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The Dideco D903 Avant Hollow Fiber Oxygenator is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation . It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patients' veins during normal operation to assure the proper oxygenation capability of the device. The D903 Avant is intended to be used for six hours or less.

The Dideco D903 Avant membrane oxygenator is a high efficiency membrane oxygenator of hollow fiber design with an integral heat exchanger and an attached hardshell cardiotomy/venous reservoir. The device will be available both as an integrated device and as separate devices; a single sterile oxygenator module and the venous/cardiotomy reservoir. The fiber bundle within the oxygenator consists of a polycarbonate core wound with microporous polypropylene hollow fibers. The core is encapsulated on both ends with polyurethane and contained within a polycarbonate housing. Two versions of the oxygenator will be offered in two configurations having different affective gas exchange surface. The first has an effective gas exchange surface of 1.6 m², while the latter has an effective gas exchange surface of 2.0 m². The integral heat exchanger is comprised of a grooved and plated stainless steel sheet. The hardshell cardiotomy/venous reservoir of the integrated version is attached to the top of the oxygenator by means of a molded fitted joint and is comprised of a rigid polycarbonate housing with an internal support. The filtering system surrounds the internal support. Suctioned blood enters the cardiotomy section by two rotatable turrets equipped with %" and 1/2" connectors. The blood enters the reservoir by gravity drainage from the cardiotomy, through the venous inlet placed in the bottom of the reservoir or by means of a recirculation line (allowing oxygenated blood to be recirculated and purged back to the reservoir). A self-purging four-way stopcock located beside the oxygenation module of the D903 Avant allows for arterial and venous blood sampling. The blood sampling system consists of three coiled PVC tubes connected to a four-way stopcock. The tubes allow for either sampling or purging of arterial and venous blood or delivery of drugs into the venous line. The D903 Avant includes arterial and venous temperature probe sites for monitoring of blood temperature. A holder is available for use with the oxygenator. The holder is comprised of a stainless steel rotating arm secured to the IV pole by means of a knob. This allows for independent rotation of the device. On the bottom of the holder are two integrated Hansen water connectors securing the Oxygenator in a locked position.

Acceptance Criteria and Study for D903 Avant Hollow Fiber Oxygenator

The D903 Avant Hollow Fiber Oxygenator underwent a series of in vitro and clinical studies to demonstrate its performance and substantial equivalence to a predicate device (MONOLYTH Oxygenator). The acceptance criteria were largely based on comparison to this predicate device and conformance with the proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators.

1. Table of Acceptance Criteria and Reported Device Performance

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

• In vitro studies: The sample sizes for individual in vitro tests are not explicitly stated. However, the studies were performed by Dideco S.p.A. in Italy, indicating a European origin for the data. These were laboratory-based tests comparing the D903 Avant to the predicate device.
• Clinical studies: A total of ten patients were used. The country of origin for the clinical data is not explicitly stated, but given that Dideco S.p.A. is based in Italy, it is highly probable the clinical studies were conducted there. The data is prospective, as it involved patients undergoing cardiopulmonary bypass surgery using the D903 Avant.

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

This information is not provided in the summary. For the in vitro studies, specific expert consensus is less relevant as performance metrics are often objective and measurable against standards or predicate devices. For the clinical studies, patient outcomes represent the "ground truth" for safety and efficacy in a clinical setting, which would be evaluated by treating physicians and medical teams, but no formal "expert panel" is mentioned for establishing ground truth for the test set itself.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessments, especially in imaging or diagnostic device evaluations where multiple readers might interpret results. This type of adjudication method is not applicable and therefore not mentioned for this device, which focuses on objective physiological measurements, gas exchange capabilities, and mechanical integrity as compared to a predicate device and existing standards.

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

An MRMC comparative effectiveness study was not conducted, nor is it relevant given the nature of the device (oxygenator) and the types of performance metrics evaluated. The device is not an AI-assisted diagnostic tool where human readers' performance would be compared with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (in vitro performance and clinical studies on patients) was performed.

• The in vitro studies directly evaluated the algorithm/device's performance (gas transfer, pressure drops, hemolysis, etc.) against established benchmarks and the predicate device.
• The clinical studies assessed the device's performance in humans without explicit mention of human-in-the-loop interaction for performance correction beyond the standard operation of an oxygenator by a perfusionist.

7. Type of Ground Truth Used

• In vitro studies: The ground truth was established by objective measurements compared to:
  • Proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators.
  • Performance characteristics of a legally marketed predicate device (MONOLYTH oxygenator).
• Clinical studies: The ground truth was based on patient physiological parameters and outcomes (e.g., arterial and venous blood gas levels, hematological data) during and after cardiopulmonary bypass, as monitored by standard clinical practice.

8. Sample Size for the Training Set

The concept of a "training set" with ground truth is primarily relevant for machine learning or AI-based devices. This medical device is a physical product (oxygenator), not an AI algorithm. Therefore, no distinct "training set" in the machine learning sense was used or reported. Device design and optimization would have relied on engineering principles, material science, and iterative testing, rather than an AI training set.

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

As noted above, there was no "training set" in the context of an AI algorithm. The device's design and optimization were based on:

• Engineering specifications and principles for cardiopulmonary bypass equipment.
• Knowledge of physiological requirements for blood oxygenation and CO2 removal.
• Comparison with existing predicate devices to understand desirable performance characteristics.
• Internal testing and refinement processes during product development, guided by standards like the AAMI-ISO Draft Standard.

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