Search Results

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 purpose of improving myocardial perfusion
The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm 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 now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.

However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.

Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.

Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:

• Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:

  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Catheter Bond Strength
  • Tip Pull Strength
  • Radiopacity
  • Coating Integrity
  • Dimensional Verification
  • Shaft Burst
  • Balloon Inflation and Deflation Time
  • Flexibility and Kinking
  • Torque Strength
  • Particulate Evaluation
  • Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
  • Sterilization
  • Visual Inspection
  • Balloon Preparation, Deployment, and Retraction

• Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.

Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.

Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:

Table of Acceptance Criteria and Reported Device Performance:

(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)

Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):

1. Sample sizes used for the test set and the data provenance:

   • Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
   • Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.

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

   • Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. This refers to adjudication in human reader studies for diagnostic accuracy.

4. 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:

   • N/A. This device is a physical balloon catheter, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.

7. The sample size for the training set:

   • N/A. This device is not an AI model requiring a training set.

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

   • N/A. No training set is used for this type of device.

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

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 Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of instent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

The Scoreflex PTA Scoring Balloon Catheter is designed for easy guidewire exchange and available with balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0mm, balloon lengths of 15, 20 and 40mm and a catheter working length of 40, 90, or 150cm. There are two catheter designs within the Scoreflex family: the no-coil design has a smaller shaft profile than the corresponding coil design catheter of the same balloon configuration which will allow for access to more distal lesions while the coil design minimizes balloon curvature during inflation. The balloon is made of a semi-complaint material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon jacketed stainless steel hypotube and the scoring wire is laser welded to the distal end of the hypotube. The proximal shaft joins with a smooth transition to the distal shaft (composed of an outer nylon tube with the balloon/tip tube and scoring wire welded at the distal tip). The cutting section of the scoring wire is outside of the balloon. Two radiopaque platinum/iridium marker bands are located on the scoring wire and aligned with the balloon shoulders to ensure accurate positioning of the balloon. The tip lumen is compatible with either a standard 0.014 inch (0.36mm) or 0.018 inch (0.46mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. The catheter is lubricated with hydrophilic coating on the tip and the distal outer body surface; the tip lumen and the balloon are lubricated with silicone coating.

The provided text is a 510(k) Summary for a medical device (Scoreflex PTA Scoring Balloon Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific clinical acceptance criteria for an AI/ML product.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance in the context of an AI/ML device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample size details for a test set, data provenance, number of experts, adjudication methods, or ground truth establishment for an AI/ML system's evaluation.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm-only performance.
• Details about training set sample size or how ground truth was established for a training set in an AI/ML context.

The "Performance Data" section lists various engineering and biocompatibility tests performed on the physical catheter device, such as "Balloon Rated Burst Pressure," "Shaft Burst," "Balloon Fatigue," and "Biocompatibility." These tests are typical for physical medical devices to ensure their safety and mechanical integrity, but are not related to the performance evaluation of an AI/ML algorithm.

The conclusion states that "The Scoreflex PTA Scoring Balloon Catheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, these "acceptance criteria" refer to the engineering and biocompatibility specifications for the physical catheter, not the performance metrics of an AI/ML system.

Ask a specific question about this device

The Teleport microcatheters are indicated for:
supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
exchanging guidewires in the coronary and peripheral vasculature.
the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The Teleport family of microcatheters are single lumen catheters, offered in two shaft sizes (2.0F and 2.1F) with working lengths of 135cm or 150cm, designed for use in the coronary, peripheral, and abdominal vasculature. The shaft profiles gradually decrease from 2.6F (0.034") to 2.0F (0.0265") for the 2.0F configuration (Teleport), and 2.7F (0.036") to 2.1F (0.0275") for the 2.1F configuration (Teleport Control) respectively. The catheter consists of four sections: body shaft, proximal tip shaft, distal tip shaft, and a radiopaque tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The provided text describes a 510(k) summary for the Teleport Microcatheter, focusing on its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it lists the types of performance tests conducted and a general statement that "The Teleport microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as these are not present in the provided document.

The document confirms that standalone performance testing was done for the device, as indicated by the list of "Performance Testing" conducted, which did not involve human readers (e.g., flow rate, burst pressure, torque strength).

Ground truth for these engineering and material performance tests would be established through predefined engineering specifications and standards (e.g., a specific flow rate must be achieved, a certain pressure must be withstood before burst).

Ask a specific question about this device

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.

Ask a specific question about this device

The Sapphire II PRO 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 purposes of improving myocardial perfusion.

The Ø1.0-1.25mm 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 1.0-1.25mm and lengths from 5-15mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. One radiopaque platinum marker band is centrally 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.

The information provided is about the Sapphire II PRO Coronary Dilatation Catheter (1.0-1.25mm configurations). This is a medical device, and the document describes a clinical study to assess its safety and effectiveness.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a pass/fail format for each criterion. Instead, it describes a primary endpoint for Device Procedural Success and secondary endpoints for effectiveness and safety, along with their observed results. I will construct a table reflecting these key outcomes.

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

• Sample Size: 61 patients (67 lesions)
• Provenance: Prospective, open-label, multicenter, single-arm, observational study conducted at four (4) US sites.

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

The document mentions "Angiographic Core Lab" and "Clinical Event Committee (CEC) adjudication" for various endpoints.

• Angiographic Core Lab: Responsible for reporting several secondary peri-procedural endpoints (e.g., vessel perforation, dissection, TIMI flow, MLD). The number and qualifications of experts in this core lab are not specified in the provided text.
• Clinical Event Committee (CEC): Responsible for adjudicating in-hospital clinical safety and efficacy endpoints (e.g., MACE, MI, TLR, TLF, ST). The number and qualifications of experts in the CEC are not specified in the provided text.
• Site Reported and Adjudicated: Some endpoints were site-reported and then adjudicated, implying review by professionals at the study sites, but specific numbers and qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document states:

• "Site Reported and Adjudicated" for some peri-procedural endpoints.
• "Core Lab Reported" for other peri-procedural endpoints.
• "Clinical Event Committee (CEC) adjudication" for in-hospital clinical safety and efficacy endpoints.

However, the specific adjudication method (e.g., 2+1, 3+1 consensus) used by the Core Lab or CEC is not detailed in the provided text.

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

There is no mention of an MRMC study or AI assistance in this document. This study is a clinical trial for a coronary dilatation catheter, not an AI-powered diagnostic device.

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

This question is not applicable. The device is a physical medical instrument (a catheter) and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth was established through a combination of:

• Clinical observation and assessment: By the treating physicians at the study sites, reported as "Site Reported."
• Angiographic Core Lab analysis: Objective assessment of angiograms.
• Clinical Event Committee (CEC) adjudication: Expert review and classification of clinical events.
• Outcomes data: Such as the occurrence of MACE, MI, and TLR.

8. The sample size for the training set

This question is not applicable as the study describes a clinical trial for a physical medical device, not a machine learning model. There is no concept of a "training set" for the device itself in this context.

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

This question is not applicable as there is no training set for the device.

Ask a specific question about this device

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15-120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) Summary for the Jade PTA Balloon Dilatation Catheter. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance with human readers. The information provided is for a physical medical device (a balloon catheter), not an AI/ML diagnostic or assistive tool.

Therefore, I cannot fulfill your request as the necessary information regarding AI/ML acceptance criteria, human reader studies, ground truth establishment for AI/ML, sample sizes for training/test sets for AI/ML, or expert qualifications for AI/ML ground truth is not present in the provided document.

The "Performance Data" section in the document refers to in vitro performance tests and biocompatibility tests for the physical catheter, not an AI/ML system.

Ask a specific question about this device