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Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lession, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to crossing de novo chronic total coronary occlusions (CTO).

The HI-TORQUE (HT) InfilTrac Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.

The HT InfilTrac Guide Wire Family will be available with the features as listed below:

• 2 tip loads: 11g and 14g
• . 1 coating length: Uncoated Tip
• 1 tip shape: Pre-shaped, micro-J
• 2 lengths: 190 cm, 300cm

The HT InfilTrac Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT InfilTrac Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

The provided text describes a medical device submission (K193126) for the "HI-TORQUE InfilTrac Guide Wire Family." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study to prove the device meets acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested items related to AI/ML studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as related to the bench and simulated use testing mentioned.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance
   The document states: "Results of these tests demonstrated that the HT InfilTrac Guide Wire Family met the functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents. All the outputs tested for HT InfilTrac Guide Wire Family met specification or requirements."

   This is a general statement. Specific acceptance criteria and quantitative performance results are not detailed in this publicly available 510(k) summary. The summary confirms that the device met all unspecified acceptance criteria.

   Acceptance Criteria Type	Reported Device Performance
   Functional requirements	Met specifications
   Dimensional requirements	Met specifications
   Simulated use testing	Met specifications

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not applicable, as this is for a guide wire and involves in-vitro bench and simulated use testing, not clinical data sets for AI/ML.

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 (no AI/ML study).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable (no AI/ML study).

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 (no AI/ML study).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   Not applicable (no AI/ML study).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   For the physical device testing, the "ground truth" or "specifications" were established by the "product specification and external guidance documents." These would likely include engineering design specifications and relevant international standards for medical devices.

8. The sample size for the training set
   Not applicable (no AI/ML study).

9. How the ground truth for the training set was established
   Not applicable (no AI/ML study).

In summary: The provided document is a 510(k) submission for a physical medical device (guide wire). It states that the device successfully met "functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents." However, it does not provide the detailed acceptance criteria or the specific performance results, nor does it involve the type of AI/ML studies typically associated with the other questions.

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