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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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The Sapphire NC 24 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 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 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 bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. 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 marker 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 Sapphire NC 24 Coronary Dilatation Catheter demonstrated substantial equivalence to its predicate devices through various performance tests. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• 1.5mm to 3.5mm balloons: 24 atmospheres
• 3.75mm to 4.0mm balloons: 22 atmospheres
• 4.5mm to 5.0mm balloons: 20 atmospheres | All acceptance criteria met. |
  | Balloon Fatigue | Not explicitly stated, but implied to withstand repeated inflations/deflations. | All acceptance criteria met. |
  | Balloon Compliance | Not explicitly stated, but implied to maintain precise control of balloon diameter and length under high pressure. | All acceptance criteria met. |
  | Balloon Inflation and Deflation Time | Not explicitly stated, but implied to be within acceptable clinical limits. | All acceptance criteria met. |
  | Catheter Bond Strength | Not explicitly stated, but implied to ensure structural integrity. | All acceptance criteria met. |
  | Tip Pull Strength | Not explicitly stated, but implied to ensure secure attachment of the tip. | All acceptance criteria met. |
  | Flexibility and Kink | Not explicitly stated, but implied to allow for smooth navigation through coronary arteries without kinking. | All acceptance criteria met. |
  | Torque Strength | Not explicitly stated, but implied to allow for effective manipulation by the user. | All acceptance criteria met. |
  | Marker Band Radiopacity | Not explicitly stated, but implied to allow for clear visualization under fluoroscopy. | All acceptance criteria met. |
  | Coating Integrity | Not explicitly stated, but implied to ensure smooth passage and minimize friction. | All acceptance criteria met. |
  | Particulate Evaluation | Not explicitly stated, but implied to be below harmful levels. | All acceptance criteria met. |
  | Balloon Rated Burst Pressure (in-stent) | Not explicitly stated, but implied to perform as expected within a stent. | All acceptance criteria met. |
  | Balloon Fatigue (in-stent) | Not explicitly stated, but implied to maintain integrity within a stent. | All acceptance criteria met. |
  | Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity) | Per ISO 10993-1 standards for biological evaluation of medical devices. | All acceptance criteria met. |
  | Packaging and Sterilization Validation | Not explicitly stated, but implied to maintain sterility and device integrity throughout shelf life. | All acceptance criteria met. |
  | Shelf Life | Not explicitly stated, but implied to maintain device performance over a specified period. | All acceptance criteria met. |

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

The document does not explicitly state the specific sample sizes used for each individual performance test. The tests were conducted on the "subject device," implying representative samples of the Sapphire NC 24 Coronary Dilatation Catheter.

The data provenance is not specified, but given that OrbusNeich Medical (Shenzhen) Co., Ltd is located in China, it is highly probable that the testing was conducted in laboratories within China. The study appears to be retrospective in the sense that these tests were performed on finished devices to demonstrate their compliance with pre-defined standards.

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

This information is not applicable to this type of device and study. The testing described is primarily physical, chemical, and biological performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria for these tests are typically based on engineering standards, regulatory guidelines (like FDA guidance and ISO standards), and internal design specifications, not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective performance testing against predefined criteria, not subjective interpretations requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision support AI), but not for a physical medical device like a coronary dilatation catheter.

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

No, a standalone algorithm performance study was not done. This study is focused on the physical and biological performance of a medical catheter, not an algorithm.

7. The type of Ground Truth Used

The "ground truth" for this study is established through:

• Engineering and Design Specifications: The device is designed to meet specific physical dimensions, pressures, and other performance characteristics.
• Regulatory Guidance: Adherence to FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters") dictates many of the required performance tests and implied acceptance criteria.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) provides the framework and acceptance criteria for biological safety.
• Predicate Device Performance: The subject device's performance is compared against the known performance characteristics of the predicate device (Sapphire NC Plus Coronary Dilatation Catheter) and reference device (Sapphire II Pro Coronary Dilatation Catheter) to establish substantial equivalence.

8. The Sample Size for the Training Set

There is no training set for this study. This is not a machine learning or AI-driven device. The term "training set" is not applicable to the performance testing of a physical medical device.

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

As there is no training set, this question is not applicable.

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The Sapphire® II PRO balloon 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 purposes of improving myocardial perfusion. The Sapphire® II PRO balloon 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® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, 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 (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch 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 guiding sheath or 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 study for the Sapphire II PRO Balloon Dilatation Catheter, focusing on the peripheral use indication:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the device "met all acceptance criteria" and "were similar to the reference devices" for the performed tests.

The performance tests conducted include:

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

The document does not provide specific sample sizes for any of the tests. It refers to testing being "leveraged from the reference device (K173680, K163114)" for many criteria, and "additional testing was performed" for others.

There is no information on the country of origin of the data, and the studies are retrospective in the sense that existing data from previous clearances (K173680, K163114) were used, supplemented by new (implicitly prospective) tests for the peripheral use indication.

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

This document describes a medical device clearance for a balloon catheter, not an AI/software device. Therefore, the concept of "experts" establishing ground truth in the context of clinical imagery or diagnostic data is not applicable here. The ground truth for device performance is established through engineering and performance testing against predetermined specifications.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device performance testing. Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases, often in AI development contexts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI system being evaluated for diagnostic or interpretive tasks by human readers.

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

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established performance standards for balloon dilatation catheters. These standards are likely derived from industry best practices, regulatory guidance, and clinical requirements for the safe and effective operation of such devices. For example, balloon burst pressure needs to meet a certain PSI, and shaft flexibility needs to fall within a defined range.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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