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Balloon diameters 1.50 mm - 5.00 mm
The MINI TREKTM OTW and TREKTM OTW Coronary Dilatatoin Catheters are indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
Balloon diameter 1.20 mm
The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery bypass stent graft (≥ 70% stenosis).

The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter are an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

This document describes the acceptance criteria and study proving the device meets the criteria.

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

Explanation: The document states that "These in vitro bench and biocompatibility tests demonstrated that the TREK OTW and MINI TREK OTW Coronary Dilatation Catheters met all acceptance criteria and performed similarly to the predicate devices."

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

The document does not specify the exact sample sizes used for each in vitro bench test or biocompatibility test. It indicates that the tests were conducted "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." This suggests the sample sizes would have been determined by the established guidelines for these types of tests.

The data provenance is in vitro bench tests and biocompatibility tests, not human subject data. Therefore, concepts like "country of origin of the data" and "retrospective or prospective" do not directly apply in the same way they would to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device underwent in vitro bench testing and biocompatibility testing, not studies involving expert evaluation of medical images or patient data to establish ground truth. The "ground truth" for these tests comes from the established physical and chemical standards and guidelines for medical device performance.

4. Adjudication method for the test set

Not applicable. Since the tests were in vitro bench and biocompatibility tests, there was no need for adjudication by experts as would be required in clinical studies involving interpretation of results. The results of these tests are typically objective measurements.

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 document describes the 510(k) submission for a physical medical device (coronary dilatation catheter) and its performance through in vitro and biocompatibility testing. It does not involve AI or human reader interpretation for comparative effectiveness.

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

Not applicable. This device is a physical medical instrument, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The type of ground truth used

The "ground truth" for this study was based on:

• Established industry standards and regulatory guidance: Specifically, "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010."
• Scientific principles and objective measurements: The performance of the catheter was measured against predefined physical and chemical specifications for attributes like tensile strength, fatigue, inflation/deflation characteristics, and biocompatibility.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of medical device.

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