(28 days)
CardioCel 3D is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
The CardioCel 3D device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 4 x 6 cm size with a 60° curve.
The provided document is a 510(k) premarket notification for a medical device called CardioCel 3D. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information typically found in studies designed to establish device performance against predefined acceptance criteria for AI algorithms.
Here's an analysis based on the information provided, highlighting why certain questions cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance:
This document does not specify "acceptance criteria" in the sense of performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it describes verification and validation testing performed on the physical device.
| Test Type | Reported Device Performance |
|---|---|
| Dimensional | Met design inputs. (Exact details of acceptance criteria for dimensions are not provided, but the statement indicates successful verification). |
| Crosslink Stability | Met design inputs. (Specific criteria not detailed). |
| Tensile Testing | Met design inputs. (Specific criteria not detailed). |
| Burst Pressure | Met design inputs. (Specific criteria not detailed). |
| Biocompatibility | Evaluated in a risk assessment and met requirements (implying compliance with ISO standards or similar). |
| Sterility | Evaluated in a risk assessment and met requirements. |
| Packaging | Evaluated in a risk assessment and met requirements. |
| Shelf Life | Evaluated in a risk assessment and met requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable and therefore not provided. The document describes laboratory verification and validation testing of the physical properties and characteristics of the CardioCel 3D device. It is not presenting data from a "test set" in the context of an AI study.
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 question is not applicable to this document. "Ground truth" and "experts" in this context typically refer to establishing diagnostic certainty for an AI algorithm's performance, which is not what this document addresses. The "ground truth" for the device's physical properties would be established by validated measurement standards and laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to this document as no expert adjudication of diagnostic outcomes is involved.
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:
This is not applicable to this document. An MRMC study is relevant for evaluating the impact of AI on human interpretation of medical images or data, which is not the purpose of this 510(k) submission for a tissue patch.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this document. There is no algorithm being evaluated in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the physical device would be established through scientific measurement standards and validated laboratory methodologies (e.g., precise calipers for dimensional verification, standardized tensile testing equipment and protocols for tensile strength, calibrated burst pressure testers, etc.). This is implicitly assumed for "verification and validation testing."
8. The sample size for the training set:
This is not applicable to this document as no AI algorithm is being trained or evaluated.
9. How the ground truth for the training set was established:
This is not applicable to this document as no AI algorithm is being trained or evaluated.
Summary of the document's content regarding device performance:
The document indicates that the CardioCel 3D device underwent "Verification and validation testing" which included:
- Dimensional verification
- Crosslink stability
- Tensile testing
- Burst pressure testing
Additionally, a risk assessment evaluated:
- Biocompatibility
- Sterility
- Packaging
- Shelf life
Conclusion: The results of these tests and the risk assessment "demonstrated that the design outputs of the modified device meet the design inputs in conformance with established design controls." This forms the basis for the FDA's determination of substantial equivalence to the predicate device (CardioCel K130872). The key difference from the predicate is that CardioCel 3D holds a curved shape due to a manufacturing change during crosslinking, while maintaining identical intended use, raw materials, tissue processing, sterilization, packaging, and principles of operation.
§ 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).