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The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times.

The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced by a drop-in replacement microprocessor-EPROM daughter board and that associated memory addresses in the software are modified to accommodate the hardware change.

The exterior surfaces are made of plastics. There are no fluid or drug contacting surfaces.

This document is a 510(k) summary for the Medex Medfusion 2001, 2010, & 2010i syringe pumps with a new microprocessor/memory system. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance for a medical device. This type of document does not typically contain the kinds of detailed performance study data you're asking for (e.g., acceptance criteria, test set sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The purpose of a 510(k) submission, especially for a device modification like this where only the microprocessor/memory system is changed, is to demonstrate substantial equivalence to a predicate device that is already legally marketed. This usually involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.

Based on the provided text, here's what can be inferred or stated about your questions:

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

   • Not provided in the document. The document states, "The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced... They are identical in operation, function, features, and form as their predicate devices and represent no technological differences." This implies that the acceptance criteria and performance expected for this modified device would be the same as the predicate devices, but these specific criteria or performance metrics are not detailed here.

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

   • Not provided in the document. Since the change is internal (microprocessor/memory), any testing would likely focus on verifying the functionality of the new chip and its integration, rather than extensive clinical efficacy studies typically associated with new device types.

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/Not provided. For a syringe pump, 'ground truth' in the context of expert diagnosis or interpretation isn't relevant. Verification would be against engineering specifications and functional testing.

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

   • Not applicable/Not provided. This method is used for resolving discrepancies in expert interpretations, which is not relevant for this device type or the nature of the change.

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 device is a syringe pump, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This device is a physical medical device (syringe pump) not an algorithm. Performance validation would involve engineering tests, not standalone algorithm performance.

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

   • Likely engineering specifications and functional performance metrics. For a syringe pump, 'ground truth' would refer to whether the pump accurately delivers fluids at the programmed rates and volumes, within specified tolerances, and whether the new microprocessor/memory system performs as intended without errors. This would be verified through calibration and performance testing against established engineering benchmarks.

8. The sample size for the training set:

   • Not applicable/Not provided. As this is a hardware modification to an existing device, and not an AI/machine learning product, there is no "training set" in the sense of data used to train an algorithm.

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

   • Not applicable. See point 8.

In summary: The provided 510(k) summary is for a minor technical modification to an existing device (changing a microprocessor/memory chip). It focuses on demonstrating equivalence to predicate devices rather than detailing extensive clinical study results or AI performance metrics. Therefore, most of the specific questions about acceptance criteria, detailed study design, and ground truth establishment (as typically applied to diagnostic algorithms) are not addressed in this type of document.

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