(198 days)
Plum 360™ Infusion System with Hospira Mednet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood products.
The Plum 360TM Infusion System with Hospira MedNet™ remains a volumentric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient.
The device has a user interface consisting of LCD display, front panel numeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library, and software that provides pre-defined display screens for therapy programming.
The continued use of the Hospira MedNet™ Software allows communication between the Infusion Pump, Hospira MedNet™ server and the facility's communication systems.
The provided text is a 510(k) Summary for the Plum 360™ Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical characteristics, rather than a clinical study measuring diagnostic accuracy or human reader performance with AI. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth in the context of device performance metrics (like sensitivity, specificity, accuracy) is not directly available or applicable from this document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported numerical device performance beyond stating "PASS" for various tests. The acceptance criteria for each test were meeting the requirements of the specified standard/guidance.
| Characteristics | Standard/Test/FDA Guidance | Reported Device Performance |
|---|---|---|
| Electrical and Mechanical Safety | ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, 2005 / (R)2012 / C1:2009 / (R)2012, including Amendment 1:2012 | PASS |
| Electromagnetic Compatibility | IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007-03 | PASS |
| Alarms System | IEC 60601-1-8 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Edition 2.0 2006-10 | PASS |
| Infusion Pump Basic Safety and Essential Performance | IEC 60601-2-24 Medical Electrical Equipment - Part-24: Particular Requirements for the Basic Safety and Essential Performance of Infusion Pump and Controllers, Edition 2.0 2012-10 | PASS |
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, Fourth edition 2009-10-15 | PASS |
The document also states: "System verification and validation activities for subject devices confirmed that the system meets and design inputs. All the testing met the acceptance criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are engineering and analytical tests (e.g., electrical, mechanical, EMC, biocompatibility) rather than tests on a "test set" of patient data as might be relevant for AI/diagnostic devices.
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)
This information is not applicable and not provided. The ground truth for these types of tests would be established by validated test equipment and established scientific principles, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation of data.
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
No MRMC comparative effectiveness study was conducted or reported. This document pertains to a medical device's safety and effectiveness (infusion system) through performance testing, not a diagnostic AI system requiring reader studies. The document notes "Human Factors studies have been conducted to validate the effectiveness of use related error mitigations" but does not provide details on their design or results beyond "demonstrating passing results."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an infusion system's performance testing described here. The "algorithm" here refers to the software controlling the infusion pump, and its performance is evaluated as part of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described consists of established engineering standards, regulatory requirements, and validated test methods (e.g., for electrical safety, EMC, alarm systems, pump performance, biocompatibility). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable and not provided. The device is not an AI/ML model that is "trained" on a dataset in the typical sense.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" in the context of this device's submission.
§ 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).