through physical and mechanical testing against engineering specifications.

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

   • Not applicable/Not provided. Adjudication methods are typically relevant for clinical studies where subjective interpretation or classification is involved, such as in diagnostic imaging. This is a physical device, and testing would involve objective measurements.

4. 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:

   • No. An MRMC study is not relevant for this type of device. This is a physical guide wire, not a diagnostic AI tool, so there are no "human readers" or "AI assistance" in the context of an MRMC study.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Not explicitly stated in these terms. For a medical device like a guide wire, "ground truth" would likely refer to established engineering and material science standards, industry benchmarks, and performance metrics (e.g., tensile strength, torque transmission, guidewire trackability, tip retention, coating integrity, biocompatibility, force to fracture, etc.) assessed through laboratory testing. The document states "established acceptance criteria," implying these pre-exist.

7. The sample size for the training set:

   • Not applicable. There is no "training set" for a physical device like this. This terminology applies to machine learning algorithms.

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

   • Not applicable. As there is no training set, this question is not relevant.

Summary of Device Performance Claim:

The study referenced in the 510(k) summary asserts that the HI-TORQUE WHISPER™ LS and MS Guide Wires, with their new tungsten material, met "established acceptance criteria" and perform "in a manner equivalent to the predicate device." The conclusion explicitly states "no new safety or effectiveness issues were raised." This suggests the "study" was primarily a set of verification and validation tests demonstrating the new device's conformity to pre-defined physical and functional specifications, ensuring it performs identically or comparably to its previously cleared predicate.

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