(109 days)
CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosihetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed.
Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.
The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve SG) is a human hent valvai The Cryolitie, fice C. you ve 35 Friman I. The valve is dissected, treated with an antimierobial solution, and asepted to remove the cells and cellular debris that has not already been removed during the posimorlem treated to renove the centual deenses. The valve is cryopreserved in a tissue vulture medium. period. hervesting, and the antitional process. The thee pouch packaging system. The packaging containing a cryqptolection, within the meether allows for aseptic introduction of the valve into the system not only while the lemperatures, our in begin prior to crystallization to feel have arm operating tolin. Supercenting of informations are transferred to a liquid nitrogen freezer for long-lerm storage at -- 135°C to -196°C.
Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA chass Implantion of the CTS varve SCF Camend Reactive Amibody measured at up to one year. Compared to the I and citiss II and mobile is misser on theat valve. Data have not been provided to evaluate the effect of standard-processed punnolary in the United United Online Form durability, or long-term resistance to rejection by the patient, of the CryoValve SG.
The provided document is a 510(k) summary for the CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit, a human heart valve. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.
The "Analysis Supporting Substantial Equivalence" section states: "A Clinical Data Analysis provides the needed assessment to support the product claim. The Analysis reviews A Cinnell Dall Analysis provides the necesses scientific rationale needed to make this change to the labeling." This vague statement implies a clinical data analysis was performed, but no details of this analysis are provided in the document. The document primarily focuses on regulatory clearance based on substantial equivalence to a previously cleared predicate device (K033484).
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document is about a heart valve, not an AI/ML device with performance metrics like sensitivity/specificity.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document is a regulatory submission for a medical device (human heart valve) which is substantially different from an AI/ML software device that would typically undergo performance evaluation against specific acceptance criteria.
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