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The Sapphire II PRO 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 II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. 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 1.5-4.0mm 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 (there is only one centrally located marker band for the Ø1.5mm configurations). 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 is related to the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter." This document describes the device, its intended use, and indicates that performance tests were conducted. However, it does not contain specific acceptance criteria values or detailed results of a study in the format requested for AI/medical device performance.

The text details the following about the device's testing:

• Performance Data: "Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation, and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire II PRO coronary dilatation catheter."
• Result: "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire II PRO 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)."

Based on the provided text, I cannot complete the table or provide specific answers to most of the numbered questions because the document lacks the detailed information about acceptance criteria values, specific reported device performance values, sample sizes, ground truth establishment, or any mention of AI or MRMC studies.

The questions posed (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance for AI) are typically relevant for AI/Machine Learning-based medical devices, which is not what the "Sapphire II PRO Coronary Dilatation Catheter" is. This is a physical medical device (a balloon catheter). Therefore, the requested information structure does not directly apply to this type of device and the information is not present in the document.

However, I can extract what is explicitly stated:

• Study Type: The studies conducted were in vitro performance tests and biocompatibility tests. These are standard for physical medical devices and not related to AI.
• Acceptance Criteria Mention: The document states that "The test results met all acceptance criteria," but it does not specify what those criteria are in quantitative terms.
• Ground Truth: For a physical device like a catheter, "ground truth" typically refers to established engineering specifications, material properties, and biological safety standards, rather than expert consensus on diagnostic interpretations or pathology as would be the case for AI. The document implies these were based on "the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."

Therefore, many parts of your request are not applicable or cannot be answered from the given text.

Here's a response based on the absence of the requested AI-specific information and what is available:

The provided document describes the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter," a physical medical device, not an AI or software-as-a-medical-device. As such, many of the requested details, particularly those pertaining to AI model evaluation (e.g., test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), are not applicable to this type of submission and are not present in the document.

The document indicates that various in vitro performance and biocompatibility tests were conducted. It states that "The test results met all acceptance criteria," but it does not provide the specific quantitative acceptance criteria or the numerical reported device performance values.

1. Table of Acceptance Criteria and Reported Device Performance:

Specific tests conducted include:

• In vitro performance tests: Dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation.
• Biocompatibility tests: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma).

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests.
• Data Provenance: The tests are described as in vitro (laboratory) and biocompatibility tests. No patient data or clinical study data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical medical device. "Ground truth" for this device type would be engineering specifications and regulatory standards, not expert interpretations of medical images/data.

4. Adjudication method for the test set:

• Not applicable. (No expert review or diagnostic assessment is described for this device's evaluation.)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating diagnostic performance of AI or imaging systems involving human readers. This device is a catheter.

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 device.

7. The type of ground truth used:

• For in vitro and biocompatibility tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO standards, FDA guidance documents like the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)").

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device; therefore, there is no "training set."

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

• Not applicable. (No training set for an AI model.)

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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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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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