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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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The NC Euphora™ Rapid Exchange 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 is also indicated for post deployment expansion of balloon expandable stents.

The NC 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 NC Euphora device is available in balloon diameters of 2.0mm to 5.0mm and in balloon lengths of 6mm to 27mm. The NC Euphora device has a nominal pressure of 12atm and a rated burst pressure of 20atm.

This document is a 510(k) summary for the Medtronic NC Euphora Rapid Exchange Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. It focuses on non-clinical performance and biocompatibility rather than clinical studies.

Here's an analysis based on your request, structured to address the points directly from the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it states that the device met all specified design and performance requirements.

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

• Sample Size: The document does not specify the sample sizes used for the in-vitro bench tests or biocompatibility tests. It only lists the types of tests performed.
• Data Provenance:
  • Country of Origin: The applicant is Medtronic, Inc., Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. This suggests the testing was either conducted in Ireland or sponsored by the Irish entity.
  • Retrospective or Prospective: The testing described (in-vitro bench tests, biocompatibility tests, pre-clinical in-vivo (non-GLP) studies) are inherently prospective tests performed to qualify the device.

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)

This information is not applicable and not provided in the document. The document describes non-clinical testing (bench, biocompatibility, non-GLP in-vivo for radiopacity) rather than studies that would involve human expert interpretation for ground truth establishment (e.g., image analysis by radiologists).

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

This information is not applicable and not provided in the document. Adjudication methods typically apply to clinical studies where multiple human readers assess a common set of cases, and a process is used to resolve disagreements or establish a consensus ground truth. The presented studies are non-clinical.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device." The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable. The device is a physical medical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm independent of human intervention.

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

Since this submission is for a physical device and relies on non-clinical testing for substantial equivalence, the "ground truth" refers to established engineering specifications, material standards, and biological safety standards.

• For design verification in-vitro testing: Engineering specifications, recognized industry standards, and regulatory guidance documents (e.g., "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010").
• For biocompatibility testing: International standards (e.g., ISO10993-1:2009, USP, ASTM) define the acceptance criteria for biological safety.
• For pre-clinical in-vivo (non-GLP) studies for radiopacity: Visual assessment by trained personnel against a defined standard for visibility.

8. The sample size for the training set

This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and previous device experience.

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

This question is not applicable for the reasons stated above (not an AI/ML device requiring a training set). The "ground truth" for the device's design and manufacturing is established through engineering design specifications, material science, and manufacturing process controls.

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