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The Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

This document describes a 510(k) premarket notification for a medical device called the "Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator". This is a regulatory submission for a device, not a study of an AI algorithm, therefore the requested information fields related to AI, ground truth, expert review, and sample sizes for training/test sets are not applicable.

Here's the relevant information extracted from the provided text:

Device: Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator

Indications for Use: Intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Predicate Device: Apex M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (K020997) and Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to compliance with established standards and specifications. The "reported device performance" is described in terms of meeting these specifications and being substantially equivalent to the predicate device.

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

The document refers to "in vitro testing" and "applicable tests" being carried out. It does not provide specific sample sizes (e.g., number of devices tested) for these nonclinical tests. The tests were performed on devices aged to an equivalent of three years real-time aging. The data provenance is implied to be from internal testing conducted by the manufacturer (Sorin Group Italia S.r.I. in Italy), but no explicit country of origin for the data is mentioned, nor is it specified as retrospective or prospective.

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 medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study using expert-derived ground truth.

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

Not Applicable. This is a medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study involving human adjudication of results.

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 a medical device 510(k) submission for a physical medical device (oxygenator), not an AI-assisted diagnostic or clinical decision support system. No human reader studies with or without AI assistance were performed.

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

Not Applicable. This is a medical device 510(k) submission for a physical medical device (oxygenator), not a standalone AI algorithm.

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

For the nonclinical and in vitro tests, the "ground truth" (or basis for evaluation) was established by recognized industry standards (ISO 10993-1:1997, ISO 7199) and FDA guidance documents (FDA May 1, 1995 Memorandum on biocompatibility, Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - November 13, 2000). The device's performance was compared against the "established specifications" derived from these standards and the performance of the legally marketed predicate device.

8. The sample size for the training set

Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires training data.

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

Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires ground truth for a training set.

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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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