(117 days)
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
The provided text is for a medical device called "exGraft and exGraft Carbon ePTFE Vascular Grafts," which is a vascular prosthesis. This type of device is a physical product, not a software or AI-based diagnostic tool. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined by the prompt (which implies performance metrics like sensitivity, specificity, or human reader improvement for AI/software) does not directly apply here.
The "performance data" section in the document refers to engineering and material testing rather than clinical study data involving humans reading images or making diagnoses.
However, I can extract the information provided in the document and present it in a format that aligns with the spirit of the prompt, reinterpreting "acceptance criteria" as the engineering and material performance requirements for this physical device.
Reinterpretation for a Physical Device:
- Acceptance Criteria: These are the established performance specifications for the physical properties of the vascular graft (e.g., kink radius, microscopic porosity, water entry pressure, MRI safety).
- Reported Device Performance: The results of the tests conducted on the exGraft and exGraft Carbon ePTFE Vascular Grafts to demonstrate that they meet these specifications.
- Study Proving Acceptance: The testing performed to support substantial equivalence to the predicate device.
Analysis based on the provided text:
Acceptance Criteria and Device Performance
The document does not provide specific numerical acceptance criteria or the exact numerical reported performance for each criterion. Instead, it states that "the exGraft and exGraft Carbon are substantially equivalent to the predicate device" based on historical data and performance testing. The "performance testing" lists the types of tests conducted.
Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Physical Device):
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Kink Radius | Testing performed; results support substantial equivalence. |
| Microscopic Porosity (Upper Limit) | Testing performed; results support substantial equivalence. |
| Microscopic Porosity (Lower Limit) | Testing performed; results support substantial equivalence. |
| Water Entry Pressure | Testing performed; results support substantial equivalence. |
| MRI Safety Evaluation | Testing performed; results support substantial equivalence. |
Note: The document explicitly states that the technological differences "do not raise different questions of safety and effectiveness" and "can be evaluated with performance testing," and that the device "leverages historical data from the predicate and reference devices." This implies that the 'acceptance criteria' are met if the new device's performance is comparable to or within acceptable limits of the predicate device for these physical characteristics.
Study Details:
Given that this is a physical medical device (vascular graft) and not an AI/software product, many sections of your prompt (e.g., ground truth, experts, MRMC studies, training/test sets) are not applicable in their traditional sense for this type of device. I will address the relevant parts and explicitly state when a section is not applicable (N/A) based on the provided text for this physical device.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated in terms of the number of graft samples tested for each criterion. The document refers to "testing" being performed.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would have been conducted by the manufacturer, PECA Labs, Inc., in the U.S.
- Nature of Data: This refers to physical and material property measurements, not clinical patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: For a physical device like a vascular graft, "ground truth" is established through standardized engineering and material testing protocols, not by expert consensus on clinical images or diagnoses. The "truth" is the measured physical property.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: Not relevant for material property testing of a physical device.
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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:
- N/A: This is a physical device, not an AI or diagnostic imaging tool. No human reader studies (MRMC) would be relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Physical Property Measurements: The "ground truth" for this device is the objective, measurable physical properties (kink radius, porosity, water entry pressure, MRI safety) determined through standardized laboratory testing. It is not based on expert consensus, pathology, or clinical outcomes data described in this document, though clinical performance would be evaluated separately post-market or in later clinical trials if required.
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The sample size for the training set:
- N/A: There is no "training set" in the context of a physical medical device submission like this. The device is not learning from data. It's manufactured to specifications. "Historical data from the predicate and reference devices" are used for comparison, not for "training."
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How the ground truth for the training set was established:
- N/A: See point 7.
§ 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.”