(25 days)
MT Alert Infusion Monitor is intended for use in any healthcare setting where gravityflow infusions are utilized.
The Stryker L3 Hydrolert is intended to monitor irrigant levels primarily during arthroscopic procedures and to alert operating room personnel of a low irrigant fluid level condition. It will offer both increased efficiency in arthroscopic procedures and universal compatibility with both arthroscopic pump and gravity fluid management systems. It is intended for use with saline solution or any other standard irrigant. It is not intended for use as an intravenous infusion monitor. The alarm is designed to be reusable.
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.
The provided document describes a 510(k) summary for the MT Alert Infusion Monitor (later referenced as Stryker L3 Hydrolert, though the initial summary is for MT Alert). This device is a passive weighing device that alarms when an infusion bag is near-empty.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but rather focuses on demonstrating "substantial equivalence" to a predicate device, the Smith & Nephew Dyonics LeveLert System. The performance is assessed by comparing the features and functions of the MT Alert with the predicate device.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (MT Alert™) |
|---|---|---|
| Used for monitoring fluid level of an infusion bag. | Yes | Yes |
| Automatic alarm when fluid level reaches pre-determined weight with audio and visual alarms. | Yes | Yes |
| Adjustable near-empty alarm point. | Yes | Yes - Easily programmed by hanging the desired weight. |
| Accommodates most typical infusion bag sizes. | Yes (up to 3 liter size) | Yes (up to 3 liter size) |
| Bolus monitoring feature. | No (for LeveLert) | Yes (1 liter mode only) - This is an enhancement over the predicate |
| Passive device, no fluid control functions. | Yes | Yes |
| Infusion container hanger. | Yes | Yes |
| Pole mounting. | Yes | Yes |
| Power. | External (LeveLert) | 2- AA batteries, typical 180 day life - Difference from predicate |
| Device Class. | Class II | Class II |
2. Sample size used for the test set and the data provenance.
The document does not provide any information about a "test set" in the traditional sense of a clinical or performance study with a specific sample size. The validation procedures mentioned are described as indicating the new device is "as safe and effective as the predicate devices," but no details on these procedures or the data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
This information is not provided in the document. The substantial equivalence argument relies on feature comparison, not independent expert assessment of device performance against a ground truth.
4. Adjudication method for the test set.
This information is not provided. As there is no described "test set" or independent expert review, there is no mention of an adjudication method.
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.
This information is not applicable and not provided. The device is a monitor for gravity-flow infusions, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
This information is not provided. Given the nature of the device as a physical monitor, the concept of "algorithm only" performance without human interaction doesn't directly apply in the way it would for, say, an image analysis algorithm. The function of the device is to alarm, and that alarm is inherently for human notification. No standalone performance data is presented beyond the comparison table.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The document does not describe the use of a ground truth in the context of a performance study. The ground truth for this submission appears to be the established functionality and performance of the legally marketed predicate device.
8. The sample size for the training set.
This information is not provided. Given that this is a physical monitoring device and not an AI/machine learning product, the concept of a "training set" is not applicable in the usual sense.
9. How the ground truth for the training set was established.
This information is not provided and not applicable for the reasons stated above.
§ 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).