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The Sapphire NC 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
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

The Sapphire NC coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0-4.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Sapphire NC Coronary Dilatation Catheter (a PTCA Catheter)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes in vitro performance tests and biocompatibility tests. It does not mention a "test set" in the context of patient data or clinical images. The testing was performed on the device itself.

• Sample Size: Not explicitly stated as a number of devices/units, but implied to be sufficient for rigorous testing.
• Data Provenance: The tests are in vitro and biocompatibility, meaning they were conducted in a laboratory setting, not on patient data. Therefore, there is no country of origin or retrospective/prospective designation relevant to the data provenance in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable. The device is a physical medical device (catheter) and the testing described is primarily mechanical/physical performance and biocompatibility. "Ground truth" in the context of expert consensus on diagnostic imaging or clinical outcomes is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes pre-market testing for a medical device (catheter) based on in vitro performance and biocompatibility, not a diagnostic imaging AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by the predefined specifications and acceptance criteria for each in vitro and biocompatibility test. These criteria are likely based on industry standards, regulatory guidance (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters), and performance of predicate devices.

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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The Sapphire 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

The Sapphire coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.5-4.0mm and lengths from 10-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment with the exception of balloon diameters less than 2.0mm which incorporate a centrally positioned single marker band. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes the regulatory submission for the Sapphire Coronary Dilatation Catheter, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific AI algorithm's performance against acceptance criteria. Therefore, much of the requested information regarding AI-specific criteria, studies, and data provenance is not applicable.

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the test results "met all acceptance criteria" and were "similar to predicate devices." However, it does not explicitly list specific numerical acceptance criteria for each performance test. Instead, it refers to general guidelines and the successful fulfillment of these criteria.

The document also states that the tests "ensure that the Sapphire coronary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)." This guidance document would contain the specific acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document describes product performance and biocompatibility tests, which are laboratory or in vitro studies, not typically involving "test sets" in the context of AI algorithms or clinical trials. Therefore:

• Sample size for the test set: Not applicable in the context of clinical or AI performance. The number of physical units or samples tested for each in vitro or biocompatibility assessment is not specified in this summary.
• Data provenance: Not explicitly stated as country of origin, retrospective, or prospective, as these are not clinical studies. These are laboratory-based validation tests performed internally by the manufacturer (OrbusNeich Medical, Inc.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The device is a medical catheter, not an AI diagnostic tool that requires ground truth established by human experts for performance evaluation. The "ground truth" for these tests would be the established scientific and engineering principles for device performance and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable. As these are laboratory tests, an adjudication method for human interpretation of results is not relevant. The results are based on objective measurements against engineering specifications and biocompatibility standards.

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

This information is not applicable. The device is a physical medical catheter, not an AI algorithm intended to assist human readers. Therefore, an MRMC study and effect size of AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance and biocompatibility studies:

• Ground Truth: The "ground truth" for the device's performance is based on established engineering specifications, international standards, and regulatory guidelines (e.g., FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). The tests aim to demonstrate that the device functions according to its design and regulatory requirements.

8. The Sample Size for the Training Set

This information is not applicable. The device is subjected to engineering and biocompatibility testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" or "ground truth" establishment in the context of machine learning for this physical medical device.

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