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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 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 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.

Ask a specific question about this device

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.

Ask a specific question about this device

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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