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The EOS PMP hollow fiber oxygenator is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 LPM. 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 device is intended to be used for 6 hours or less.

The EOS PMP Hollow Fiber Oxygenator (hereinafter identified as EOS PMP) consist of an oxygenator with an integrated heat exchanger.

The EOS PMP consist of the following main components

• a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surqery.
• . an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood..

The modified device is a modified version of the currently marketed EOS product.

Here's a breakdown of the acceptance criteria and study information for the EOS PMP device, based on the provided text:

Device: EOS PMP Hollow Fiber Oxygenator

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing related to the modification of the EOS PMP device (addition of an epoxy phenolic primer coating to the heat exchanger). The acceptance criteria are implicitly that the modified device performs comparably to the unmodified predicate device and meets established standards.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "in vitro testing was performed" and "This performance testing was conducted on sterile aged devices." It does not provide a specific number of units tested.
• Data Provenance: The studies were retrospective in the sense that they evaluated a modified version of an existing device (EOS PMP) against its unmodified predicate. The testing itself (heat exchanger performance, mechanical integrity, flaking/leaching) appears to be laboratory-based and controlled, thus prospective in execution within that controlled environment. The country of origin of the data is not specified beyond "Sorin Group Italia S.R.L." which suggests it was likely performed in Italy or by a contracted lab.

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

• This question is not applicable as the evaluation was based on non-clinical (in vitro) performance data against established standards and a predicate device, rather than on expert interpretation of patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as the evaluation did not involve human interpretation or adjudication of results in the traditional sense; it was based on meeting pre-defined physical and chemical performance metrics.

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

• No, an MRMC comparative effectiveness study was not done. This device is a medical device (oxygenator), not an AI diagnostic tool. The document states: "No clinical testing was conducted in support of the EOS PMP, as the indications for use are equivalent to those of the predicate, which have been on the market for many years."

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth used was based on established industry standards and regulatory guidance (ISO 10993-1, FDA Guidance for Cardiopulmonary Bypass Oxygenators, ISO 7199), and the performance of the legally marketed predicate device (Unmodified EOS PMP). The goal was to prove "substantial equivalence" of the modified device to the predicate for specific performance characteristics.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the AI/ML context.

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

• This question is not applicable for the same reason as #8.

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EOS PMP Integrated: Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir
The device is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. 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 (gravity or vacum assisted) during nomal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.

EOS PMP: Hollow Fiber Oxygenator
The device is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. 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 device is intended to be used for 6 hours or less.

The EOS PMP is a high efficiency hollow fiber diffusion membrane oxygenator with integrated heat exchanger.
The device provides oxygenation and carbon dioxide removal from patient's blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia, or aids in the maintenance of normothermia during surgery.
The device can be operated at flow rates up to 5 liters per minute (I/min).
The device can be connected with, but not limited to, the D905 EOS reservoir (K043323) that collects, defoams, and filters patient's blood.
The EOS PMP is a modified version of the currently marketed D905 EOS (K043323).

The provided text describes a 510(k) premarket notification for a medical device, the EOS PMP and EOS PMP Integrated, which are hollow fiber oxygenators. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (D905 EOS).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Summary of Device Performance and Acceptance Criteria:

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document states that "In vitro testing was conducted on the oxygenating module that is the only device element subject to modifications with respect to the unmodified device." However, it does not specify the sample size (e.g., number of devices tested) for these in vitro tests.
   • Data provenance: The tests were "in vitro," meaning they were conducted in a controlled, non-living environment (e.g., laboratory setting), rather than with human or animal subjects. The document does not specify a country of origin for the data; the submitter is "Sorin Group Italia," suggesting the tests might have been performed in Italy or by a third-party laboratory.

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

   • This information is not provided in the document. The tests are described as "in vitro" and against "relevant requirements of 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'," suggesting objective, measurable criteria rather than expert interpretation of results.

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

   • This information is not provided as the testing involved in-vitro performance measurements against established guidances/standards, not expert adjudication of subjective findings.

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:

   • No MRMC comparative effectiveness study was done or mentioned. This device is a cardiopulmonary bypass oxygenator, not an AI-assisted diagnostic tool requiring human reader involvement.

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

   • This question is not applicable. The device is a physical medical device (an oxygenator), not an algorithm or software. The "standalone performance" was assessed through the in-vitro functional/performance tests.

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

   • The ground truth for the in-vitro performance tests was based on pre-defined acceptance criteria derived from "relevant requirements of 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'" and ISO 10993-1 for biological evaluation. These guidances and standards establish objective measurable benchmarks for safe and effective performance of such devices.

7. The sample size for the training set:

   • This information is not applicable as this is not a machine learning/AI device that requires a training set. The "modified device" (EOS PMP) was compared to an "unmodified device" (D905 EOS) and evaluated against established performance criteria.

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no training set for this type of device.

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