(70 days)
The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.
- Thinwall Perma-Pass Grafts are not indicated for blood access. .
- Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava
The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manıfacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 6mm, thin and standard wall, and lengths sufficient to satisfy most vascular graft applications.
The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.
The provided text describes the "Perma-Pass™ Vascular Graft" and its comparison to a predicate device, focusing on technical characteristics and physical properties. It does not contain information about acceptance criteria and a study proving device performance in the manner typically described for AI/ML devices, as this is a traditional medical device submission (510(k)) from 1999. The submission establishes substantial equivalence on the basis of material, intended use, and comparative physical/functional test results to a legally marketed predicate device, rather than through clinical performance metrics or AI/ML specific acceptance criteria.
Therefore, many of the requested elements for AI/ML device studies (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable or not present in this document.
However, I can extract information related to the device's characteristics and how it was compared to the predicate, which serves as a form of "acceptance criteria" for demonstrating substantial equivalence in this context.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance (Interpreted for a Traditional Device 510(k) Submission)
The "acceptance criteria" here are implicitly defined by demonstrating that the Perma-Pass Graft's materials, intended use, manufacturing process, and key physical properties are comparable or superior to the predicate device, and that all performance results exceed physiological requirements.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a traditional device demonstrating substantial equivalence, the "acceptance criteria" are interpreted as the range or characteristics of the predicate device, and the "reported device performance" is the Perma-Pass Graft's corresponding characteristics. The goal is to show comparable or superior performance.
| Characteristic | Predicate Device (IMPRA Graft) | Perma-Pass Graft (Reported Performance) | Comparison/Acceptance (Interpreted) |
|---|---|---|---|
| Materials | PTFE: No additives | PTFE: No additives | Equivalent |
| Markings | Longitudinal orientation | Longitudinal orientation | Equivalent |
| Clinical application | Vascular access and others | Vascular access and others | Equivalent |
| Fabrication | Paste extrusion, expansion, sintering | Paste extrusion, expansion, sintering | Equivalent |
| Structure/Configuration | Straight, isodiametric | Straight, isodiametric | Equivalent |
| Length (all sizes) | 50cm | 70cm | Different, but acceptable |
| Internal Diameter (6T) | 5.89mm | 6.06mm | Comparable |
| Internal Diameter (6S) | 5.93mm | 6.08mm | Comparable |
| Wall Thickness (6T) | 0.431mm | 0.422mm | Comparable |
| Wall Thickness (6S) | 0.665mm | 0.643mm | Comparable |
| Pore Volume (6T) | 71% | 68% | Comparable |
| Pore Volume (6S) | 72% | 72% | Equivalent |
| Internodal Distance (6T Inner) | 17µm | 18µm | Comparable |
| Internodal Distance (6T Outer) | 20µm | 20µm | Equivalent |
| Internodal Distance (6S Inner) | 25µm | 25µm | Equivalent |
| Internodal Distance (6S Outer) | 22µm | 26µm | Comparable |
| Kink Diameter (6T) | 18mm | 16mm | Comparable (slightly less resistant to kinking) |
| Kink Diameter (6S) | 16mm | 13mm | Comparable (slightly less resistant to kinking) |
| Water Entry Pressure (6T) | 321mmHg | 326mmHg | Comparable (slightly higher) |
| Water Entry Pressure (6S) | 274mmHg | 228mmHg | Comparable |
| Pressurized Burst Strength (6T) | 303kPa | 394kPa | Better (higher) |
| Pressurized Burst Strength (6S) | 405kPa | 486kPa | Better (higher) |
| Pressurized Burst after repeated puncture (6S) | 237kPa | 324kPa | Better (higher) |
| Tensile Strength Longitudinal (6T) | 119N | 135N | Better (higher) |
| Tensile Strength Longitudinal (6S) | 120N | 207N | Better (higher) |
| Tensile Strength Circumferential (6T) | 3.03N/mm | 4.47N/mm | Better (higher) |
| Tensile Strength Circumferential (6S) | 3.73N/mm | 4.42N/mm | Better (higher) |
| Suture Retention Strength Longitudinal (6T) | 282g | 447g | Better (higher) |
| Suture Retention Strength Longitudinal (6S) | 451g | 734g | Better (higher) |
| Suture Retention Strength Oblique (6T) | 260g | 496g | Better (higher) |
| Suture Retention Strength Oblique (6S) | 434g | 498g | Better (higher) |
Note on Acceptance: The document states: "All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases." This implies the predicate's performance was considered sufficient and the Perma-Pass Graft either matched or exceeded it, thus meeting the criteria for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of number of grafts tested for each characteristic. The "test set" refers to samples of the Perma-Pass Graft and the predicate device.
- Data Provenance: The tests were "in vitro, functional, physical, and biocompatibility tests." No clinical data (human or animal studies) with country of origin is mentioned. The tests were likely conducted in a lab setting, presumably at Possis Medical, Inc.'s facilities in Minneapolis, Minnesota, USA, or by contracted labs. This is not a human clinical study, so terms like "retrospective" or "prospective" are not directly applicable.
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. This is a traditional device submission based on physical and functional testing, not expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert adjudication process described, as the evaluation was based on objective physical and functional measurements.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance characteristics would be the measured physical and functional properties of the grafts themselves, quantified through standardized laboratory test methods (e.g., tensile strength, burst strength, pore volume measurements).
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.”