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The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the set infusion rate setting controlled through the IV administration set.

The DripAssist Plus device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. DripAssist Plus is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a compatible single-use intravascular administration set that is inserted into a mechanical attachment mechanism on the DripAssist Plus. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates a fixed percentage from the "set point." The device can be used with compatible drip sets of 10, 15, 20, or 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.

The provided document describes the DripAssist Plus, a device intended to be a supplementary monitor for gravity infusions, and its substantial equivalence to the predicate device, DripAssist (K150687). The document primarily focuses on demonstrating that the DripAssist Plus meets its specifications and is substantially equivalent to the predicate device.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a "table of acceptance criteria" with specific pass/fail thresholds for each test, nor does it present the "reported device performance" in a granular, quantitative manner for all parameters. Instead, it describes general performance characteristics and states that "Predefined acceptance criteria were met" and "results were acceptable for all testing."

However, we can infer some performance characteristics and the device's claimed adherence to them:

Inferred Acceptance Criteria and Reported Performance for DripAssist Plus (compared to DripAssist Predicate)

The document repeatedly states, "Predefined acceptance criteria were met" and "results were acceptable for all testing." This is a high-level confirmation that the device passed its internal validation studies but lacks the specific quantitative data that a typical medical device study report would provide for each specified criterion (e.g., "The accuracy was measured to be 0.8%, meeting the acceptance criterion of <=1%").

2. Sample size used for the test set and the data provenance

The document states "bench tested to verify drip rate flow measurements are accurate and the alarm functions as intended. DripAssist Plus repeated all those tests; results were acceptable for all testing."

• Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests run, duration of tests) used for any of the non-clinical tests. This information is critical for assessing the statistical power and reliability of the test results.
• Data Provenance: The testing appears to be entirely prospective bench testing conducted by the manufacturer, Shift Labs, Inc. There is no indication of patient data being used (as this is a monitoring device, not a diagnostic one that processes patient data/images). The location of the testing is not explicitly stated, but given the company's address in Seattle, Washington, USA, it is likely that the testing was conducted domestically within the USA.

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

Not applicable. This device is a flow rate monitor, not a diagnostic imaging device requiring expert interpretation of medical data (like a radiologist reading an X-ray). The "ground truth" for its performance (e.g., exact flow rate, alarm thresholds) would be established by engineered specifications and precise measurement instruments, not by human experts interpreting clinical data.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. Ground truth is established by physical measurement against engineering standards, not through human consensus or adjudication.

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 not an AI-assisted diagnostic tool that aids human readers. It is a standalone monitoring device.

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

Yes, in essence, all the non-clinical testing described (e.g., accuracy, alarm functionality, mechanical durability, EMC/EMI) represents standalone performance testing of the device's inherent mechanisms and algorithms, without a human operator's variable input being the primary focus of the test itself (though a human activates and observes the device during testing). The accuracy of the drip rate measurement (1%) and the alarm trigger accuracy (Set Rate +/- 13%) are examples of standalone algorithm performance.

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

The ground truth used for these tests would be:

• Physical Measurements/Engineering Standards: For flow rate accuracy, this would involve precise measurement of fluid volume over time using highly accurate pumps or calibrated measurement systems.
• Predefined Specifications: For alarm thresholds, mechanical durability (e.g., insertion force, drop test impacts), and electrical characteristics, the device's performance would be compared against predefined engineering specifications.
• International Standards: Compliance with standards like IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC/EMI) serves as a form of "ground truth" for safety and essential performance.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on sensors and deterministic algorithms, not learned patterns from data.

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

Not applicable, as there is no "training set" for this type of device.

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The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to ml/hr measurement and total volume. An alarm is available to alert the drip rate deviates from the infusion rate setting controlled through the IV administration set.

The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the "set point."

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

Acceptance Criteria and Device Performance

Study Information

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

   • The provided text does not specify the exact sample size for each performance test (Drip Rate Accuracy, Alarm Accuracy, EMC, Design Verification and Validation).
   • The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). These are non-clinical performance tests conducted on the device itself, rather than clinical studies on patients.

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. Given these are performance tests of a physical device measuring flow rates, the "ground truth" would likely be established through highly calibrated measurement equipment or standard reference methods, rather than expert human interpretation.

3. Adjudication method for the test set:

   • This is not applicable as the studies described are performance tests of a physical device against predefined metrics, not human-interpreted data requiring adjudication.

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. The DripAssist is an IV flow rate monitor, not an AI-powered diagnostic device. The studies were focused on the device's accuracy and performance.

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

   • Yes, the described studies (Drip Rate Accuracy Test, Alarm Accuracy Test, EMC, Design Verification and Validation) are standalone performance tests of the device itself (algorithm and hardware combined) without human-in-the-loop performance being evaluated as a primary outcome. The device's function is to monitor and alert, it does not involve human interpretation of complex data.

6. The type of ground truth used:

   • For the Drip Rate Accuracy Test, the ground truth would typically be established by a highly accurate, calibrated flow meter or precise measurement of dispensed volume over time.
   • For the Alarm Accuracy Test, the ground truth would be the actual flow rate deviation measured by calibrated equipment.
   • For EMC, the ground truth is adherence to the specified IEC standard.
   • For Design Verification and Validation, the ground truth would be the pre-defined design specifications and user requirements.

7. The sample size for the training set:

   • This information is not applicable. The DripAssist is not an AI/machine learning device that requires a "training set" in the conventional sense for developing a predictive algorithm. It operates based on pre-programmed logic for infrared detection, calculations, and alarm triggers.

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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