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Ask a specific question about this device

The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.

The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment. The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.

The provided text describes a 510(k) premarket notification for a medical device called the "Bi-Directional Tunneler." This clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to establish acceptance criteria and performance. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, and specific study types is not available in the provided document.

Here's why and what can be extracted:

• 510(k) Premarket Notification: This regulatory pathway primarily relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. It generally does not require extensive new clinical trials with clearly defined acceptance criteria in the same way a Premarket Approval (PMA) application might.
• Focus on Substantial Equivalence: The document explicitly states: "The Bi-Directional Tunneler is substantially equivalent in intended use, design, technology/operating principles, materials and performance to the Kelly-Wick Tunneler. Differences between the two devices do not raise any significant issues of safety or effectiveness." This statement is the core of the submission, implying that the safety and effectiveness profile is considered similar to the predicate, which has already met regulatory requirements.

Information that CAN be extracted:

• Device Name: Bi-Directional Tunneler
• Predicate Device: Kelly-Wick Tunneler
• Intended Use: Creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
• Technological Characteristics Summary: Made from stainless steel, supplied non-sterile, equivalent in size and configuration to the predicate. The main difference is the "bi-directional feature," which is stated not to affect safety or effectiveness.
• Regulatory Status: Cleared via 510(k) (K991027), classified as Class II, Product Code 74 DSY.

Regarding your specific points:

1. A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence, meaning its performance is considered equivalent to the predicate, without citing specific performance metrics or acceptance criteria for a new study.
2. Sample sized used for the test set and the data provenance: Not applicable. No new "test set" or clinical data is presented for this substantial equivalence submission.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No new ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable (this is a physical surgical tool, not an algorithm).
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission showing substantial equivalence, not a clinical study outlining specific acceptance criteria or performance metrics derived from new testing.

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The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

The provided text is a 510(k) Premarket Notification for the DISTAFLO™ Bypass Graft. It details the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, it does not contain the specific information required to complete the table and answer all the questions about acceptance criteria and a study proving those criteria.

The document states: "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon." It further mentions the testing was conducted using methods recommended in "ANSVAAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses." It concludes that "The results of all testing indicated that the Distaflo Bypass Graft is suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the Distaflo Bypass Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices."

This is a high-level summary of performance data, but it does not provide specific acceptance criteria values, reported performance metrics, sample sizes, ground truth establishment methods, or details on expert involvement as requested. The document emphasizes substantial equivalence, meaning the device performs similarly to existing, legally marketed devices, rather than meeting specific, novel performance thresholds explicitly stated in this summary.

Therefore, I cannot fill out the table or answer most of the questions with the provided input.

Here's an attempt to answer what can be inferred or directly quoted:

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

2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the device testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing appears to be based on engineering and material performance standards rather than clinical expert consensus for a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

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 is not applicable as the device is a vascular graft, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a vascular graft, not an algorithm. The "standalone" performance here refers to the device's physical and mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device appears to be defined by regulatory standards (ANSVAAMI VP20-1994, 1993 FDA Draft Guidance) and the performance characteristics of its predicate devices, rather than clinical outcomes or expert consensus in the diagnostic sense. The suitability is based on physical and mechanical testing.

8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.

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The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.
Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

Here's a breakdown of the acceptance criteria and study findings for the IMPRA Distaflo™ Bypass Graft, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the testing aimed to demonstrate "substantial equivalence" to predicate devices. The "Performance Data" section indicates:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample size for the "test set" (i.e., the number of Distaflo Bypass Grafts or their components tested). It mentions "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft."
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given the nature of medical device testing for regulatory approval in the US (FDA 510(k)), it is generally assumed that the testing was conducted in a controlled lab environment by the manufacturer.

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

This information is not applicable and not provided in the document. The "ground truth" for this type of device (vascular graft) is established through engineering and biocompatibility testing against predefined standards and performance characteristics, rather than expert consensus on diagnostic images or clinical outcomes in humans at this stage of approval.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation relies on direct physical and mechanical testing against recognized standards and comparison to predicate devices, not on expert adjudication of observations.

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 relevant for diagnostic imaging devices where human readers interpret results, and an AI algorithm might assist them. The Distaflo Bypass Graft is a physical implantable device, and its evaluation does not involve human readers interpreting AI output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is not an algorithm. Its "performance" is inherently standalone, as it's a physical product assessed directly through testing, not an AI model.

