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This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. Medtronic Tubing Packs consist of coated and uncoated tubing, connectors and various medical devices that are pre-assembled into user-specified extracorporeal cardiopulmonary bypass perfusion circuits. Tubing Packs are intended for use within the extracorporeal blood pathway during cardiopulmonary bypass surgical procedures. Medtronic Tubing Packs are currently packaged into qualified clear tray and sterile packaging systems. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components.

This looks like information for a regulatory submission for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set in quantitative terms (e.g., number of units tested). Instead, it mentions that "worse case testing for tubing and connectors" was performed and "verification results were leveraged based on most challenging components." This suggests that a subset of components representing the most challenging scenarios was selected for testing.

The data provenance is from Medtronic, Inc.'s internal testing. It is prospective in the sense that the testing was conducted specifically for this submission to verify the performance of the added components. The country of origin of the data is implicitly the United States, as Medtronic is based there and submitting to the FDA.

3. Number of Experts and Qualifications for Ground Truth

This device (Medtronic Tubing Pack) is a Class II medical device, specifically "Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing." The "ground truth" in this context refers to established engineering and biocompatibility standards and performance requirements for such medical components, rather than clinical interpretation by medical experts (like radiologists for imaging devices).

The document does not mention the use of experts to establish a "ground truth" for a test set in the way one would for an AI-powered diagnostic device. The "ground truth" for this device's performance is derived from established industry standards, internal product specifications, and regulatory requirements that define acceptable limits for pressure integrity, biocompatibility, etc. The document refers to "product specification" and "rationalization documentation" as the basis for evaluation.

4. Adjudication Method

An adjudication method (like 2+1, 3+1) is typically used in clinical studies where there's a need to resolve discrepancies in expert opinions on imaging or clinical assessments. For this type of device (tubing and connectors), the "adjudication" is based on objective measurement against predefined specifications and standards. There is no mention of human adjudication in the traditional sense for reconciling expert interpretations for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging, to assess improvements in reader performance with AI assistance. This device is a passive component for cardiopulmonary bypass and does not involve human interpretation in a diagnostic capacity or AI assistance.

6. Standalone Performance Study

The studies described are essentially standalone performance studies for the device components. The verification and validation testing assesses the "algorithm only" (if one considers the manufacturing process and design as the "algorithm" for a physical device) against predetermined performance specifications. The tests for pressure integrity, spallation, kink resistance, pull force, tubing life, and biocompatibility are all evaluations of the device's inherent performance characteristics without human interaction being part of the primary performance metric.

7. Type of Ground Truth Used

The ground truth used is primarily engineering specifications, material science standards, and biocompatibility standards, as outlined in the "product specification" and various "rationalization documentation" (e.g., Mechanical Requirements, Coating Requirements, Biocompatibility per product specifications). Essentially, the "ground truth" is established industry and regulatory benchmarks for the safety and efficacy of cardiopulmonary bypass components.

8. Sample Size for the Training Set

This document does not mention a "training set" as this is not an AI/machine learning device. The "training" for a physical medical device typically refers to the design, manufacturing process, and quality control procedures, which are developed and refined over time based on engineering principles and previous device iterations. There isn't a "training data" set in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/machine learning sense, there is no ground truth established for it. The development and refinement of the device's design and manufacturing processes (analogous to "training" for a physical product) would be based on:

• Engineering design principles
• Material science knowledge
• Previous iterations of similar devices (predicates)
• User feedback
• Regulatory requirements and standards for medical devices.

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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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