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The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for post deployment expansion of balloon expandable stents.

The Euphora™ RX Balloon Dilatation catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place.

The document provided is a 510(k) premarket notification for the Euphora™ Rapid Exchange Balloon Dilatation Catheter. It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Based on the provided text, the device discussed is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is a physical medical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study design referencing AI/ML performance (e.g., sample size for test set, data provenance, ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable.

However, I can extract information related to the performance criteria and the non-clinical studies conducted for this conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the "Design Verification in-vitro testing" and "Biocompatibility testing" in accordance with relevant guidance documents and standards. The reported device performance is that it met all these requirements.

The overall conclusion is that "The Euphora™ RX Balloon Dilatation Catheter met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Euphora™ RX Balloon Dilatation Catheter is substantially equivalent in terms of safety and effectiveness to the predicate device."

Regarding the AI/ML specific questions:

2. Sample size 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 a physical medical device, not an AI/ML system.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (for clinical endpoints, as no clinical study was conducted). For bench testing, the "ground truth" would be the engineering specifications and established standards the device had to meet.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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