7. The Type of Ground Truth Used:

The "ground truth" for the Distaflo Bypass Graft's performance is based on:

• Engineering and Material Standards: Compliance with methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses.
• Predicate Device Performance: Direct comparison of test results to the established performance of legally marketed predicate devices (IMPRA Carboflo Vascular Graft and Venaflo Graft with Carbon).
• Design and Manufacturing Equivalence: Verification that the device uses the same materials, processes, and a design concept (Miller Vein Cuff) found in established devices.

8. The Sample Size for the Training Set:

Not applicable. The Distaflo Bypass Graft is a manufactured medical device, not an AI model requiring a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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IMPRA High Porosity Grafts are indicated for use as vascular prosthesis for bypass or reconstruction of peripheral arterial blood vessels.

The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.

This is a 510(k) premarket notification for a medical device (IMPRA High Porosity Graft), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the new device to predicate devices based on performance data. The "performance data" section (Section G) is the most relevant to your request, but it does not contain the specific information you're asking for in the context of an AI/ML study.

Here's what can be extracted from the provided text about the device's performance and testing, but it fundamentally differs from AI/ML device evaluations:

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

The document states:
"Device testing was performed on the IMPRA High Porosity Graft and compared to the results of testing performed on the IMPRA ePTFE Vascular Graft. The testing was conducted using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance. Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. The results of all testing indicated that the IMPRA High Porosity Graft is suitable for use as vascular prostheses for bypass or reconstruction of arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the IMPRA High Porosity Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices."

Analysis for your table format:

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

• Sample size for test set: Not specified. The document only mentions "device testing was performed."
• Data provenance: Not specified. Standardized test methods (ANSI/AAMI VP20-1994, 1993 FDA Draft Guidance) imply laboratory/bench testing, not patient data in the typical sense of AI/ML studies.

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 is not applicable as it's not an AI/ML device. The "ground truth" for this type of medical device is established by physical and mechanical engineering standards, biocompatibility testing, and functional performance in a laboratory setting, not expert medical opinion on interpretative data.

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

• Not applicable. The "adjudication" in this context refers to compliance with established testing protocols and material science, not a consensus among human reviewers.

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 is not an AI/ML diagnostic or assistive device for human readers.

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

• Not applicable. This device is a physical vascular graft, not an algorithm.

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

• The "ground truth" for this device would be defined by engineering specifications, material science properties (e.g., porosity, tensile strength, burst pressure according to the referenced standards), and successful material performance under simulated physiological conditions as determined by the ANSI/AAMI and FDA guidance documents. It is not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable. This is not an AI/ML device that requires training data or ground truth for algorithmic training.

In summary, the provided document describes a traditional medical device (vascular graft) evaluated for substantial equivalence based on physical and mechanical testing against recognized standards and predicate devices. It does not fit the paradigm of an AI/ML device assessment.

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The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The provided text describes a 510(k) premarket notification for the "VENAFLO™ Vascular Grafts," specifically the "Venaflo Graft with Carbon." This is a regulatory submission for a medical device and not a detailed study report describing acceptance criteria and device performance in the manner of a clinical trial or algorithm validation study.

Therefore, much of the requested information (like specific quantifiable acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, or ground truth establishment details) is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative sense.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo ePTFE Vascular Graft." This implies laboratory or bench testing rather than clinical data.

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

• This is not applicable as the performance assessment appears to be based on physical device testing against recognized standards, not on expert-adjudicated clinical data.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

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 vascular graft, not an AI or imaging diagnostic device.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for this device appears to be defined by established industry standards (ANSI/AAMI VP20-1994) and FDA guidance for vascular prostheses, as well as the performance characteristics of the predicate devices. The document implies that physical/mechanical tests were conducted to demonstrate compliance with these standards and equivalence.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model.

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

• Not applicable. This is a physical medical device, not an AI model.

Summary of Device and Performance Information Provided:

• Device Name: Venaflo™ Vascular Graft (specifically Venaflo Graft with Carbon)
• Intended Use: Subcutaneous arteriovenous conduit for blood access only.
• Predicate Devices: Venaflo Vascular Graft, Venaflo ePTFE Vascular Graft, IMPRA Carboflo® Vascular Graft.
• Performance Basis: Device testing on the cuffed portion, compared to results from the Venaflo ePTFE Vascular Graft.
• Testing Standards: ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance for Vascular Graft Prostheses.
• Conclusion: The testing indicated suitability for intended use and substantial equivalence to predicate devices.

