(1556 days)
CryoValve SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic 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 (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial · solution, and treated to remove the cellular debris that has not already been removed during the postmortem period, harvesting, and the antimicrobial process. The valve 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 ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.
The provided text describes a 510(k) summary for the CryoValve® SG Pulmonary Valve and Conduit, a human heart valve allograft. However, the document does not contain information regarding
acceptance criteria in the way it is typically described for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through preclinical bench, animal testing, and clinical evaluation.
Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text, as this medical device is a human tissue allograft, not an AI/ML driven device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable for this type of device in the context of AI/ML or specific quantitative performance metrics like sensitivity/specificity. | CryoValve SG was found to be comparable to the predicate CryoValve in terms of biocompatibility, integrity, and mechanical performance. This comparability provides reasonable assurance of device performance for its intended use and supports a determination of substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided document. The clinical evaluation is mentioned, but no details on sample size are given.
- Data Provenance: Not specified. The document mentions "clinical evaluation" but doesn't detail the nature, retrospective/prospective design, or geographic origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The "ground truth" for this device would likely be derived from a combination of clinical outcomes, histological analysis (for biocompatibility), and mechanical testing, rather than expert consensus on diagnostic images.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set:
- Not applicable/not specified.
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:
- No. This is not an AI/ML device, so an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used:
- Based on the general context of medical device approval for allografts, the "ground truth" or evidence demonstrating safety and effectiveness would likely include:
- Clinical Outcomes Data: From the "clinical evaluation" mentioned, demonstrating patient outcomes after implantation.
- Biocompatibility Testing: Ensuring the material does not cause adverse biological reactions.
- Integrity and Mechanical Performance Testing: Bench and animal testing to assess the structural soundness and functional performance of the valve under simulated physiological conditions.
- Histological and Microbiological Analysis: To confirm tissue quality, cell removal, and sterility.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device. The "training" here would refer to the historical data and experience with the predicate device (CryoValve) rather than a defined training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. Any "ground truth" related to the predicate device would have been established through its own preclinical and clinical evaluations, which preceded this 510(k) submission. The current submission focuses on demonstrating comparability between the new device and the existing predicate.
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