(21 days)
CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.
The Cryor atch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period, harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing cryoprotectants, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.
CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.
The provided text describes the CryoPatch SG Pulmonary Human Cardiac Patch, a medical device, and its 510(k) clearance. However, it does not contain information about formal acceptance criteria from a study, nor does it detail a study that explicitly proves the device meets specific performance criteria in the way you've outlined.
The document primarily focuses on the regulatory clearance process, establishing substantial equivalence to predicate devices based on:
- Device Description: What the device is made of and how it is processed.
- Intended Use: What the device is used for.
- Predicate Devices: Other similar devices already on the market.
- Scientific Evidence and Bench Testing: This section mentions types of tests conducted to support a change in device shelf life, specifically:
- Biomechanical properties testing
- Pulsatile flow characterization
- Accelerated wear testing
- Theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures.
Crucially, it does not provide the specific numerical acceptance criteria (e.g., "tensile strength must be > X MPa") for these tests, nor does it report the results of these tests against such criteria. It also does not involve human subjects, expert review, or ground truth establishment in the manner typically associated with AI/diagnostic device studies.
Therefore, I cannot populate your requested table and answer many of your questions in the way you've phrased them, as the information is not present in the provided text.
Based on the available text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| (e.g., specific thresholds for biomechanical properties, pulsatile flow, or accelerated wear) | The document states "scientific analysis and testing...were conducted to change the device shelf life" and mentions "theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures." No specific performance numbers or comparison to criteria are provided. |
2. Sample size used for the test set and the data provenance
The document discusses bench testing on the device itself (tissue, patch), not a clinical 'test set' in the context of human data or AI. Therefore, these questions are not applicable to the provided text.
- Sample size for test set: Not applicable (bench testing, not a clinical test set).
- Data provenance (country of origin, retrospective/prospective): Not applicable. The testing is described as scientific and bench testing, likely conducted in-house by CryoLife, Inc. (USA-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable. The data is from bench testing of a physical device, not from human studies requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No human interpretation or adjudication for a test set is mentioned.
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 or diagnostic device study. It's a regulatory submission for a physical tissue graft.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the human data sense. The "truth" for the bench tests would be the measured physical properties and histological observations of the tissue after storage and wear simulation.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI study.
9. How the ground truth for the training set was established
Not applicable.
§ 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).