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The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The provided text describes a 510(k) Premarket Notification for the VENAFLO™ Vascular Grafts, specifically the Venaflo Graft with Carbon. This is a medical device submission seeking substantial equivalence to existing predicate devices. Consequently, the document does not contain information typically found in a study demonstrating how a device meets acceptance criteria through performance metrics. Instead, it focuses on demonstrating that the new device has "technological characteristics" and "performance data" that are "substantially equivalent" to predicate devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truthing, and MRMC studies are not present in this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not necessarily to perform a de novo clinical trial with new acceptance criteria.

However, I can extract the information that is available from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that testing was performed to demonstrate substantial equivalence to predicate devices, rather than against specific, quantitative acceptance criteria for superior performance.

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

The document does not specify a "test set" in the context of a clinical study with a specific sample size. The performance data refers to "device testing" performed on the cuffed portion of the Venaflo Graft with Carbon and compared to predicate devices. The nature of this testing (e.g., in vitro, animal, or limited human experience) is not detailed, nor is the number of units tested.

• Sample Size: Not specified.
• Data Provenance: Not specified, but implied to be laboratory/bench testing and potentially pre-clinical (animal) evaluation based on the industry standards cited. There is no mention of human clinical trial data or retrospective/prospective study design in this summary.

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

Not applicable. The document describes laboratory/bench testing against established standards and comparison to predicate devices, not an expert panel adjudicating clinical outcomes or images to establish ground truth for a diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method as would be used in a clinical study involving human assessment.

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 associated with diagnostic imaging devices assessing human reader performance, which is not relevant to a vascular graft.

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

Not applicable. This is a physical medical device (vascular graft), not an algorithm or software requiring performance evaluation in a standalone mode.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established performance characteristics and safety profiles of the predicate devices and compliance with recognized industry standards. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic or therapeutic clinical trial. It's about demonstrating physical and functional equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no "training set" as would be used for machine learning algorithms.

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

Not applicable (see point 8).

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The IMPRA ePTFE Arteriovenous Cuffed Graft is indicated for use as a subcutaneous arteriovenous conduit for blood access.

The IMPRA ePTFE Arteriovenous Cuffed Graft is an expanded polytetrafluoroethylene angioaccess graft [i.e., an IMPRA ePTFE Vascular Graft, the predicate device for this 510(k)] with a modified venous end. The venous end is cuffed, facilitating vessel conformity, a uniform suturing surface, and improved flow through the anastomosis. The IMPRA ePTFE Arteriovenous Cuffed Graft is made from the same materials as the predicate device, i.e., polytetrafluoroethylene (PTFE), lubricant used as a manufacturing aid, a blue pigment used in the orientation lines, and the external support PTFE beading. These grafts are supplied in the same product configurations as the predicate device (straight, stepped, CenterFlex, and stepped CenterFlex), and are packaged, labeled, and sterilized in the same manner as the predicate device.

The provided text outlines the safety and effectiveness of the IMPRA ePTFE Arteriovenous Cuffed Graft, primarily through comparison to a predicate device (IMPRA ePTFE Vascular Graft) and a similar "AVP" device used in a clinical study. However, it does not describe an AI/ML-based device, nor does it present acceptance criteria or a study design in the way an AI/ML product would.

Based on the provided text, I cannot answer questions related to AI/ML device performance, acceptance criteria, test sets, ground truth establishment, or expert involvement as these concepts are not applicable to the medical device described (a vascular graft).

The document focuses on demonstrating substantial equivalence to an existing predicate device, a common pathway for medical device clearance. The "performance" discussed relates to the biological and mechanical performance of the graft itself, not the performance of an AI algorithm.

Therefore, I will extract relevant information about the device's assessment from the provided text, rephrasing the "acceptance criteria" and "study" in the context of a non-AI medical device.

