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The Sapphire NC Plus 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 Plus 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- 5.0mm 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 (6F for Ø4.5-5.0mm) 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. This Special 510(k) describes the addition of the Ø4.5- 5.0mm balloon configurations to the Sapphire NC Plus PTCA catheter family.

The provided text is a 510(k) Summary for a medical device, the "Sapphire NC Plus Coronary Dilatation Catheter." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device for regulatory clearance. It does not describe an AI/ML-based medical device.

Therefore, the information requested in the prompt, which pertains to AI/ML device validation (e.g., acceptance criteria for diagnostic accuracy, sample sizes for AI model training/testing, expert adjudication, MRMC studies, ground truth establishment methods), is not present in the provided text.

The document discusses performance data related to the physical properties and functionality of the balloon catheter, such as:

• Shelf-Life Performance Testing
• Visual Inspection
• Dimension Inspection
• Balloon Preparation, Deployment, and Retraction
• Balloon Rated Burst Pressure
• Balloon Fatigue
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Tip Pull Strength
• Particulate Evaluation
• Balloon Rated Burst Pressure (within stent)
• Balloon Fatigue (within stent)

The "Performance Data" section states, "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a table of these acceptance criteria or the specific numerical results. It only generically states that testing was performed and met criteria.

To answer your request, here's what can be extracted based on the provided text, and what cannot:

What Can Be Inferred/Stated from the Text (within the context of a physical medical device, not AI):

• Acceptance Criteria and Reported Device Performance: The document states that "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a specific table of these criteria or the numerical performance results of the catheter (e.g., specific burst pressure values, inflation times, etc.). These would typically be detailed in a separate test report referenced by the 510(k) but not included in this summary.
• Sample sizes used for the test set and the data provenance: Not explicitly stated. The tests are for the physical device properties and would involve a sample of manufactured catheters. The provenance would be the manufacturing site.
• Training/Test Set Information (for AI): Not applicable, as this is a physical medical device, not an AI/ML diagnostic.
• Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a physical device is established through engineering and scientific testing standards.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: The performance data listed (e.g., burst pressure, fatigue) represent the standalone performance of the device itself. No human interaction for "reading" or "interpreting" is involved in these specific tests.
• Type of ground truth used: Engineering specifications, material properties, and established test standards for medical devices (e.g., ISO standards, ASTM standards).
• Sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (coronary dilatation catheter) and does not contain the information requested about AI/ML device acceptance criteria or validation studies.

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The Sapphire NC Plus 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) All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

The Sapphire NC Plus 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. This Special 510(k) describes the modification to the Sapphire NC PTCA catheters including a change to the hydrophilic coating and also a change in the brand name to Sapphire NC Plus.

The provided text describes the Sapphire NC Plus Coronary Dilatation Catheter and its submission for 510(k) clearance by OrbusNeich Medical, Inc. It details the device's indications for use, description, and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "The test results met all acceptance criteria, were similar to the predicate device, and ensure that the Sapphire NC Plus coronary dilatation catheter design and construction are suitable for its intended use." However, it does not provide a specific table or quantified acceptance criteria values for each test. Instead, it lists the types of tests performed.

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

The document does not specify the sample size used for any of the performance tests.
The data provenance is for a medical device (catheter) and the tests conducted are in vitro (bench testing) and biocompatibility (laboratory testing) rather than clinical studies with patient data. Therefore, concepts like country of origin for patient data and retrospective/prospective don't directly apply in the usual clinical study sense. The data originates from the manufacturer's testing to support the 510(k) submission.

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

This information is not applicable in the context of this device submission. The "ground truth" for a medical device's engineering and biocompatibility performance is established by standardized testing methods and regulatory guidelines, not by expert consensus on individual cases or images.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involves objective measurements against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical data. This submission is for a medical catheter, where performance is evaluated through bench testing and biocompatibility.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective measurements and laboratory analyses against predefined engineering specifications and international standards for medical devices and biocompatibility. This is distinct from pathology, expert consensus, or outcomes data typically associated with diagnostic or prognostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not described here.

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

Not applicable. No training set is mentioned or implied for this device.

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