(259 days)
The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral.
Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.
The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.
The provided text describes a 510(k) premarket notification for a medical device, the Jotec® FlowLine™ Bipore ePTFE Vascular Graft. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from studies directly comparing the device against acceptance criteria in the way a diagnostic AI device would.
Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Strength | Demonstrated substantial equivalence through mechanical testing and material analysis |
| Chemical Identification of Materials | Demonstrated substantial equivalence through chemical testing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This was not a study involving human subjects or a "test set" in the context of device performance in patients. Performance was assessed through non-clinical bench testing.
- Provenance: The non-clinical bench testing was "as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions." The location of the testing is not specified, but the submitter is Jotec GmbH, located in Hechingen, Germany.
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)
- Not Applicable: "Ground truth" in the context of expert consensus on diagnostic interpretations is not relevant here. The evaluation involved mechanical and chemical compliance with standards, likely interpreted by engineers and material scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication of interpretations was performed as this was not a diagnostic study. Compliance was evaluated against specified test methods and criteria.
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. An MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is not an algorithm. Its performance is inherent to its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" for this device's substantial equivalence was established by adherence to FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions, which outlines mechanical and chemical test requirements, and comparison to the properties of legally marketed predicate devices (Impra and Gore-Tex® ePTFE vascular grafts).
8. The sample size for the training set
- Not Applicable: There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set.
§ 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.”