(92 days)
The AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.
Albograft Vascular Prosthesis is a knitted/woven tubular polyester fabric, impregnated with bovine collagen.
The provided text describes a 510(k) summary for the Albograft™ Vascular Prosthesis, but it does not contain acceptance criteria or a study designed to explicitly prove the device meets acceptance criteria in the typical sense of a diagnostic or AI device study.
Instead, this document describes a pre-market notification for a medical device (a vascular prosthesis) seeking substantial equivalence to a predicate device. The "study" mentioned is a retrospective clinical review to demonstrate the device's performance in a real-world setting.
Here's a breakdown of the requested information, addressing what is present and what is absent:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document does not define explicit acceptance criteria in the format of specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that are then directly tested against in a controlled study.
Instead, the "Summary of Retrospective Clinical Review" provides real-world performance data for the Albograft™ Vascular Prosthesis. The implicit "acceptance" for this type of device in a 510(k) process is demonstrating substantial equivalence to a predicate device, which is often supported by showing comparable clinical outcomes. The clinical outcomes presented are intended to support the safety and effectiveness of the device when used for its intended purpose.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance (from Retrospective Clinical Review) |
|---|---|---|
| 30-day Mortality | (Implicit: Low mortality) | 4.5% (n=3) |
| Graft Infection Rate | (Implicit: Low/No infection) | No graft infection recorded during follow-up |
| ABI Improvement | (Implicit: Significant improvement) | Improved significantly from 0.46 to 0.89 |
| Fontaine Stage Improvement | (Implicit: Shift to lower stages) | Majority of patients in Fontaine stage I and IIa at last follow-up visit (Pre-Op: 67.7% IIb, 14.5% III, 17.7% IV; Post-Op: 62.9% I, 17.7% IIa) |
| 12-month Primary Patency Rate | (Implicit: High patency) | 89.4% (SE 4%) |
| 24-month Primary Patency Rate | (Implicit: High patency) | 89.4% (SE 4%) |
| 12-month Secondary Patency Rate | (Implicit: High patency) | 95.1% (SE 2.8%) |
| 24-month Secondary Patency Rate | (Implicit: High patency) | 95.1% (SE 2.8%) |
| 12-month Limb Salvage Rate | (Implicit: High limb salvage) | 98.4% (SE 2.8%) |
| 24-month Limb Salvage Rate | (Implicit: High limb salvage) | 98.4% (SE 2.8%) |
Note: The "Acceptance Criteria" column is filled with "Implicit" as the document does not explicitly define quantitative thresholds that were pre-defined as regulatory "acceptance criteria" for the clinical review. These are observed clinical outcomes. The determination of "substantial equivalence" would involve comparing these outcomes with those expected or reported for the predicate device, or generally accepted clinical outcomes for such procedures.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 66 consecutive patients
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from LeMaitre Vascular, Inc. in Burlington, MA, USA, and the clinical review spans from Jan 1, 2007, to March 31, 2009. The retrospective nature suggests a single clinical site or registry.
- Retrospective or Prospective: Retrospective Clinical Review
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. As this is a retrospective review of patient outcomes related to a surgical implant, the "ground truth" would generally be established by the clinical records, diagnostic tests, and assessments made by the treating physicians and hospital staff. There is no mention of an independent panel of experts establishing ground truth for the purpose of a study evaluating a diagnostic device.
4. Adjudication method for the test set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert readers for diagnostic tasks. This retrospective clinical review focuses on observed patient outcomes, not on interpretation of data by multiple experts needing 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a vascular prosthesis (surgical implant), not an AI-assisted diagnostic device. Therefore, no information on human reader improvement with/without AI assistance is applicable or provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this clinical review appears to be patient outcomes data and clinical diagnostics as recorded in medical charts and follow-up visits. This includes:
- Pre-operative diagnoses (aneurysmal or occlusive disease, Fontaine stages, TASC II classification)
- Ankle Brachial Index (ABI) measurements
- Surgical results and post-operative complications (mortality, infection)
- Follow-up assessments (Fontaine stage, ABI, patency rates determined by various clinical methods, limb salvage rate).
8. The sample size for the training set
Not applicable/Not provided. This is not a study of an AI algorithm requiring a training set. The clinical review describes the performance of a physical medical device in patients.
9. How the ground truth for the training set was established
Not applicable/Not provided. As stated above, this is not an AI study, and therefore, no training set with associated ground truth was established for this submission.
§ 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.”