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The D 100 L001 Ph.I.S.I.O. Newborn-Hollow Fiber Membrane Oxygenator with Phosphorilcholine Coating is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned 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 is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation, to always assure the proper oxygenation capability of the device. The D 100 L001 Ph.I.S.I.O. should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D 100 L001 Ph.I.S.I.O Newborn Hollow Fiber Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir with phosphory/choline coating (hereafter referred to as the D 100 Ph.I.S.I.O) is a high efficiency microporous newborn hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell cardiotomy/venous reservoir. The device is a modified version of the currently marketed D 901 Ph.I.S.I.O. Newborn Hollow Fiber Membrane Oxygenator with phosphoryIcholine coating unmodified device (K991737, K010478) (hereafter referred to as the D 901 Ph.I.S.I.Q.), The modification is limited to an overall reduction in the size of the device, design change to the integrated heat exchanger and hardshell cardiotomy/venous reservoir and consequent updating of product specifications in the IFUs. The reduction in size enables the device to be better suited for surgical procedures on smaller pediatric patients (newborn) where a minimal priming volume is required. Other than this change the D 100 Ph.I.S.I.O. and the D 901 Ph.I.S.I.O. are identical in intended use, materials and manufacturing processes.

The provided text describes a 510(k) summary for the Sorin Group Italia S.r.l. D 100 L001 Ph.I.S.I.O. Newborn Hollow Fiber Oxygenator. This device is a modified version of an existing oxygenator (D 901 Ph.I.S.I.O.) with changes primarily focused on reduced size and design alterations to the heat exchanger and reservoir, intended for use in smaller pediatric patients (newborns).

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly list a table of quantifiable acceptance criteria with corresponding performance metrics for the D 100 Ph.I.S.I.O. The studies conducted were primarily comparative, aiming to demonstrate substantial equivalence to the predicate device (D 901 Ph.I.S.I.O.) rather than meeting discrete, pre-defined numerical thresholds for a novel device.

However, the text implies that the acceptance criteria are met if the device's performance is either "substantially equivalent" to the predicate, or if observed differences are explainable by the design changes and still suitable for the intended use. The "results of these tests met established specifications" is a recurring phrase, indicating that internal specifications were indeed met, although these are not detailed in the provided summary.

General implied performance areas and their qualitative results:

Study Details

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

   • The document describes in vitro testing. There is no mention of a "test set" in the context of clinical trials or patient data. Instead, the "test set" refers to the devices themselves that were subjected to various in vitro performance assessments.
   • The sample size for these in vitro tests (e.g., number of devices tested for gas transfer, pressure drop, etc.) is not specified.
   • Data provenance: All testing described is in vitro (laboratory-based) and "carried out in accordance with the requirements of 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions – Final Guidance for Industry and FDA Staff' ... and ... ISO 7199 (1996)." This implies the studies were conducted by the manufacturer, Sorin Group Italia S.r.l., likely in Italy.

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

   • This question is not applicable to this type of submission. The studies described are in vitro performance tests of a medical device, not evaluations of human-interpretable data (like medical images) where expert ground truth is typically established. The "ground truth" for these tests would be the physical/chemical properties and functional performance of the device as measured by standardized laboratory methods.

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

   • This question is not applicable. Adjudication methods are relevant for resolving discrepancies among multiple human readers/reviewers of data (e.g., medical images). The studies here are objective laboratory measurements.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD devices where human interpretation is involved. The device here is a physical medical device (oxygenator) used in cardiopulmonary bypass.

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

   • This is not applicable. This is a physical medical device, not an algorithm or AI. The tests performed are "standalone" in the sense that they assess the device's technical performance directly, independent of a human operator's skill in interpreting outputs, beyond standard laboratory procedures.

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

   • The "ground truth" for the in vitro tests is derived from objective laboratory measurements performed according to established international and FDA guidance documents (e.g., ISO 7199, FDA Guidance for Oxygenators). The "truth" is whether the device's measured performance parameters fall within pre-defined specifications or are comparable to the predicate device's performance. For biocompatibility, the ground truth relates to the absence of toxic effects as per ISO 10993.

7. The sample size for the training set:

   • This question is not applicable. This device is a physical medical device. It does not involve a "training set" in the context of machine learning.

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

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

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