Search Results

The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided text is a 510(k) premarket notification for medical devices (Pantera Pro and Pantera LEO catheters). It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and performance data.

Crucially, this document does not contain information about studies related to Artificial Intelligence (AI) or machine learning (ML) models, nor does it provide details about human reader performance, expert adjudication, or ground truth establishment in the context of diagnostic or prognostic AI applications.

The "Performance Data" section solely mentions:

• Product performance - coating integrity and particulates
• Biocompatibility
• Microbiological - Bioburden
• Shelf-Life - coating integrity and particulates

These are standard performance metrics for physical medical devices like catheters, not for AI/ML software.

Therefore, I cannot provide the requested information for an AI/ML-based device based on this document. The information you're asking for would typically be found in a submission for a software as a medical device (SaMD) or an AI-enabled device, which this document is not.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.

The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.

The Ringer perfusion balloon catheter is indicated for balloon dilatation of coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.

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

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

• Sample Size: 60 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, it refers to the study as "G200321, 'Ringer PTCA Study'," which suggests a dedicated clinical study, typically prospective in nature for device clearance.

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

The document does not provide specific details about the number of experts used or their qualifications for establishing ground truth within the clinical study. Angiographic estimations (e.g., final residual stenosis, TIMI flow grade) are typically performed by interventional cardiologists or trained core lab personnel, but this is not explicitly stated.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). Clinical endpoints for device studies are often determined by the treating physician or a study's Clinical Events Committee (CEC), but this information is not elaborated upon.

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 with AI assistance was not done. This study focuses on the performance of a medical device (a balloon catheter) rather than an AI-powered diagnostic or assistive tool for human readers.

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

No, this is a study evaluating a physical medical device (balloon catheter) in human subjects, not a standalone algorithm.

7. The type of ground truth used

The ground truth for the clinical study was established through a combination of:

• Angiographic evaluation: Visual assessment of TIMI flow grade and residual stenosis.
• Clinical outcomes: Occurrence of clinically relevant events, freedom from MACE (Major Adverse Cardiac Events) at hospital discharge, and tolerance of prolonged inflations.
• Procedural observations: Successful delivery, inflation, deflation, removal, and absence of complications like vessel perforation or dissection.

8. The sample size for the training set

This information is not applicable as this is a clinical study for a physical medical device, not a machine learning model that requires a "training set."

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

This information is not applicable, as there is no "training set" in the context of this device's clinical evaluation.

Ask a specific question about this device

Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for:

Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;

Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange catheter, with a non-compliant balloon near the distal tip. Two radiopaque marker bands are located underneath the balloon and fixed on the inner lumen to position the balloon. The hydrophilic coating is located on the whole distal section to reduce friction and enhance the crossing capability. The effective length of the catheter is 145cm, the inner lumen of catheter permits the use of guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is available with balloon diameters of 2.00-5.50mm and balloon lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 2.00-4.00mm balloon diameter. 6F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 4.50-5.50mm balloon diameter.

The provided document does not describe an AI/ML powered device. It details the 510(k) premarket notification for the "Firefighter™ NC Pro PTCA Balloon Catheter", which is a traditional medical device (a balloon catheter for angioplasty).

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/ML device, as this document is not about such a device. The questions about test sets, data provenance, expert adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for a machine learning model are not applicable to the information contained within these pages.

Ask a specific question about this device

The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are 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 VexPander® Coronary Dilatation Balloon Catheters are 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 Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.

The provided text is a 510(k) Summary for a medical device (Coronary Dilatation Balloon Catheters). It describes the device, its intended use, comparison to predicate devices, and the performance data that supports its substantial equivalence. However, this document does not contain information about an AI-based device or a study that involves human readers, ground truth establishment by experts, or MRMC studies.

The "Performance Data" section (Page 5 and 6) lists various non-clinical engineering tests performed on the balloon catheters (e.g., balloon inflation/deflation time, bond strength, flexibility, etc.) and biocompatibility testing. These are physical tests to ensure the device performs as expected and is safe for use in the human body.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, expert ground truth, MRMC studies, or training/test set details because this document does not pertain to an AI/ML medical device.

Here's why the requested information cannot be extracted from the provided text:

• No AI Device: The device described (Coronary Dilatation Balloon Catheter) is a physical medical instrument, not a software or AI-driven diagnostic/assistive tool.
• No AI-Specific Acceptance Criteria: The acceptance criteria mentioned relate to the physical and functional performance of the catheter (e.g., burst pressure, flexibility), not AI performance metrics like sensitivity, specificity, AUC, or concordance with human readers.
• No Human Readers/Experts: There is no mention of a study involving human readers (e.g., radiologists, cardiologists) or experts establishing ground truth for diagnostic purposes. The "experts" in this context would likely be engineers or quality control personnel evaluating the physical device.
• No MRMC Study: An MRMC (Multi-Reader Multi-Case) study is specific to evaluating the impact of AI on human diagnostic performance. This is not applicable here.
• No Training/Test Sets: The concepts of training sets and test sets are relevant to machine learning model development and evaluation, which is not described. The "testing" mentioned is laboratory testing of the physical catheter.
• No Ground Truth for AI: The "ground truth" for a physical device is its engineered specifications and performance under defined conditions, not "expert consensus" or "pathology" in the context of an AI-driven diagnosis.