Here's the information parsed from the document, tailored as much as possible to your requested format, but with strong caveats that it's not an AI/ML device:

Device Under Evaluation: IMPRA ePTFE Arteriovenous Cuffed Graft

This document describes a non-AI medical device (a vascular graft). Therefore, many of the requested categories related to AI/ML performance, test sets, ground truth, and expert adjudication are not directly applicable. I will provide information relevant to the device's assessment from the text, interpreting "acceptance criteria" in the context of device performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are primarily based on demonstrating substantial equivalence to a predicate device (IMPRA ePTFE Vascular Graft) and acceptable performance in animal and clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

• Animal Study: The text mentions "eight sheep" were implanted with grafts for the handling assessment. It doesn't specify if the "morphometric analysis" used the same eight or a different number, or how many grafts were implanted per sheep.
• Clinical Study (AVP Graft):
  • Test Set (Cuffed Grafts): 174 AVP grafts (constructed from standard 4mm-7mm Stepped IMPRA ePTFE grafts)
  • Control Set (Conventional Grafts): 50 conventional 4mm-7mm Stepped IMPRA ePTFE grafts
  • Data Provenance: Retrospective for some aspects, but described as patients "entered into this study." All clinical procedures were performed at the Charite Hospital, Berlin, Germany. Between August 1992 to June 1996.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable as this is a physical medical device, not an AI/ML system requiring expert ground truth for classification or detection.

For the clinical study, the "ground truth" was established by direct clinical observation of patient outcomes:

• Surgical procedures, implantation, and immediate postoperative development were observed.
• Follow-up observations were conducted at intervals of six months, up to the second year.
• Outcomes like patency, thrombosis, other complications, and patient deaths were recorded.
• The study was designed and conducted by Dr. Hans Scholz, Chief of Vascular Surgery, Queen Elisabeth Hospital, Berlin, who was also the inventor of the AVP device. His qualifications (Chief of Vascular Surgery) imply expert medical assessment.

4. Adjudication Method for the Test Set

This question is not applicable. Clinical outcomes were directly observed and recorded by the medical team involved in the study under the direction of Dr. Scholz. There's no mention of an "adjudication method" in the sense of resolving disagreements among multiple experts for a test set, as would be relevant for an AI/ML study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specific to evaluating diagnostic devices, often involving multiple human readers assessing cases with and without AI assistance. This document describes a vascular graft.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This concept is not applicable as the device is a physical vascular graft, not an algorithm.

7. The Type of Ground Truth Used

• Animal Study: Histological analysis (to determine thickness of intimal hyperplasia, degree of luminal narrowing, and cellular characterization), photographs of grafts and adjacent vessels at explant, and direct observation of handling characteristics.
• Clinical Study (AVP Graft): Outcomes data from direct patient observation and follow-up, including:
  • Patency rates (cumulative primary patencies)
  • Thrombosis rates
  • Complication rates
  • Mortality rates and causes of death (patient characteristics and comorbidities factored in for death analysis).
  • Flow rates through the shunt (between selected patients).

8. The Sample Size for the Training Set

This question is not applicable. There is no AI/ML "training set" for this physical medical device. The "training" for such devices typically involves extensive engineering design, material science, bench testing, and animal studies to refine the product before human clinical trials.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no AI/ML training set. The "ground truth" for developing this device was established through standard engineering principles, materials science, preclinical (bench and animal) testing, and prior clinical experience with similar devices (the predicate device and the AVP).

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The IMPRA ePTFE Arteriovenous Cuffed Graft is indicated for use as a subcutaneous arteriovenous conduit for blood access.

The IMPRA ePTFE Arteriovenous Cuffed Graft is an expanded polytetrafluoroethylene angioaccess graft [i.e., an IMPRA ePTFE Vascular Graft, the predicate device for this 510(k)] with a modified venous end. The venous end is cuffed, facilitating vessel conformity, a uniform suturing surface, and improved flow through the anastomosis. The IMPRA ePTFE Arteriovenous Cuffed Graft is made from the same materials as the predicate device, i.e., polytetrafluoroethylene (PTFE), lubricant used as a manufacturing aid, a blue pigment used in the orientation lines, and the external support PTFE beading. These grafts are supplied in the same product configurations as the predicate device (straight, stepped, CenterFlex, and stepped CenterFlex), and are packaged, labeled, and sterilized in the same manner as the predicate device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IMPRA ePTFE Arteriovenous Cuffed Graft:

Important Note: The provided document is a 510(k) summary from 1997 for a medical device (vascular graft). It's crucial to understand that the concepts of "acceptance criteria" and "device performance" in the context of this document are primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics in a standalone, prospective clinical trial with pre-defined statistical endpoints like many modern AI/ML device submissions. The "performance" described relates to comparative outcomes between the new device and the predicate or observations from a clinical use of a similar design.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly in terms of safety and efficacy (patency and complication rates). The document doesn't explicitly state quantitative acceptance criteria in the way a modern AI device might. Instead, it compares the new device (or its template) to the predicate device or established clinical outcomes.

