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Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.

Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.

These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.

The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).

The provided document is an FDA 510(k) approval letter for the VANGUARD Blood Cardioplegia Systems. It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested sections regarding acceptance criteria, new study design, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable to this type of regulatory submission and are not present in the document.

The document emphasizes a non-clinical performance evaluation to demonstrate equivalence, primarily focusing on material changes and updated technical specifications, without conducting new clinical trials.

Here's an analysis based on the provided text, indicating where information is not present or not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, there are no explicit "acceptance criteria" defined as performance metrics that the device must meet in a novel clinical trial. Instead, the "acceptance" is based on demonstrating that the modified devices perform equivalently to the existing, cleared predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document explicitly states: "No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems..." (Page 7).
• The "test set" for performance evaluation was based on non-clinical verification and validation testing. The specific sample sizes for these tests (e.g., number of devices tested for material compatibility, flow rates, temperature regulation, etc.) are not detailed in this summary document.
• Data provenance is also not specified regarding country of origin or whether it was retrospective/prospective, as it pertains to internal lab testing for device verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Since no clinical testing was performed, there was no need for experts (e.g., radiologists) to establish a clinical "ground truth" for a test set. The validation was based on engineering and performance criteria against standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. As there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

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 device is a hardware system (cardioplegia set), not an AI/software device. No MRMC study was done, and the concept of "human readers improving with AI assistance" is irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical performance data, the "ground truth" (or reference) would be engineering specifications, regulatory standards, and the established performance characteristics of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set for this device.

Summary regarding the Study:

The "study" that proves the device meets the (implied) acceptance criteria is a non-clinical verification and validation testing program. This means the manufacturer conducted a series of tests in their labs to ensure the modified device functions as intended, meets design specifications, is biocompatible with the new materials, and performs equivalently to the predicate devices, all in accordance with relevant national and international standards. This type of evidence is common for 510(k) submissions, particularly when changes are made to materials or manufacturing processes of existing device types where substantial equivalence can be demonstrated without new clinical data.

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The Vision Blood Cardioplegia is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic of hypothermic applications.

The Vision Blood Cardioplegia consists of an extracorporeal heat exchanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to affect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross particulate filter (105 m) and pressure relief device designed to open in the event of excessive fluid pressure (600 mmHg) during use. Solutions are delivered to the patient through the extension line and appropriate cannula. Blood flow is driven by a roller pump connected through the extension line.

The provided text describes a 510(k) submission for the "Vision Blood Cardioplegia and Extracorporeal Heat Exchanger" and provides a summary of the device, its indications for use, and a statement about testing. However, it does not include specific acceptance criteria or detailed study results that prove the device meets those criteria.

The document states:
"The Vision Blood Cardioplegia has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies to applicable industry and safety standards."

And concludes:
"The conclusion drawn from these tests is that the Vision Blood Cardioplegia is equivalent in safety and efficacy to its predicated devices."

This is a general statement that testing was done and a conclusion of equivalence was reached, but it does not provide the specifics requested in your prompt. Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as this is a medical device, not a diagnostic algorithm requiring expert ground truth in that sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the type of device and information provided.
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 a medical device (heat exchanger), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a device like this would typically involve engineering specifications, performance standards, and physiological measurements in animal or simulated models, but these specifics are not provided.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided text only offers a high-level assertion that testing was conducted and demonstrated equivalence to predicate devices, but lacks the detailed performance criteria and study specifics you requested.

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