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To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

The Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires are steerable guide wires available in a maximum diameter of 0.0140" and in lengths of 190 cm DOC® extendable length and a 300 cm exchange length. The distal segment of the guide wire is coated with Hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal end of the guide wire is coated with polytetrafluorethylene (PTFE) and Microglide, which reduces friction of the wire within a catheter.

The provided text describes a 510(k) summary for the HI-TORQUE ADVANCE™ and ADVANCE LITE™ Guide Wires. This is a medical device submission, and the information requested about acceptance criteria and studies (especially those relating to AI, human readers, ground truth, and training sets) is typically found in detailed performance study reports, not in a 510(k) summary. A 510(k) summary aims to establish substantial equivalence to a predicate device, often through bench testing.

Based on the provided text, I can extract the following:

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

The document states: "In vitro bench testing performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet the acceptance criteria and performed comparable to the predicate device." However, the specific acceptance criteria (e.g., tensile strength, friction coefficient, tip flexibility thresholds) and the quantitative reported device performance values are not detailed in this 510(k) summary. It only states that the criteria were met and performance was comparable to the predicate device.

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

The document does not specify the sample size used for the in vitro bench testing. It also does not explicitly state the data provenance (e.g., country of origin) because it's in-vitro bench testing, 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

This question is not applicable to the type of data presented. The study described is in-vitro bench testing of a guide wire, which involves engineering and material science evaluations, not expert-based assessment of medical images or patient conditions to establish "ground truth."

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not what was performed for this device's 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

There is no indication of an MRMC study or any involvement of AI in this 510(k) summary. This document pertains to the market clearance of a medical device (guide wire) based on its physical performance, not an AI-powered diagnostic tool.

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

This question is not applicable. No algorithm or AI component is mentioned for this medical device.

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

For in-vitro bench testing, "ground truth" would typically refer to established engineering standards, material specifications, and physical measurements (e.g., force, dimension, friction) using calibrated equipment. The document indicates the device "met the acceptance criteria," implying comparison against such standards, but it doesn't elaborate on the specific nature of these criteria.

8. The sample size for the training set

This question is not applicable as there is no mention of a "training set" for an algorithm. The study is a bench test of a physical medical device.

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

This question is not applicable for the same reasons as point 8.

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