(65 days)
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:
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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.
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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.
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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.
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Adjudication method for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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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.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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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.
§ 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).