(50 days)
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using methods recommended in "ANSVAAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses."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
| Acceptance Criteria (Inferred from regulatory guidance) | Reported Device Performance |
|---|---|
| Suitable for bypass or reconstruction of peripheral arterial blood vessels | "suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use" |
| Performs in a manner substantially equivalent to predicate devices (IMPRA Carboflo Vascular Graft and Venaflo Graft with Carbon) | "adequately designed to perform in a manner substantially equivalent to that of the predicate devices." |
| Compliance with ANST/AAMI VP20-1994 Cardiovascular Implants - Vascular Prostheses standards | Testing conducted using methods from this standard. |
| Compliance with 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses | Testing conducted using methods from this guidance. |
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.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”