(73 days)
The Animas ezManager® MAX Diabetes Management Software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.
The provided text describes the Animas ezManager® MAX Diabetes Management Software, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment.
Here's a breakdown of what is and is not available in the provided text, in relation to your request:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states the device "met software verification and validation test parameters, and label comprehension study requirements" but does not specify what those parameters or requirements were, nor the numerical performance results against them.
- Sample size used for the test set and the data provenance: No details are provided about the size of the test set for verification/validation, nor the origin of any data used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for testing.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "software verification and validation test parameters" would likely involve standalone testing, but no details are provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- The sample size for the training set: As this is software that processes existing data, there isn't a "training set" in the machine learning sense. The software processes data from insulin pumps and blood glucose meters.
- How the ground truth for the training set was established: Not applicable in the machine learning sense for this device. The "ground truth" for this device is the accurate representation and calculation of the data it receives from the connected medical devices.
Information that is available (or can be inferred from) the provided text:
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1. Acceptance Criteria (Indirectly discussed via testing):
- Acceptance Criteria (Implied): The Animas ezManager MAX must meet "software verification and validation test parameters" and "label comprehension study requirements."
- Reported Device Performance: "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." (No specific metrics or quantitative results are provided).
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6. If a standalone was done: Yes, non-clinical testing including "software verification and validation test parameters" was performed, which implies standalone performance evaluation of the software itself. The letter states, "The Animas ezManager MAX met software verification and validation test parameters, and label comprehension study requirements to assure the device performs as intended."
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7. The type of ground truth used: For a device like this, which processes and displays data from other medical devices, the "ground truth" implicitly refers to the accuracy and integrity of the data received from the Animas insulin pumps and specified commercially available blood glucose meters, and the correctness of the software's processing, analysis, and display of that data. The software's function is to accurately reflect external data.
Summary based on the provided text:
The document states that the Animas ezManager MAX Diabetes Management Software underwent "software verification and validation test parameters, and label comprehension study requirements" and that "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." However, it does not provide detailed acceptance criteria, specific performance metrics, sample sizes, or specifics on how ground truth was established beyond the general statement of validation. It is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the way one might expect for a novel therapeutic or diagnostic device requiring extensive efficacy studies.
§ 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).