Search Results

Ask a specific question about this device

Ask a specific question about this device

The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

Not Found

I am sorry, but the provided text from the FDA 510(k) notification for the Atrium Advanta™ Graft does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria.

This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It defines the "Indications for Use" for the device, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details.

The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study report.

Ask a specific question about this device

The ePTFE Ringed GORE-TEX® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The ePTFE Ringed GPRE-TEX® Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft base tube with ePTFE reinforcing film and optional manufacturing modifications. The proposed modifications consist of replacing external, semi-rigid reinforcing rings of fluorinated ethylene propylene (FEP) with rings created within the graft wall of the ePTFE. These ring structures alternate with a typical graft structure the entire length of the graft. Additionally, small gold dots may be placed at intervals anywhere along the graft, in conjunction with, or as an alternative to the blue orientation markers. The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts.

The provided text describes a medical device, the ePTFE Ringed GORE-TEX® Vascular Graft, and its clearance through the 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.

Here's an analysis based on the available information:

Device: ePTFE Ringed GORE-TEX® Vascular Graft

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The provided document is a 510(k) clearance letter, which does not typically include a table of acceptance criteria and reported performance in the way a clinical study report would. The clearance is based on demonstrating "substantial equivalence" to predicate devices, not on meeting predefined performance metrics through a new clinical trial.

The document states:

• "Mechanical testing data demonstrate the applicant device has mechanical characteristics substantially equivalent to the predicate devices."
• "In vivo testing demonstrates that applicant device performance is substantially equivalent to the predicate devices."

However, the specific acceptance criteria for these "mechanical" and "in vivo" tests, and the exact reported performance values, are not detailed in this summary.

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

Not available. The document mentions "mechanical testing data" and "in vivo testing" but does not specify the sample sizes (number of devices or animals/patients) used for these tests. The provenance of the data (country of origin, retrospective/prospective) is also not provided.

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

Not applicable/Not available. Since the clearance is based on substantial equivalence to predicate devices and likely pre-clinical testing, the concept of "ground truth" established by experts in a clinical trial context (e.g., radiologists interpreting images) is not relevant or not detailed here.

4. Adjudication Method for the Test Set

Not applicable/Not available. No information is provided regarding an adjudication method. This type of methodology is typically associated with clinical studies involving human interpretation of data, which is not the focus of this 510(k) summary.

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 a vascular graft, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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 explicitly detailed for substantial equivalence. The "ground truth" for demonstrating substantial equivalence for a medical device like a vascular graft typically revolves around established performance characteristics of the predicate devices, pre-clinical testing (e.g., animal studies, mechanical fatigue tests, biocompatibility), and manufacturing quality validations. The document mentions "mechanical testing data" and "in vivo testing" showing substantial equivalence to predicate devices, but the specific "ground truth" methods (e.g., histological analysis in animal models, specific mechanical properties benchmarks) are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable/Not available. The concept of a "training set" is usually associated with machine learning or AI algorithm development, which is not relevant to this device. For a traditional medical device, data would be collected for verification and validation, not model training.

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

Not applicable/Not available. As explained in point 8, a "training set" as commonly understood in AI/ML is not relevant here.

Ask a specific question about this device

The Atrium Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ Graft use in aortocronary bypass applications or for use as a patch.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The provided document is a 510(k) clearance letter from the FDA for the Atrium Advanta™ Graft, indicating that the device is substantially equivalent to a legally marketed predicate device. It specifies general controls, regulatory requirements, and the indications for use of the device. It does not contain any details about clinical trials or performance evaluations with the specific metrics you requested.

Ask a specific question about this device

The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

• Thinwall Perma-Pass Grafts are not indicated for blood access. .
• Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manufacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 5mm, thin wall, and lengths sufficient to satisfy most vascular graft applications. The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.

The provided text describes a 510(k) premarket notification for the Perma-Pass™ Vascular Graft, comparing it to an existing predicate device (IMPRA ePTFE Vascular Graft). The core of the submission is to demonstrate substantial equivalence, rather than to establish new safety and effectiveness criteria through a standalone study with defined acceptance criteria and performance metrics.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly available in this document. This document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device based on material, design, and performance characteristics, rather than proving performance against specific acceptance criteria for a new clinical claim.

However, I can extract the relevant information regarding the comparison and the non-clinical tests that implicitly serve as the "study" for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission seeking equivalence, explicit "acceptance criteria" for clinical performance are not stated in the traditional sense of a clinical trial. Instead, the acceptance is based on demonstrating that the Perma-Pass Graft's physical and functional properties are comparable to and exceed physiological requirements like the predicate device.

Study Proving Device Meets Acceptance Criteria:

The "study" conducted for this 510(k) submission consisted of Non-Clinical Tests. The document states:
"Extensive testing of in vitro, functional, physical, and biocompatibility tests have been performed on the Perma-Pass Graft. These tests have shown that the Graft performs comparably to the predicate device. All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases."

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

• Sample Size: Not specified in the document. The testing involves "extensive testing of in vitro, functional, physical, and biocompatibility tests," implying multiple samples of the Perma-Pass Graft and the predicate device were tested for each characteristic. The exact number of units per test or batch size is not reported.
• Data Provenance: The tests are "in vitro, functional, physical, and biocompatibility tests." This indicates laboratory-based testing, likely conducted by the manufacturer (Possis Medical, Inc.) in the USA. It is prospective testing designed to evaluate the properties of the manufactured devices.

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

• This submission relies on objective physical and functional measurements, following established standards (USP or AAMI guidelines). There are no human "experts" establishing a subjective "ground truth" for the test results described. The "ground truth" is the measured value itself, derived from the test methodology.

4. Adjudication method for the test set:

• Not applicable as the tests are objective measurements, not subjective evaluations requiring adjudication.

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 a medical device (vascular graft), not an AI diagnostic tool. No MRMC studies were conducted as part of this submission.

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 the performance claims in this submission is objective, quantitative measurements of physical properties (e.g., pore volume, water entry pressure, tensile strength) and functional performance, compared against the known properties of a legally marketed predicate device and physiological requirements. This is data derived from laboratory testing, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning model. The device itself is manufactured using established processes.

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

• Not applicable. There is no training set for this type of medical device submission.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

This document is a Premarket Notification (510(k)) for a medical device submitted in 1996. It does not describe a study involving an AI/Machine Learning device or software, nor does it contain acceptance criteria or performance data in the context of such studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device (ePTFE Vascular Graft) to predicate devices already on the market, based on material, manufacturing, and general performance specifications.

Ask a specific question about this device