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The VitalFlow Set with Balance Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

VitalFlow Sets with Balance™ Biosurface contain components used to prepare an extracorporeal circuit for ECMO procedures. The components include the VitalFlow Tubing Sets packaged together with the legally marketed Nautilus VF Oxygenator and VitalFlow Centrifugal Pump as a standard kit. The components are connected together to prepare an extracorporeal circuit for ECMO procedures.

The VitalFlow Tubing Set contains a preassembled drainage and return loop "ECMO Circuit," tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The tubing assembly is provided pre-connected to the inlet of the VitalFlow Centrifugal Pump. The "Priming Circuit" contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit.

This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

The Medtronic VitalFlow™ Set with Balance™ Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours for adults with acute respiratory or cardiopulmonary failure. The acceptance criteria and supporting study details are as follows:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VitalFlow Set with Balance Biosurface primarily focus on demonstrating substantial equivalence to a predicate device and ensuring acceptable performance through pre-clinical bench testing and real-world clinical evidence. While explicit numerical acceptance criteria for many mechanical and biocompatibility tests are not provided in the summary, the overall conclusion is that the device "does not raise different questions of safety or effectiveness" compared to the predicate. The clinical summary provides comparative performance data for complications.

• Oxygenator Failure (Prevalence): VitalFlow Set: 4.6% (9/195) vs. All other ECMO Systems: 8.0% (4878/61176).
• Oxygenator Failure (Rate per 1000 Hrs): VitalFlow Set: 0.30 vs. All other ECMO Systems: 0.35.
• Pump Failure (Prevalence): VitalFlow Set: 2.6% (5/195) vs. All other ECMO Systems: 0.6% (368/61176).
• Pump Failure (Rate per 1000 Hrs): VitalFlow Set: 0.16 vs. All other ECMO Systems: 0.02.
• Thrombosis/Clots in Circuit Component: VitalFlow Set: 1.0% (2/195) vs. All other ECMO Systems: 2.1% (1272/61176).
  Hemolysis:
• Moderate or Severe Hemolysis: VitalFlow Set: 2.1% (4/195) vs. All other ECMO Systems: 5.2% (3197/61176).
  (Other specific complication rates are listed in the table in the document and generally show comparable or lower rates for VitalFlow Sets, with the exception of pump failure prevalence and rate). |
  | Labeling | Include detailed summary of non-clinical evaluations, instructions for anticoagulation, circuit setup, performance, and maintenance. | Instructions for Use include the required details. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Clinical "Test Set": 195 patients (VitalFlow Set group).
• Data Provenance: The data comes from a "summary of real-world evidence (195 reports) of the clinical experience with the VitalFlow Set from the ELSO Registry." This indicates the data is retrospective and derived from a registry, which typically collects data from multiple institutions/countries. The specific country of origin is not explicitly stated but the ELSO Registry is an international organization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical complication data from the ELSO Registry. Registry data often involves reporting by treating clinicians, and data validation/adjudication processes vary by registry but are not detailed here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical complication data from the ELSO Registry. It is implied that the reported complication rates are based on the data as collected and recorded within the registry.

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

No MRMC comparative effectiveness study was mentioned. The study evaluates the device's performance in a real-world setting rather than comparing human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable as the device is a medical device (extracorporeal circuit components) and not an AI algorithm. Its performance is inherent to its mechanical and biological functions, not an algorithm's output.

7. Type of Ground Truth Used

The ground truth for the clinical performance data (complication rates) is based on real-world outcomes data collected and reported to the ELSO Registry. For the pre-clinical tests, the ground truth would be established by validated test methods and engineering specifications.

8. Sample Size for the Training Set

This question is not applicable as the device is not an AI algorithm requiring a training set. The "training set" concept does not apply to the development and evaluation of this type of medical device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated above.

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The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardion is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of bxvgenated blood/cardioplegia solution in a predetermined rationulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

The Cortiva coated and Uncoated MYOtherm XP™ Cardioplegia Delivery System is designed to mix arterial blood from an oxygenator with sanguineous cardioplegia solution in specific ratios, depending upon the system chosen. The patient delivery line is packaged separately to allow for ease of sterile transfer to the operative field prior to connection to the delivery outlet of the cardioplegia system. A pressure monitoring line, three-way stopcock, and gauge protector, as well as a pressure relief line with pressure relief valve are preconnected.

