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The Dideco D 903 Avant Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir 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 on other 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 to tient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

The D 903 AVANT and D 903 AVANT 2 Ph.I.S.I.O, hereafter referred to as the AVANT, are hollow fiber membrane oxygenators with integral heat exchanger and a hardshell cardiotomy/venous reservoir. The D 903 AVANT 2 Ph.I.S.I.O. is the phosphorylcholine coated version of the same AVANT oxygenator. The change covered by this submission is limited to extending the intended use of the AVANT (uncoated and coated versions) in order to allow the use of active venous drainage with vacuum. No modifications are being made to the devices themselves except an addition to the indications for use and instructions for use.

This is a 510(k) premarket notification for a medical device, the D 903 AVANT Adult Hollow Fiber Oxygenator. These notifications are about demonstrating substantial equivalence to a predicate device, not necessarily defining or proving new acceptance criteria through a clinical study in the way an AI/ML device submission would. Therefore, many of the requested categories for AI/ML study details (like sample size for test sets, number of experts, MRMC studies, training set details) are not applicable here.

Here's a breakdown of the available information in the context of your request:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate devices and the relevant standards. The "reported device performance" is a demonstration of substantial equivalence to these predicate devices.

• Performance characterization
• Physical effectiveness characterization/integrity |
  | Blood Compatibility (for coated version) | "Blood compatibility characterization and stability of the coating were performed on the AVANT Ph.I.S.I.O. predicate device (K020351)." This included "hemolysis/cell depletion characterization, microembolic activity characterization, and reservoir housing integrity during active venous drainage." "The results of these tests met established specifications." |
  | Intended Use with Vacuum Drainage | The submission specifically addresses the extension of intended use to include active venous drainage with vacuum. The above tests (e.g., reservoir housing integrity during active venous drainage) would cover this. "functional tests demonstrate that the AVANT is equivalent to the predicate devices, with respect to its intended use with vacuum drainage." |
  | Equivalence to Predicate Devices | "The results of the study showed the device characteristics of the modified AVANT and predicate devices are comparable." "The results of in vitro studies demonstrate that the AVANT Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the predicate device." |

Study Details (as applicable to a 510(k) for a non-AI/ML device)

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. This submission focuses on in vitro and biocompatibility testing of a physical medical device. The "test set" would refer to the physical samples of the oxygenator or its materials subjected to various tests. The provenance is the manufacturer's testing facilities (Dideco S.p.A., Italy).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by standardized laboratory measurements and compliance with ISO standards, not expert consensus in the diagnostic sense.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for subjective assessments or discrepancies in diagnostic interpretations, not for objective measurements of physical device performance.
4. 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 is for a physical medical device, not an AI/ML diagnostic algorithm.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international standards (ISO 10993-1:1995, ISO 7199 (1996)) and FDA guidance documents, as well as objective measurements of physical and chemical properties of the device and its materials.
7. The sample size for the training set: Not applicable. This is for a physical medical device, not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) premarket notification demonstrates substantial equivalence for a physical medical device based on in vitro performance data and biocompatibility testing, not an AI/ML diagnostic product, so many of the requested AI/ML-specific details are not present.

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The Dideco D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir 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 patient's veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

The D 903 AVANT Ph.I.S.I.O is a hollow fiber membrane oxygenator with integral heat exchanger and a hardshell cardiotomy venous reservoir.

Here's an analysis of the provided text regarding the acceptance criteria and study for the D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Oxygenator:

This document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study report describing novel performance claims. Therefore, the device is not demonstrating performance against acceptance criteria in the way an AI/ML device would. Instead, it is demonstrating substantial equivalence to existing devices through a series of tests. Many of the requested categories are not directly applicable to this type of submission.

The "acceptance criteria" here are implicitly that the D 903 AVANT Ph.I.S.I.O. performs equivalently or within acceptable ranges compared to its predicate devices for relevant characteristics. The "study" proving this is a series of in vitro and biocompatibility tests.

1. Table of "Acceptance Criteria" and Reported Device Performance

The following points are mostly not applicable to this type of device submission (a traditional 510(k) for an oxygenator, not an AI/ML diagnostic system):

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

• Sample Size: Not specified in terms of number of devices or "cases." The "tests" here refer to laboratory evaluations on physical devices (e.g., a certain number of oxygenator units were subjected to gas transfer, heat exchange, etc., tests). The specific number of units isn't detailed in this summary.
• Data Provenance: The tests were conducted internally by Dideco S.p.A. (Italy) as part of their submission to the FDA. The data is prospective in the sense that the tests were specifically performed for this submission.

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

• Not Applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic interpretations. For this device, "ground truth" refers to established physical and chemical measurement standards (e.g., for gas exchange, blood compatibility), which are measured by laboratory technicians according to specified protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in diagnostic tasks. This device is evaluated by objective physical and chemical tests against predefined specifications.

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 is not an AI-assisted diagnostic device.

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

• Not Applicable. This is a hardware medical device, not an algorithm. Performance is inherent to the device's physical function.

7. The type of ground truth used

• Physical and Chemical Measurement Standards / Predicate Device Performance: The "ground truth" is based on established engineering and biocompatibility standards (e.g., ISO 10993, ISO 7199, FDA guidance) and the performance characteristics of the legally marketed predicate devices (D 903 AVANT, D 901 Lilliput Ph.I.S.I.O., Monolyth Mimesys). The device is considered "substantially equivalent" if it meets the same functional performance levels.

8. The sample size for the training set

• Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, but not "trained" with data.

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

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

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