(27 days)
MT Alert Infusion Monitor is intended for use in any healthcare setting where gravity-flow infusions are utilized.
The MT Alert Infusion Monitor is a passive weighing device that alarms when the infusion bag is near-empty. The alarm point can be set by the user. In addition, MT Alert may also assist in monitoring fluid bolus administration. MT Alert will alarm when a prescribed bolus of fluid has been taken from the infusion bag. MT Alert provides various audio and visual alarms. MT Alert operates from common alkaline batteries and mounts on common poles and rods.
Here's the breakdown of the acceptance criteria and the study information for the MT Alert Infusion Monitor based on the provided document:
Acceptance Criteria and Device Performance
The provided document does not explicitly state quantitative acceptance criteria with specific performance metrics (e.g., accuracy percentages, alarm thresholds). Instead, the "Safety and Effectiveness in Comparison to Predicate Devices" section states: "The validation procedures performed on the system indicate that the new device is as safe and effective as the predicate devices."
The Substantial Equivalence Chart serves as an implicit set of functional acceptance criteria, demonstrating that the MT Alert Infusion Monitor meets or exceeds the capabilities of the predicate device (Smith & Nephew Dyonics LeveLert System).
| Feature / Acceptance Criteria | Reported Device Performance (MT Alert™) | Predicate Device (LeveLert) Performance |
|---|---|---|
| Used for monitoring the fluid level of an infusion bag. | Yes | Yes |
| Automatic alarm when the fluid level has reached a pre-determined weight with audio and visual alarms. | Yes | Yes |
| Adjustable near-empty alarm point. | Yes - Easily programmed by hanging the desired weight. | Yes. |
| Accommodates most typical infusion bag sizes. | Yes (up to 3 liter size) | Yes (up to 3 liter size) |
| Bolus monitoring feature. | Yes (1 liter mode only) | No. |
| Passive device, no fluid control functions. | Yes | Yes |
| Infusion Container hangar. | Yes | Yes |
| Pole Mounting. | Yes | Yes |
| Power | 2- AA batteries, typical 180 day life | Powered externally |
| Device Class. | Class II | Class II |
Study Details
The provided 510(k) summary is very limited in its description of the underlying studies that demonstrate safety and effectiveness. It primarily relies on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested details cannot be extracted directly from this document.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. It's likely that internal bench testing or validation was performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth in a clinical or expert review setting for the validation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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 an infusion monitor, not an AI-assisted diagnostic tool for "human readers." The document states it "can improve existing practice by notifying healthcare personnel of gravity infusion end-points." However, no formal MRMC study or effect size is mentioned for human improvement with the device vs. without.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device functions as a "standalone" monitor in that it operates independently to detect fluid levels and alarm. However, the term "standalone" in the context of performance studies usually refers to the performance of an algorithm without human intervention in a diagnostic sense. The device's primary function is to alert human personnel; it doesn't make diagnostic decisions. The document implies performance of the device itself was validated to ensure it functions as intended (e.g., alarming at the correct weight), but specific "standalone performance" metrics are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional aspects (e.g., alarming at a specific weight), the ground truth would likely be based on measured weight or volume (physical truth) rather than expert consensus or pathology. The document doesn't detail the specific methods for establishing ground truth during its internal validation.
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The sample size for the training set:
- Not applicable. This is a physical device with embedded logic, not a machine learning model that undergoes a "training" phase with a dataset.
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How the ground truth for the training set was established:
- Not applicable, as it's not a machine learning model.
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).