(10 days)
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, AG-6081 Single Blood Glucose Monitoring System and AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System and AG-6951 Multi Blood Glucose Monitoring System. When used with the above Blood Glucose Monitoring Systems, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Here's an analysis of the provided text regarding the Andon Health Care Management System Software's acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics beyond functional descriptions. The "Performance specifications, including any testing" section lists functionalities rather than measurable criteria with associated performance targets.
| Acceptance Criteria (Inferred from "Performance specifications") | Reported Device Performance |
|---|---|
| Read memories in meter. | Implied: Functionality available |
| Delete all memories in meter. | Implied: Functionality available |
| Set time to meter. | Implied: Functionality available |
| Draw table and graph. | Implied: Functionality available |
| Print. | Implied: Functionality available |
| Set the personal information. | Implied: Functionality available |
| Auto-detect COM port. | Yes |
| Meter Compatibility: AG-608 Series, AG-6081 Series, AG-6951 Series | Demonstrated compatibility with listed meters. |
| Installation method: Exe file | Exe file |
| Language capabilities: English, Spanish | English, Spanish |
| Types of graphs: Coordinates graph | Coordinates graph |
| System components: PC, USB cable, meter | PC, USB cable, meter |
| Software platform: Microsoft | Microsoft |
| Hardware requirements: CPU: optimal at 1,2 GHz+, Main memory: optimal at 256 MB+ RAM, Disk space: optimal 200 MB+ free space - at least 100 MB, Graphic resolution starting from 1024 x 768, CD-ROM drive, USB interface | Meets listed hardware requirements (optimal values provided) |
| Technology: Visual Basic | Visual Basic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the data provenance. It only states, "Testing of Andon Health Care Management System Software included system test and unit test."
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 provided in the document. As the device is for data management and not diagnostic interpretation, it's unlikely a ground truth established by medical experts in the traditional sense would be applicable for the software's functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any 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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is a data management software, not an AI-powered diagnostic or assistive tool for human readers. Its purpose is to transfer, store, and display blood glucose data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the software's inherent functional performance. The document states, "Testing of Andon Health Care Management System Software included system test and unit test," which implies standalone testing of the software's functions (e.g., data transfer, storage, display, printing). However, no specific details on the methodology or results of these tests are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For software like this, "ground truth" would typically refer to the expected functional behavior and data integrity. The document does not explicitly state how this ground truth was established, but it would presumably be based on software requirements and specifications (e.g., if the meter stores X data points, the software should always accurately display X data points).
8. The sample size for the training set
This information is not provided. The software described does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. It's an application for data management.
9. How the ground truth for the training set was established
Not applicable as the device is not described as an AI/machine learning model requiring a training set.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.