Search Results

Ask a specific question about this device

IMPRA Carboflo™ ePTFE Vascular Grafts are intended for use as vascular prostheses.

IMPRA Carboflo™ ePTFE Vascular Grafts are made primarily of expanded polytetrafluoroethylene (ePTFE) using the same manufacturing procedures that are used to manufacture IMPRA ePTFE Vascular Grafts, the devices to which substantial equivalence is claimed. The region of the graft wall adjacent to the lumen, approximately 20-25% of the total wall thickness, is uniformly impregnated with Carbon particles along the entire length of the carbon impregnated region is formed integral to the outer region of the wall by mixing the PTFE resin mixed with carbon particles, with the non-carbon containing PTFE resin during a singular extrusion process, which results in a monolithic graft wall. The carbon used in the device is USP grade activated charcoal. All other components of the Carboflo graft, namely PTFE, lubricant used as a manufacturing aid, blue pigment incorporated in the orientation lines, and the external support PTFE beading are the same as those used in the manufacture of the predicate devices. These grafts are supplied in the same product configurations as the predicate device, and are packaged, labeled, and sterilized in the same manner as the predicate devices.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document states that the "acceptance criteria for both the new device and predicate devices are the same." However, it does not explicitly list these criteria in a table. Instead, it details comparative performance with a predicate device. Based on the "Comparison of the Device Characteristics to the Predicate" section, the implicit acceptance criteria are related to:

• Physical Properties: The device should not have its physical properties negatively affected by the addition of carbon particles and should be comparable to the predicate.
• Thrombus Free Surface Area: The device should demonstrate at least equivalent or improved thrombus-free surface area compared to the predicate in short-term studies.
• Platelet Accumulation: The device should show at least equivalent or reduced platelet accumulation compared to the predicate in short-term studies.
• Patency (Primary and Secondary): The device's patency rates should be comparable to or better than the predicate device.
• Adverse Events: The device should not introduce new types of complications and the overall complication profile should be comparable to the predicate.

Given this, the table of acceptance criteria and reported device performance is inferred as follows:

Study Details

The provided text describes both non-clinical (bench and animal) testing and a clinical study.

1. Sample Size and Data Provenance (for the Clinical Study):

• Test Set Sample Size:
  • Carboflo group: 81 patients (received Carboflo grafts)
  • Standard ePTFE group: 79 patients (received Standard ePTFE grafts)
  • Total: 160 patients / 160 grafts
• Data Provenance: Prospective, multi-center clinical trial conducted in France between 1990-1994.

2. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical study's outcomes (patency, adverse events). Clinical data was apparently collected and assessed by physicians involved in the trial, but no specific "expert panel" or "adjudication committee" is mentioned beyond the standard clinical practice implied by a prospective multicenter trial.

3. Adjudication method (for the test set):
The text does not explicitly state an adjudication method (like 2+1, 3+1). It mentions that "Adverse events were recorded and documented on Case Report Forms (CRF)," implying standard clinical trial data collection by investigators at each site, followed by central analysis.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, this was not an MRMC study. It was a comparative clinical trial of two devices in human patients, not a study evaluating human readers' performance with and without AI assistance.

5. Effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this was not an MRMC study involving AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (vascular graft) and the studies describe its physical performance and clinical outcomes, not an algorithm's performance.

7. The type of ground truth used:
For the clinical study, the ground truth was clinical outcomes data, specifically:

• Patency: Defined based on follow-up and interventions.
• Adverse Events: Documented clinical occurrences (e.g., thrombosis, infection, amputation, death).
• Patient demographics and risk factors: Recorded at baseline.

8. The sample size for the training set:
Not applicable. This is a medical device, not an AI model, so there is no "training set" in the context of machine learning. The studies described are for validation of the device's performance.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model. For the development of the graft itself, the "ground truth" would be established through engineering principles, material science testing, and pre-clinical animal models (as mentioned in the non-clinical testing section) to optimize the design before clinical trials.

Ask a specific question about this device

IMPRA Carboflo™ ePTFE Vascular Grafts are intended for use in peripheral vascular applications to replace or bypass diseased or occluded blood vessels.

