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Provides controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutaneous, arterial and intravenous applications.

Linear Peristaltic Infusion Pump

Here's an analysis of the provided text regarding the Sabratek 4040 Infusion Pump, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the key performance characteristic highlighted and compared is the Flow Accuracy.

It's important to note that the document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting explicit acceptance criteria for a new device against a predefined benchmark. The "acceptance criteria" here are derived from the performance of the predicate devices. The Sabratek 4040 meets or exceeds the flow accuracy of both predicate devices.

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

The document states: "Non-clinical tests included accuracy testing and comparison with Sabratek's stated accuracy claim and recording of data."

• Sample Size: Not specified. The document does not provide any details regarding the number of units tested, the number of measurements taken, or specific test protocols that would allow for the determination of sample size.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is highly likely that the testing was conducted domestically (US) or by a manufacturer associated with US regulatory requirements. There is no information to indicate if the data was retrospective or prospective, but for device approval, it would typically be prospective testing specifically for the submission.

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

• Not applicable. This device is an infusion pump, and its "ground truth" for performance is established through objective engineering and metrological measurements (e.g., flow rate calibration, volume dispensed) rather than subjective expert interpretation (like a radiologist reading an image). There would be no need for medical experts to establish a "ground truth" for the device's accuracy performance.

4. Adjudication Method for the Test Set

• Not applicable. As the "ground truth" is based on objective measurements, there would be no subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not relevant for an infusion pump. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, implicitly. The "accuracy testing" mentioned is a standalone performance test of the device itself. The infusion pump operates without human intervention in its core pumping and accuracy functions. The stated performance of "+/-5%" for Flow Accuracy is a standalone performance metric of the device.

7. The Type of Ground Truth Used

• Engineering/Metrological Measurements. The ground truth for infusion pump accuracy is objective and quantifiable. It involves precisely measuring the volume of fluid dispensed over a given time and comparing it to the programmed flow rate. This would involve calibrated equipment and measurement standards.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical/electronic infusion pump, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its engineering design, calibration, and manufacturing specifications.

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

• Not applicable. As stated above, there is no training set for this device.

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