The Cortiva coating is a BioActive Surface that is non-leaching and provides thromboresistant blood contact surface. The A10378001, CBXP41 and the CBXP41B MYOtherm Cardioplegia Delivery Systems are identical except for the bypass loop. The XP41B and CBXP41B contains a bridge between the blood and crystalloid line allowing the physician to deliver 100% blood, if needed.

The male-to-male Luer connector component 61399405213 that is the 'subject' of this special 510(k) connects with MYOtherm via a pressure relief valve and tubing. 61399405213 gets connected to a pressure relief valve on one end, and a cap on the other end. A perfusionist can remove the cap to connect a PVC tubing of choice, during Cardioplegia intervention.

This document K240190 describes a Special 510(k) submission for the Medtronic MYOtherm XP™ Cardioplegia Delivery System. The submission focuses on a change in the polycarbonate resin used in a component (connector 61399405213).

Therefore, the acceptance criteria and study described pertain to the biocompatibility of the device with the new resin formulation, rather than a clinical performance study involving AI or human readers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of animals for in vivo tests, number of samples for in vitro tests) used for each biocompatibility test. It only states that "The samples built for the testing included the connector component with proposed resin formulation."

The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, biocompatibility testing is typically conducted in a laboratory setting under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

This information is not applicable to a biocompatibility study. Biocompatibility tests follow established ISO standards, and the "ground truth" is determined by the specific biological reactions observed against predetermined criteria for each test. These results are usually interpreted by qualified toxicologists or biologists, but the document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

This is not applicable to biocompatibility studies, which rely on objective measurements and established pass/fail criteria according to international standards (e.g., ISO 10993 series).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is focused on the biocompatibility of a material change in a medical device, not on diagnostic accuracy involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI software.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on the objective biological and physiochemical responses observed in the standardized biocompatibility tests. These tests assess potential adverse biological effects such as cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, and hemostatic changes, according to recognized international standards (e.g., ISO 10993).

8. The Sample Size for the Training Set

This is not applicable as this study is a biocompatibility assessment of a material change, not a machine learning model. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of study.

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The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.

The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.

The provided text describes a medical device, "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface" and its substantial equivalence submission to the FDA. The information focuses on regulatory compliance, device characteristics, and performance data from pre-clinical bench studies.

Based on the provided text, the device is a Class II medical device (Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure). The device does not involve AI. Therefore, the questions related to AI-specific performance criteria, test sets, ground truth, experts, and human-in-the-loop performance are not applicable.

Here's the information that can be extracted:

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

The acceptance criteria are derived from the "Special Controls" identified in 21 CFR 870.4100, as outlined by the FDA Final Order 81 FR 7451, February 12, 2016. The reported device performance is a statement of compliance with these controls, supported by various bench studies.

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

The text mentions "pre-clinical bench studies" for performance testing. Specific sample sizes for each bench test are not provided. The testing is conducted by Medtronic, a US-based company, implying the studies were conducted internally or through contracted labs, but the specific country of origin for the data is not explicitly stated. The studies are described as "pre-clinical bench testing," which are inherently controlled laboratory experiments, not reflecting a "retrospective or prospective" study design in the clinical sense.

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. This is a physical medical device clearance based on bench testing of its mechanical, material, and functional properties, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth.

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

Not applicable, as this refers to expert adjudication in diagnostic studies, not bench testing of a physical device.

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. The device does not involve AI.

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

Not applicable. The device does not involve AI.

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

For the non-clinical performance evaluation, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications for properties like durability, tensile strength, pressure resistance, kink resistance, blood trauma, and coating coverage. The "truth" is whether the device meets these pre-defined physical and functional requirements.

8. The sample size for the training set

Not applicable. The device does not involve AI, therefore there is no "training set."

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

Not applicable. The device does not involve AI.

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