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

The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J".

The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

The provided text describes a 510(k) summary for a medical device, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating. This summary outlines the device's characteristics, intended use, and performance data to establish substantial equivalence to predicate devices.

However, the document does not provide the detailed information requested regarding the acceptance criteria for a study proving the device meets those criteria, as typically seen in an AI/Software as a Medical Device (SaMD) context. This is a physical medical device, and the evaluation relies on bench testing and in vivo animal models, rather than a clinical study with human readers and ground truth established by experts.

Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

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

The document states that the device "met the acceptance criteria" and "performed similarly to the predicate devices" for the following functional tests:

Note: The specific quantitative acceptance criteria values (e.g., "tensile strength > X N") are not provided in this summary.

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

• Test Set Sample Size: Not specified for the in vitro tests. For the in vivo animal model, the number of animals tested is not specified, only that "two in vivo animal model" studies were conducted.
• Data Provenance: Not specified, but given it's an in vivo animal model, it would be prospective data from an animal study.

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. This is a physical device evaluation based on engineering tests and animal models, not a clinical study involving human expert ground truth establishment in the context of diagnostic interpretation.

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

• Not Applicable. See point 3.

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

• No. This is not an AI/SaMD product.

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

• Not Applicable. This is a physical device. Performance was assessed through standalone bench tests and in vivo animal performance.

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

• For in vitro tests: Engineering specifications/standards and comparative performance to predicate devices and their established performance characteristics.
• For in vivo animal model: Comparative performance to predicate devices in terms of safety and effectiveness, likely assessed by veterinarians or researchers observing physiological responses and procedural outcomes.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. See point 8.

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