In summary, the provided document relates to the regulatory clearance of a physical medical device (coronary balloon catheter) through substantial equivalence, based on engineering and biocompatibility testing, not an AI/ML device.

Ask a specific question about this device

The POT PTCA balloon dilatation catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only)

Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.

Based on the provided text, the document is a 510(k) summary for the "POT PTCA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with specific acceptance criteria, sample sizes, and expert adjudication for a novel AI/software device. As such, most of the requested information regarding an AI/ML device's acceptance criteria and study proving its performance is not present in this document.

However, I can extract the information related to performance testing for this physical medical device (a balloon catheter) and note the absence of data pertinent to AI/ML device evaluations.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (for the physical device, not AI/ML):

The document mentions that bench testing was performed and met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only states that the tests demonstrated the device performed as intended and did not impact functionality.

Information NOT available in the document, as it pertains to AI/ML device studies, not physical medical devices like this one:

1. Sample sizes used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here refers to physical bench tests, not a dataset for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and standardized testing, not expert consensus as in image interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its physical properties and mechanical performance, established by engineering standards and measurements.
7. The sample size for the training set: Not applicable (no AI/ML training involved).
8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document (for a physical medical device):

• Device Name: POT PTCA Balloon Dilatation Catheter
• Purpose: To demonstrate substantial equivalence to a predicate device (Apollo Balloon Dilatation Catheter K133852 & K153742). This is a 510(k) submission for a physical medical device, not an AI/ML software.
• Study Type: Bench testing (in vitro) to assess physical characteristics and performance.
• Tests Performed:
  • Dimensional verification
  • Simulated Use
  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Balloon Inflation and Deflation Time
  • Balloon Burst (in stent)
  • Balloon Fatigue (in stent)
• Result of Tests: "In vitro bench testing met all acceptance criteria and demonstrated that the subject device performed as intended and did not impact the functionality of the device."
• Ground Truth (for this device): The ground truth for performance of this physical device is based on engineering specifications, recognized standards, and comparison to the predicate device's established performance.

Ask a specific question about this device

The SC HONK YTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single luer hub for balloon inflation /deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip aids advancement to and through the stenosis. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.

This document is a 510(k) Premarket Notification for the SC HONKYTONK™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, the Emerge™ Monorail PTCA Dilatation Catheter (K163174), through non-clinical testing. This type of submission generally relies on bench testing and does not typically involve clinical studies with human participants or AI performance evaluations as described in your prompt.

Therefore, many of the requested categories are not applicable to this type of regulatory submission and the provided document.

Here's an breakdown based on the information provided and standard 510(k) practices for this type of device:

Acceptance Criteria and Device Performance for SC HONKYTONK™ PTCA Dilatation Catheter

This submission relies on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and meeting of specifications for each test. The "reported device performance" refers to the outcomes of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "patients" or "images" since this is a non-clinical bench study. The "sample size" refers to the number of devices or components tested for each specific bench test (e.g., a certain number of balloons for burst pressure, a certain number of catheters for simulated use). These numbers are not detailed in the summary document but would be part of the full testing report submitted to the FDA.
• Data Provenance: Non-clinical (bench) laboratory testing performed by the manufacturer, Sino Medical Sciences Technology Inc. The data is generated in a controlled laboratory environment, not from human subjects.

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

• Not Applicable (N/A). This is a non-clinical bench study for a PTCA catheter. "Ground truth" in the clinical sense (e.g., expert diagnosis of an image) is not established. The "truth" is based on engineering specifications and validated test methods.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple readers (typically human experts reviewing images/data). This submission is based on automated or semi-automated bench test results against predefined criteria.

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. This is a non-clinical 510(k) submission for a medical device (catheter), not an AI/CADe/CADx device that would involve human reader performance.

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

• No. This is a non-clinical 510(k) submission for a medical device (catheter) with no AI component.

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

• Engineering Specifications and Industry Standards: The "ground truth" for non-clinical testing is based on the device's design specifications, relevant ISO/ASTM standards (e.g., for material properties, biocompatibility), and comparison to the predicate device's established performance parameters. For example, a balloon's rated burst pressure is a design specification, and the test verifies it meets that "ground truth."

8. The sample size for the training set

• Not Applicable (N/A). There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, and specific units are selected for verification and validation (V&V) testing.

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

• Not Applicable (N/A). As there is no training set.

