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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:

1. Device Description: What the device is made of and how it is processed.
2. Intended Use: What the device is used for.
3. Predicate Devices: Other similar devices already on the market.
4. 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

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.

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CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

The CryoPatch® 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 a cryoprotectant, 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 does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found in device performance studies for AI/software devices.

Instead, this document is a 510(k) summary for a human cardiac patch (CryoPatch® SG Pulmonary Human Cardiac Patch), which is a physical biological device, not an AI or software model. The "studies" mentioned refer to evaluations of the biological and mechanical properties of the patch, and its substantial equivalence to predicate devices, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for an AI system.

Here's a breakdown of why this document doesn't fit the requested criteria and what information it does provide:

1. A table of acceptance criteria and the reported device performance: This is not present for performance metrics. The document states: "CryoPatch SG has undergone biomechanical, histological, DNA content, and decellularization evaluation. In addition, a large animal study and clinical data support the substantial equivalence of the device to previously marketed devices." These are general categories of testing, not specific acceptance criteria with quantifiable outcomes. The closest to a "performance metric" is the statement regarding HLA class I and class II alloantibodies: "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." However, no specific acceptance threshold or numerical performance is given.

2. Sample sized used for the test set and the data provenance: No information on sample sizes for specific tests is provided, nor data provenance in terms of country of origin or retrospective/prospective nature for these evaluations. It mentions "clinical data" and a "large animal study" generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical patch would likely be established through laboratory analyses, animal models, and clinical follow-up by medical professionals (surgeons, pathologists), but the document does not detail this process in the context of "experts" as in AI ground truth assessment.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device where human readers would interpret outputs.

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: For a physical medical device like this, "ground truth" would be established through:

   • Histological, DNA content, and decellularization evaluations: These are laboratory analyses using established scientific methods to assess the tissue's properties.
   • Large animal study: In vivo performance in an animal model.
   • Clinical data: Outcomes in human patients.
     The document doesn't provide specifics on how this ground truth was used to establish criteria or measure performance against them.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a physical medical device (a human cardiac patch) and its 510(k) clearance summary. It focuses on demonstrating substantial equivalence to predicate devices through various biological and biomechanical testing, animal studies, and clinical data, rather than meeting acceptance criteria for an AI or software device's performance.

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