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The Disetronic Multifuse Pump with its accessories is intended for the controlled delivery of parenteral fluids, including patient controlled analgesia (PCA), in both the hospital and home care environments.

The Disetronic Multifuse pump is a small, battery-operated peristaltic infusion pump that is suited for ambulatory hospital and home use. The pump is extremely versatile. It has been designed to allow the health provider program the pump to provide one of several types of infusion therapies. The pump can be configured as a continuous rate infusion pump with demand bolus capability, a variable rate infusion pump with demand bolus capability, a Patient Controlled Analgesia (PCA) pump, a Total Parenteral Nutrition (TPN) pump or an intermittent infusion pump. The health provider can further customize the pump for a specific patient by allowing or excluding optional programming steps, limiting allowable ranges, adjusting the rate at which boluses are infused and adjusting alarm and display features. These control functions can only be performed by using the Multifuse Computer Software. This proprietary control software runs on IBM compatible personal computers in the Windows® environment and communicates with the pump through an optical interface. The pump can be re-programmed as required for different patients. This versatility enables the health care provider minimize the different types of pumps and still provide for almost all infusion therapies.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disetronic Multifuse Pump System.

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to currently marketed devices rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed study results as one might expect for a novel AI device. Therefore, much of the requested information, particularly around AI-specific testing, ground truth, and expert involvement, is not applicable or not present in this document.

Summary of Device Acceptance Criteria and Performance (Based on provided text):

The document doesn't explicitly list "acceptance criteria" in the format typically seen for AI device performance. Instead, it refers to regulatory and engineering standards. The reported device performance is primarily described through its functional equivalence to predicate devices and adherence to relevant standards.

Detailed Information as Requested (with explanations for missing data):

1. A table of acceptance criteria and the reported device performance:
   (Refer to the table above).

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

   • Sample Size (Test Set): Not specified. The document describes compliance with standards and functional testing, but does not provide details on the number of devices or test conditions used for "testing." This is typical for a 510(k) where the focus is on engineering and safety validation, not large-scale clinical trials with "test sets" in the AI sense.
   • Data Provenance: Not applicable. The testing appears to be primarily engineering verification and validation, not data-driven performance evaluation from patient data.

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 specified. The concept of "ground truth" established by human experts is not relevant to this type of device submission. The "ground truth" for a medical device like an infusion pump is its adherence to its specifications, safety standards, and functional requirements, which are typically verified through engineering tests, not expert consensus on diagnoses or interpretations.

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

   • None / Not applicable. Adjudication methods are typically used in clinical studies where human interpretation of medical data is involved. This device's testing relates to its physical and software functionality.

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. This is not an AI-assisted diagnostic or interpretive device. It is an infusion pump. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.

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

   • Implied, but not detailed as "algorithm only" in the AI sense. The pump operates autonomously based on its programming. The software was tested independently to ensure it met specifications and functional requirements ("All test results demonstrate that the system specifications and functional requirements were met."). This isn't a "standalone AI algorithm" test, but rather a standard V&V for embedded software.

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

   • Engineering Specifications and Regulatory Standards. For this type of device, the "ground truth" against which performance is measured consists of:
     • The device's own design specifications (e.g., flow rate accuracy, alarm thresholds, battery life).
     • Industry and international safety standards (e.g., IEC 601-2-24, IEC 601-1, ISO 10993-1).
     • Functional equivalence to predicate devices.
   • There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of approving the pump's core functionality.

8. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI that requires a "training set" of data.

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

   • Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.

Conclusion regarding the Disetronic Multifuse Pump 510(k) Summary:

This 510(k) submission for the Disetronic Multifuse Pump System focuses on demonstrating substantial equivalence to existing legally marketed infusion pumps. The "acceptance criteria" are primarily implicit in the adherence to established international safety and performance standards (IEC 601-2-24, IEC 601-1) and the device's functional similarity to predicate devices. The "study" mentioned is the verification and validation (V&V) testing against these standards and specifications, which is typical for a medical device of this nature but does not involve AI-specific concepts like training sets, test sets derived from patient data, expert ground truthing, or MRMC studies. The document confirms that "All test results demonstrate that the system specifications and functional requirements were met," indicating successful completion of the V&V activities.

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