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The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:

· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.

· In-stent restenosis.

· Post-delivery expansion of balloon expandable coronary stents.

The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire NC ULTRA Coronary Dilatation Catheter. It outlines various performance tests conducted to establish substantial equivalence to a predicate device. However, it does not contain the specific level of detail required to fully answer all aspects of your request, particularly regarding clinical study design, expert qualifications, or detailed performance metrics against acceptance criteria.

Here's an attempt to answer your questions based on the available information:

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

The document states: "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use."

While it lists the types of tests performed, it does not provide a table with specific acceptance criteria or quantitative performance results for each test. For example, it lists "Balloon Rated Burst Pressure (in-stent)" as a test, but doesn't state what the accepted pressure was or what the device achieved.

Here's a generalized table based on the types of tests mentioned, but without specific numerical criteria or performance data:

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

The document describes in vitro performance tests and biocompatibility tests. This means the "test set" refers to material samples (e.g., catheter units, material extracts) used for these laboratory tests, not a clinical patient dataset.

• Sample Size: The document does not specify the sample size for the in vitro or biocompatibility tests.
• Data Provenance: Not applicable in the context of in vitro and biocompatibility testing. These are laboratory tests conducted on device components or finished products.

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 question is geared towards clinical studies involving human interpretation or pathology. Since the provided text only details in vitro and biocompatibility testing, there is no information about experts or their qualifications for establishing ground truth as would be required in a clinical setting. These tests typically follow standardized protocols and are evaluated by lab personnel, not medical experts establishing clinical ground truth.

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

Again, this question is relevant for clinical studies with human assessors. For the in vitro and biocompatibility testing described, adjudication methods like N+1 are not applicable. The results are typically quantitative measurements or observations against predefined pass/fail criteria according to established standards (e.g., ISO, FDA guidance).

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an angioplasty catheter, not an AI software or a device that assists human readers in interpreting images. Therefore, this question is not applicable to the information provided.

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

This question is also not applicable. The Sapphire NC ULTRA Coronary Dilatation Catheter is a physical medical device, not an algorithm or software requiring standalone performance testing in that context.

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

For the in vitro performance tests, the "ground truth" is established by adherence to predefined engineering specifications, material properties, and performance benchmarks derived from industry standards (e.g., those in the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").

For biocompatibility testing, the "ground truth" is established by compliance with international standards like ISO 10993-1, which define acceptable biological responses and safety profiles for medical device materials.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical medical catheter and the testing described is primarily in vitro and biocompatibility, there is no concept of a "training set" in this context.

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

As there is no training set for a physical medical device, this question is not applicable.

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The Sapphire ULTRA Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion.

The Sapphire ULTRA Coronary Dilatation Catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in . patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

The Sapphire ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.0mm to 4.0mm. The balloon material is made of the semi-compliant material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube and an inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for Ø1.0-1.5mm configurations). The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm length each, located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire ULTRA Coronary Dilatation Catheter. It outlines the device's description, indications for use, technological characteristics, and performance tests conducted to demonstrate substantial equivalence to predicate devices.

However, the provided document DOES NOT contain information regarding:

• Acceptance criteria for an AI/ML device. This document describes a medical device (a catheter), not an AI/ML diagnostic or prognostic tool. Therefore, there are no AI/ML specific acceptance criteria, study designs (like MRMC), or details about ground truth establishment as would be typically required for such devices.
• Study that proves the device meets AI/ML acceptance criteria. The performance tests listed are for the physical properties and biocompatibility of a medical catheter, not for the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and proof of performance. The document focuses on the physical and biological safety and efficacy of a coronary dilatation catheter, which is a hardware medical device.

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