IMPRA Carboflo™ ePTFE Vascular Grafts are made primarily of expanded polytetrafluoroethylene (ePTFE) using the same manufacturing procedures that are used to manufacture IMPRA ePTFE Vascular Grafts, the devices to which substantial equivalence is claimed, The region of the graft wall adjacent to the lumen, approximately 20-25% of the total wall thickness, is uniformly impregnated with Carbon particles along the entire length of the graft. The carbon impregnated region is formed integral to the outer region of the wall by mixing the PTFE resin mixed with carbon particles, with the non-carbon containing PTFE resin during a singular extrusion process, which results in a monolithic graft wall. The carbon used in the device is USP grade activated charcoal. All other components of the Carboflo graft, namely PTFE, lubricant used as a manufacturing aid, blue pigment incorporated in the orientation lines, and the external support PTFE beading are the same as those used in the manufacture of the predicate devices. These grafts are supplied in the same product configurations as the predicate device, and are packaged, labeled, and sterilized in the same manner as the predicate devices.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria is the demonstration of substantial equivalence to the predicate device, the IMPRA ePTFE Vascular Graft. This is primarily assessed through physical properties and clinical performance (patency rates and adverse events).

Study Details

The provided document describes a clinical study and also refers to non-clinical (animal) studies and bench testing. Here's a breakdown of the relevant information:

1. Sample Size Used for the Test Set and Data Provenance:

• Clinical Test Set:

  • Total Patients: 160
  • Carboflo Group: 81 patients
  • Standard ePTFE Group: 79 patients
  • Data Provenance: Prospective, multi-center, randomized clinical trial conducted in France between 1990-1994.

• Non-Clinical (Animal) Test Set:

  • Short-term pre-clinical studies: Dogs and rabbits (specific numbers not provided).
  • Longer-term pre-clinical studies: Specific animal models not explicitly stated beyond "animal studies" (specific numbers not provided).

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

• This information is not explicitly provided for the clinical trial. Clinical trials usually involve investigators and potentially a Data Monitoring Committee, but their specific roles in establishing "ground truth" for each outcome are not detailed in this summary.
• For the non-clinical studies ("Thrombus Free Surface Area" after 3 months, "reduced platelet accumulation"), the judgment would be made by veterinary pathologists or researchers. Specific numbers and qualifications are not mentioned.

3. Adjudication Method for the Test Set:

• Not explicitly described. Clinical trials typically have methods for adjudication of adverse events and endpoints, but the specific process (e.g., 2+1, 3+1 consensus) is not detailed in this summary. Adverse events were "recorded and documented on Case Report Forms (CRF)".

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, this was not an MRMC study. This was a randomized controlled trial comparing two different medical devices in human patients, not a study evaluating human reader performance with or without AI assistance on various cases.

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

• Not applicable. This device is a vascular graft, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here. The document describes the performance of the physical device itself.

6. The Type of Ground Truth Used:

• Clinical Trial: The ground truth for patency was determined by the progression or failure of the graft over time, assessed through clinical follow-up and interventions. Adverse events were identified and recorded based on direct patient observation and medical documentation.
• Non-Clinical (Animal) Studies:
  • "Thrombus Free Surface Area" (measured after 3 months).
  • "Platelet accumulation" (measured in dogs and rabbits).
• Bench Testing: Physical properties of the grafts.

7. Sample Size for the Training Set:

• Training Set for the Device: Not applicable in the context of an AI device. For a manufactured medical device like a vascular graft, "training set" would refer to manufacturing process development and quality control. The document mentions "Extensive bench testing and microscopic analysis" during manufacturing, but does not provide specific sample sizes that would be analogous to an AI training set.

8. How the Ground Truth for the Training Set was Established:

• Not applicable as this is not an AI device. For device manufacturing, ground truth for quality control and material properties (e.g., tensile strength, porosity) would be established through standardized physical and chemical testing methods, often guided by industry standards (e.g., AAMI Vascular Graft Standard).

Ask a specific question about this device