Ask a specific question about this device

The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a low compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) guidewire to facilitate catheter advancement to and through the stenosis or stent that is to be dilated. The proximal portion of the catheter is a sinqle-lumen, stainless steel hypotube that includes a sinqle luer hub for balloon inflation/deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip is aids advancement to and through the stenosis or stent. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aids for the placement of the catheter's balloon. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just proximal of the balloon.

The provided document is a 510(k) summary for a medical device (NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter), which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about studies involving human subjects, AI assistance, or expert readers, which are typically found in submissions for diagnostic or AI-driven devices.

Therefore, many of the requested details regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment are not applicable or derivable from this document. The document primarily describes bench and biocompatibility testing.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance

The document states: "The in vitro bench tests demonstrated that the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device." However, the exact quantitative acceptance criteria for each test (e.g., specific limits for balloon inflation/deflation time, flexibility, or burst pressure) are not explicitly listed in a table within the provided text. The performance data is summarized qualitatively as "met all acceptance criteria" and "performed similarly to the predicate device."

Since the document does not provide a quantitative table of acceptance criteria and reported device performance values, I cannot generate the requested table.

Study Details

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

   • Not provided in the document. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate device" for various non-clinical tests, but the specific numerical acceptance criteria and the quantitative performance results are not detailed.

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

   • Sample Size: Not specified for each non-clinical test.
   • Data Provenance: The tests are described as "Non-clinical laboratory testing" and "in vitro bench tests." The location (e.g., country of origin) of these labs is not specified. They are inherently retrospective in nature, as they evaluate the manufactured device's characteristics against predefined specifications.

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

   • Not applicable. This document describes non-clinical engineering and biocompatibility testing, not studies involving human image interpretation or AI. Therefore, there are no "experts" in the sense of radiologists or other clinicians establishing ground truth for a test set. The "ground truth" for these tests would be objective measurements and predefined engineering specifications.

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

   • Not applicable. See point 3.

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. This was not an MRMC study and does not involve AI assistance or human readers.

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

   • No. This document describes a medical device (balloon catheter), not an algorithm or AI system.

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

   • For the non-clinical tests, the "ground truth" is based on objective engineering measurements (e.g., dimensions, pressure resistance, flexibility) and standardized laboratory testing protocols for biocompatibility as per ISO standards (though specific standards aren't cited for each test, the list of biocompatibility tests performed is standard). There is no "expert consensus" in the clinical sense, pathology, or outcomes data mentioned.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable. There is no "training set" as this is not an AI/ML device.

Ask a specific question about this device

The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.

This document concerns the 510(k) premarket notification for the NC TREK NEO™ Coronary Dilatation Catheter (K220634). The information provided does not contain details about acceptance criteria, device performance, and study design typically found in reports for AI/ML-driven medical devices. Instead, it describes a conventional medical device (a PTCA catheter) and establishes substantial equivalence to a predicate device through a comparison of design, materials, manufacturing, sterilization, and non-clinical performance data.

Therefore, many of the requested fields cannot be filled as they are explicitly related to studies and acceptance criteria for AI/ML devices, which are not applicable here.

Here's a breakdown of the available information and what cannot be provided:

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

The document lists various performance tests conducted on the device. However, it does not provide a table with specific quantitative acceptance criteria or the reported device performance values for these tests. It only states that the tests supported a determination of substantial equivalence and raised no new safety or performance issues.

Performance Tests Completed (no specific acceptance criteria or reported values provided in this document):

• Tip dimensions
• Crossing Profile
• Guidewire Lumen
• Shaft Dimensions
• Proximal Shaft Marker Location
• Catheter Length
• Catheter Preparation
• Balloon Inflation/Deflation Time
• Balloon Rated Burst Pressure (RBP)
• Maximum Compliance Label
• Balloon Compliance
• Balloon RBP (In-Stent)
• Proximal Seal Tensile Strength
• Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile Strength)
• Proximal Adaption Tensile Strength
• Catheter Tip Tensile Strength
• Inner Member Lumen Collapse
• Balloon Fatigue Resistance
• Balloon Fatigue Resistance (In-Stent)
• Hydrophilic Coating- Dry Adhesion of Coating
• Hydrophilic Coating- Coefficient of Friction
• Kink/Flex
• Torque
• Particulates
• Finished Good Sheath Removal
• Balloon Preparation, Deployment and Retraction

Biocompatibility and Chemical Characterization Tests Completed:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic & Pyrogenicity
• Hemocompatibility

2. Sample size used for the test set and the data provenance:
Not applicable. This is a conventional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices manufactured for bench and biocompatibility testing. The exact number of devices or components used for each test is not specified in this summary, nor is data provenance in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert consensus are concepts for AI/ML device validation, which is not relevant for this conventional catheter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and study.

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:
Not applicable. This device is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "truth" for this device's performance is determined by established engineering standards, material properties, and biological compatibility testing, not by expert consensus on clinical data or pathology in the context of an AI/ML algorithm.

8. The sample size for the training set:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

Ask a specific question about this device