(84 days)
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation.
VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
The provided document is a 510(k) premarket notification for a medical device called VASCU-GUARD Peripheral Vascular Patch. It demonstrates substantial equivalence to a predicate device, rather than providing a study proving acceptance criteria for a new AI/software device. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device is not applicable to this document.
However, I can extract information related to the device's performance evaluation and testing, even if it's not in the context of AI/software acceptance criteria.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a quantitative table with specific target values and reported performance. Instead, it lists the aspects of the device that were evaluated through non-clinical testing. The conclusion states that "Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch," and that the device is "substantially equivalent to the referenced predicate device."
Evaluated Aspects of Device Performance (from "Summary/Comparison of Technological Characteristics"):
| Evaluated Aspect | Reported Performance (Qualitative) |
|---|---|
| Suture retention | Bench testing results support performance requirements. |
| Thickness | Bench testing results support performance requirements. |
| Burst strength | Bench testing results support performance requirements. |
| Tensile strength | Bench testing results support performance requirements. |
| Collagenase digestion | Bench testing results support performance requirements. |
| Chemical residuals | Bench testing results support performance requirements. |
| Pyrogenicity/ LAL | Bench testing results support performance requirements. |
| Sterilization validation | Bench testing results support performance requirements. Packaging and method of sterilization are the subject of this submission. |
| Packaging and shelf-life | Bench testing results support performance requirements. Packaging and method of sterilization are the subject of this submission. |
| Biocompatibility | Performed according to ISO 10993-1:2009. Biocompatibility indicates the device is biocompatible. |
| Animal studies | Various animal studies conducted to support safety and efficacy. Studies indicate the device is safe and efficacious. |
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: The document does not specify exact sample sizes for each bench test or animal study. It mentions "various animal studies" without quantification.
- Data Provenance: Not specified. The studies are non-clinical (bench testing and animal studies), not human data, so "country of origin of the data" or "retrospective/prospective" in the human data sense are not directly applicable. These are likely internal laboratory/pre-clinical study results.
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)
This is not applicable to the non-clinical testing described. This type of information would be relevant for clinical studies involving expert interpretation of medical images or patient outcomes, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies with human assessors to establish a consensus ground truth, which is not what is being described for these non-clinical tests.
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 document pertains to a physical medical device (vascular patch) and its non-clinical performance, not an AI or software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established by the specifications and measurement standards for each test (e.g., specific force required for suture retention, material integrity under enzymatic digestion, absence of pyrogens in LAL test, histological findings from animal studies). These are objective measurements against predefined standards, and the "ground truth" is inherent in the test methodology and expected outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).