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The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.

The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.

Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.

Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.

The document provided does not describe a study involving device performance, diagnostic accuracy, or clinical outcomes that would typically include acceptance criteria, sample sizes for test and training sets, expert involvement, or adjudication methods.

Instead, this is a 510(k) premarket notification for a medical device (MVR™ Venous Reservoir Bag) which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "Summary of Testing" section describes biocompatibility testing and a design assessment related to a material change in a component (one-way stopcock) of the device.

Therefore, many of the requested categories (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for performance, training set sample size/ground truth establishment) are not applicable to the information presented in this document.

However, I can provide the available information related to the biocompatibility testing and design assessment.

1. Table of Acceptance Criteria and Reported Device Performance (for Biocompatibility and Design Assessment):

Given the nature of the document, the "performance" here refers to meeting biocompatibility standards and
the assessment that functional performance is unaffected.

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

• Biocompatibility Testing: The document does not specify exact sample sizes for each biological endpoint test. It references compliance with ISO 10993 and USA FDA Guidance Document on Use of ISO 10993-1 standards, which typically outline specific sample size requirements for each test.
  • Data Provenance: The tests for the device component were either conducted by Medtronic (or a contracted lab) or referenced from a supplier certificate. The reference device data ("Step™ Auto Suture™ Dilator and Cannula") was applied, suggesting internal company data or previous submissions. The supplier certificate indicates tests were conducted "in accordance with 'Good Laboratory Practice'". This appears to be prospective testing for regulatory submission. Country of origin for data is not specified beyond being part of a US FDA submission process.
• Design Assessment: No specific sample size is discussed as it was a qualitative assessment.

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

• Not Applicable in this context. The biocompatibility tests are laboratory-based, with "passing" results determined by established scientific/regulatory standards rather than expert consensus on a ground truth. For the design assessment, no specific number or qualification of experts is mentioned; it's a statement of internal engineering/design conclusion.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the results are determined by objective laboratory test outcomes against established Pass/Fail criteria, not by human adjudication of observations or interpretations.

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 physical medical device (venous reservoir bag) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used:

• For Biocompatibility: The "ground truth" is defined by the objective pass/fail criteria of the specified ISO 10993 and USP Class VI biological endpoint tests (e.g., no significant cytotoxicity, no sensitization, no systemic toxicity, etc.).
• For Design Assessment: The "ground truth" is the engineering assessment that the material change has no impact on the functionality or performance of the final product.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility tests are evaluative, not for training.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The provided document is a 510(k) summary for the Medtronic CardioTherm™ Blood Cardioplegia Delivery Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner one might expect for a novel diagnostic or AI-driven device.

Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission. This document details a comparison of general characteristics and nominal specifications to establish substantial equivalence.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of defined metrics and thresholds for a specific performance study. Instead, it presents a comparison of the Medtronic CardioTherm™ Blood Cardioplegia System's characteristics and specifications against four predicate devices to demonstrate substantial equivalence. The "performance characteristics" listed are:

The "acceptance criteria" for this type of submission are implicitly that the new device's characteristics and performance are comparable to, or within the established safety and effectiveness profile of, the predicate devices. The document argues that this is the case, stating, "The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other These predicate/marketed Blood Cardioplegia Systems currently in commercial distribution."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is a comparison of product specifications and intended use, not a clinical trial or performance study on a test set of data.

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)

This information is not applicable as there is no mention of a test set requiring expert-established ground truth. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and market history.

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

This information is not applicable as there is no test set or adjudication process described.

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

This information is not applicable. The device described is a medical instrument (blood cardioplegia delivery system), not an AI-driven diagnostic tool. Therefore, there are no "human readers" or AI assistance involved in its function or evaluation in the context of this submission.

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

This information is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices as previously cleared by regulatory bodies. The submission aims to demonstrate that the new device is "substantially equivalent" to these already-marketed devices, implying it meets similar safety and performance standards.

8. The sample size for the training set

This information is not applicable as the device is not an AI system that requires a training set.

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

This information is not applicable for the same reason as above.

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