(21 days)
Dynaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.
The Dynaflo bypass graft has a pre-formed cuff at the distal end to promote good hemodynamic performance at the distal anastomosis. Dynaflo grafts are available in various lengths and diameters, with and without external support.
The provided text describes a 510(k) premarket notification for the Dynaflo Bypass Graft. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device meets those criteria in a typical sense for AI/software-as-a-medical-device (SaMD).
Instead, the "acceptance criteria" here are compliance with recognized standards and guidance documents for vascular prostheses, and the "study" is a series of non-clinical performance tests.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Guidance/Standard/Protocol) | Reported Device Performance |
|---|---|
| FDA Guidance Document for Vascular Prosthesis 510(k) Submissions, 11/01/2000 | Conformance was met. |
| ANSI/AAMI VP20-1994, Cardiovascular Implants Vascular Prosthesis | Evaluated based on this standard. |
| ANSI/AAMI/ISO 7198: 1998/2001, Cardiovascular implants - Tubular vascular implants | Evaluated based on this standard. |
| AAMI/ANSI/ISO 10993-1: 1997, Biological evaluation of medical devices -- Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile | Evaluated based on this standard. |
| AAMI/ANSI/ISO 10993-7: 1995, Biological evaluation of medical devices -- Part 1: Ethylene Oxide Sterilization Residuals | Evaluated based on this standard. |
| AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization | Evaluated based on this standard. |
| Predetermined performance criteria of design verification (as specified by applicable standards, guidance's, test protocols, and/or customer inputs) | "All test results confirm the modified device to be substantially equivalent to the predicate device." |
| "Dynaflo Bypass Grafts met all the predetermined performance criteria of design verification." |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of data for an AI/SaMD. The evaluation for the Dynaflo Bypass Graft was based on non-clinical performance data (e.g., mechanical tests, biocompatibility tests), not a data set of patient images or outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a physical medical device (vascular graft), not an AI/SaMD that requires expert ground truth labeling of data.
4. Adjudication Method for the Test Set
Not applicable.
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 physical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device's performance would be derived from:
- Compliance with established engineering and biocompatibility standards: This includes physical and mechanical properties, material safety, and sterilization effectiveness.
- Comparison to the predicate device: The fundamental "ground truth" for a 510(k) is that the new device performs as safely and effectively as a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical device undergoing a 510(k) submission, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.”