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CryoValve® SG Pulmonary Human Heart Valve (and Conduit) 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 cells and cellular debris that has not already been removed during the postmonten, and harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium, cretaining a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system nonly 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 Human Heart Valve (and Conduit). This submission is for a medical device and not an AI/ML powered device. As a result, the requested information (performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) specific to AI/ML device evaluations is not applicable and not present in the document.

The document focuses on:

• Intended Use: Replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, including use in the Ross Procedure.
• Predicate Devices: Mentions previous 510(k) clearances (K033484 and K083106) for similar CryoValve® SG devices.
• Device Description: Details on aseptic recovery, antimicrobial treatment, cell and cellular debris removal, cryopreservation, packaging, and supercooling process. It also mentions reduced risk for HLA class I and class II alloantibodies compared to standard-processed valves.
• Scientific Evidence and Bench Testing: States that scientific analysis and testing were conducted to change the device shelf life, including biomechanical properties testing, pulsatile flow characterization, and accelerated wear testing. It refers to "theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures."

Since this is not an AI/ML device, the specific questions related to AI/ML acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) cannot be answered from the provided text.

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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:

1. 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.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 as this is not an AI/ML device.
6. 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.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. 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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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:

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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