(87 days)
The SE Infusion System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The SE Infusion System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The addition of the Medication Management System (MMS) to the SE Infusion System will allow wireless bi-directional communication with the Alaris Server and external devices. MMS is the combination of RF communication from the SE Infusion System to/from the Alaris Server and the Alaris Proprietary software called the Inter-Server Interface Protocol (ISIP). The ISIP allows for communication between the SE Infusion System, the Alaris Server, and external devices.
The SE Infusion System with MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and verification of infusion or monitoring parameters using MMS is performed by trained healthcare professionals prior to administration of medication(s).
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Cardinal Health, Alaris Products SE Infusion System with MMS. It primarily focuses on the device description, its intended use, and its substantial equivalence to a predicate device. The "Performance Data" section states broadly that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," but it does not provide any quantitative data, study design, or specific acceptance criteria.
Therefore, I cannot fulfill most of your request from the given information. Below is a response based on what can be extracted and a clear indication of what information is missing.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not quantified in the provided text. The document only states that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device."
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 for Test Set: Not specified.
- Data Provenance: Not specified.
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 as no specific test set and ground truth establishment is described in the provided text. The document mentions "trained healthcare professionals" for data entry and validation, but this pertains to the device's intended use in clinical practice, not a study's ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set and adjudication method is described.
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. The device is an infusion pump system with a Medication Management System (MMS) for automating programming parameters, not an AI diagnostic tool involving human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a standalone study in the context of an algorithm's performance. The device's primary function is to automate programming parameters, and it is intended for use by "trained healthcare professionals." The functionality of the MMS relies on communication and software, which could be considered algorithmic, but its performance is always in conjunction with a user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no specific ground truth for a study is described. The device's functionality is about accurately processing and delivering infusion parameters according to orders, validated by healthcare professionals.
8. The sample size for the training set
- Not applicable as no machine learning model or training set is described.
9. How the ground truth for the training set was established
- Not applicable as no machine learning model or training set is described.
Summary of what is available from the text:
The provided text describes the Cardinal Health, Alaris Products SE Infusion System with MMS as a device intended to automate the programming of infusion parameters, thereby reducing manual steps. It communicates wirelessly with an Alaris Server using proprietary software. The document asserts that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," which is the Medley System with MMS (K030459). However, no specific performance data, acceptance criteria, or study details are provided to support this claim in the given excerpts. The review by the FDA (K043590) confirms substantial equivalence, allowing the device to be marketed.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).