2. Sample Sizes Used for the Test Set and Data Provenance

Given this is a physical medical device, not an AI model, the concept of "test set" and "data provenance" (as typically used for AI) requires interpretation:

• Physical Testing: Not explicitly stated as a "sample size" but implies multiple units for various physical tests.
• Preclinical Testing - Animal Study:
  • Sample Size: Numbers of grafts implanted are not explicitly stated, but it involved multiple IMPRA ePTFE Vascular Grafts and IMPRA ePTFE Arteriovenous Cuffed Grafts in an established sheep model. The context suggests a sufficient number for morphometric analysis and statistical comparison.
  • Data Provenance: Prospective animal study (sheep model).
• Clinical Testing:
  • Sample Size:
    • AVP Group (template device for new device): 174 grafts
    • Conventional Group (control): 50 grafts
  • Data Provenance: Prospective clinical study, conducted at Charite Hospital, Berlin, Germany.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Again, for a physical device, "ground truth" is established differently than for AI.

• Physical Testing: The "ground truth" is objective measurement against established standards (ANSVAAMI VP20 - 1994, 1993 FDA Draft Guidance). No individual experts "establish ground truth" in the AI sense here.
• Preclinical Testing - Animal Study:
  • Experts: Not explicitly stated how many pathologists or researchers evaluated the explanted grafts.
  • Qualifications: Implied to be qualified researchers/pathologists capable of morphometric analysis and histological characterization.
• Clinical Testing:
  • Experts: Dr. Hans Scholz, Chief of Vascular Surgery, Queen Elisabeth Hospital, Berlin, designed and conducted the study. He is the inventor of the AVP graft.
  • Qualifications: Chief of Vascular Surgery, inventor of the AVP, conducted procedures at Charite Hospital, Berlin. This implies significant surgical and clinical expertise.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the AI sense of resolving disagreements among multiple human annotators.
  • Physical/Preclinical: Objective measurements and expert interpretation by implied qualified personnel.
  • Clinical: Clinical outcomes were observed and documented by the study investigator. No mention of an independent adjudication committee for clinical events is made, which is common for single-center, investigator-initiated studies from this era.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (especially imaging) where multiple readers interpret cases with and without AI assistance to measure human performance improvement. This device is a vascular graft, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This device is a physical vascular graft, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is assessed through its physical properties and clinical outcomes when implanted.

7. Type of Ground Truth Used

• Physical Testing: Objective measurements against industry standards and guidance documents.
• Preclinical Testing (Animal Study): Histological analysis and morphometric measurements of explanted grafts and vessels.
• Clinical Testing:
  • Outcomes Data: Primary patency, thrombosis rates, complication rates, and survival data from patients receiving the grafts. This is considered robust clinical ground truth.

8. Sample Size for the Training Set

Again, in the context of this physical device, there isn't a "training set" in the machine learning sense. The device's design and manufacturing processes are developed based on engineering principles, material science, and prior experience with predicate devices or templates.

• The AVP graft, which served as a "template," was informed by the inventor's experience and data. The IMPRA ePTFE Arteriovenous Cuffed Graft was developed using the AVP as a template, meaning the knowledge and design of the AVP (including its clinical results) guided the development of the new device. So, the 174 AVP cases could retrospectively be seen as informing the development of the final IMPRA ePTFE Arteriovenous Cuffed Graft.

9. How the Ground Truth for the Training Set Was Established

As there's no "training set" in the AI sense:

• The "ground truth" that informed the design of the IMPRA ePTFE Arteriovenous Cuffed Graft was the experience and data from the AVP graft. This included:
  • Data from the inventor (Dr. Scholz) regarding cuff angle, length, and width.
  • The clinical experience with the AVP graft (174 cases), which demonstrated its safety and efficacy (patency, thrombosis rates). These clinical outcomes were established through direct medical observation, follow-up, and diagnostic procedures for events like thrombosis.

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