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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.

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.

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CardioCel 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 device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut, flat sheet of acellular collagen. CardioCel has a shelf life of 24 months when stored between 2°C - 25°C. CardioCel is supplied in three sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm.

The acceptance criteria for the CardioCel device, a cardiovascular patch, are implicitly established by demonstrating substantial equivalence to predicate devices (Edwards Bovine Pericardial Patch K082139 and CV Peri-Guard Cardiovascular Patch K971726) through various studies. The device aims to meet performance characteristics related to mechanical strength, biocompatibility, and clinical safety and efficacy in cardiac repair.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria (e.g., minimum burst strength in MPa) are not explicitly stated, the criteria are inferred from the need to be "substantially equivalent" to predicate devices. The reported performance suggests the device meets these inferred criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Clinical Study: 30 pediatric patients.
  • Non-Clinical Studies (Animal): Information on the exact number of animals in the sheep model for pivotal studies is not provided, but it states "small and large animal models."
• Data Provenance:
  • Clinical Study: Not explicitly stated, but the sponsor is Australian (Admedus Regen Pty Ltd). This suggests the study might have been conducted in Australia or internationally, but the country of origin of the data is not specified.
  • Clinical Study Type: Prospective (implied by "A clinical study... was undertaken to assess the safety and efficacy").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document describes a clinical study of 30 pediatric patients but does not specify the number of experts used to establish ground truth (e.g., for assessing outcomes, efficacy, or adverse events).
• Qualifications of Experts: Not specified. Decisions in such clinical studies would typically be made by medical professionals (e.g., cardiac surgeons, cardiologists) involved in the care of the patients and evaluation of the device.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set in either the clinical or non-clinical studies. Outcomes would have been assessed by the clinical investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done or mentioned. This type of study is more common for diagnostic imaging devices rather than implantable patches. The comparison is made against existing predicate devices and literature.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical implant (cardiovascular patch), not an algorithm or software. Therefore, no standalone algorithm-only performance study was conducted. Performance is assessed through bench tests, animal studies, and human clinical trials.

7. Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study would be based on clinical outcomes data (e.g., successful repair, absence of complications, sustained hemodynamic properties, absence of calcification), assessed by medical professionals during follow-up (up to 36 months).
• Non-Clinical (Animal) Studies: Pathology (e.g., tissue remodeling, calcification assessment) and physiological outcomes data (e.g., durability, preservation of valve function in the specific defect models) would serve as ground truth, observed and evaluated by veterinary researchers and pathologists.
• Bench Testing: Direct measurement against engineering specifications and comparative data from predicate devices.

8. Sample Size for the Training Set

• The concept of a "training set" is typically associated with machine learning algorithms. Since this is a medical device (implantable patch), there isn't a traditional "training set" in the computational sense.
• The development and optimization of the CardioCel device and its ADAPT® TEP technology (which likely involved iterative testing and refinement) would represent an analogous "training" phase, but specific sample sizes for this development process are not provided in the summary. For instance, the number of bovine pericardial samples processed or animals used in early-stage development is not detailed.

9. How the Ground Truth for the Training Set Was Established

• Again, since this is not an AI/ML device, the concept of "ground truth for a training set" as it applies to algorithms is not directly relevant.
• However, the development and refinement of the ADAPT® TEP technology itself would have been guided by extensive R&D, where the "ground truth" would have been established through:
  • Biochemical and mechanical characterization: Lab experiments to optimize crosslinking, removal of cellular components, and achieve desired physical properties.
  • Early animal studies: To assess initial biocompatibility, degradation, and performance, leading to iterative improvements in the manufacturing process.
  • These iterations would inform the "training" (i.e., optimization) of the manufacturing process to produce the final device.

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