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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

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

The document does not explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

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 to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety tests.

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 is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is an oxygenator, not an algorithm.

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

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

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 device.

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The VitalFlow™ Console controls the VitalFlow™ Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients 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. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.

The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal life support (ECLS) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for ECLS circuit data only; no patient data are stored or exported.

The VitalFlow Emergency Handcrank (drive unit) can be used in emergency situations to manually drive the centrifugal pump in the case of console and or motor drive failure.

The provided text describes the VitalFlow™ Console, an extracorporeal circuit component, and its FDA 510(k) clearance (K230364). The document outlines the device's indications for use, description, and the performance evaluations conducted to demonstrate substantial equivalence to a predicate device.

However, the document does not contain the detailed information necessary to answer all parts of your request, specifically regarding acceptance criteria for an AI/ML model, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details for an AI model. This is likely because the VitalFlow™ Console is a mechanical/electronic medical device, not an AI/ML-driven diagnostic or assistive device that would typically undergo such evaluations.

The "Bench Performance Evaluations" section lists various studies (Hydraulic performance, Reliability, EMC, Electrical Safety, Software Validation, Usability Studies), but these are standard engineering and regulatory tests for hardware and software functionality, not AI model performance.

Therefore, I cannot provide a table of acceptance criteria for an AI model or details about AI-specific testing from this document.

If you are looking for information regarding an AI/ML-driven medical device, this document does not seem to pertain to such a device.

From the provided text, I can infer the following about the device and its testing:

• Device Type: The VitalFlow™ Console is an extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure (Product Code: QNR, Regulation Number: 21 CFR 870.4100). It controls features like pump motor speed (RPM), flow, and bubble detection.
• Purpose of Studies: The studies were conducted to demonstrate "substantial equivalence" of the VitalFlow™ Console to a predicate device (TandemHeart Escort Controller, K202751) and to meet the "Special Controls" described in 21 CFR 870.4100.
• Nature of Studies: The studies were primarily "Bench Performance Evaluations" and included aspects like hydraulic performance, reliability, EMC, electrical safety, software validation, and usability studies. These are typical engineering and functional performance tests for a physical device.
• Ground Truth: For a physical device like this, "ground truth" would be established through calibrated instruments and established engineering principles for parameters like flow rate, RPM, pressure, and electrical safety. It's not based on expert consensus on image interpretation or pathology.
• No AI Component: There is no mention of an AI/ML component or algorithm within the VitalFlow™ Console. Therefore, concepts like training sets, test sets for AI models, expert adjudication, or MRMC studies are not applicable to the information provided.

In summary, the provided document does not contain the information requested about AI/ML device acceptance criteria and study details because the VitalFlow™ Console appears to be a physical medical device, not an AI-driven one.

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