(177 days)
The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
The ARKRAY Diabetes Data Management Software is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The subject device consists of a USB data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. The software does not recommend any medical treatment or medication dosage level.
The provided document describes the ARKRAY Diabetes Data Management Software (SMBG Viewer), an accessory for ARKRAY blood glucose meters. This software facilitates the transfer, historical tracking, and analysis of blood glucose results.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the software itself, beyond its functional capabilities. The summary focuses on the software's role in data management and its substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to download blood glucose results from ARKRAY meters. | Device allows user to download blood glucose results from their glucose meter to their computer. |
| Ability to maintain a history of glucose test results. | Device maintains a history of their glucose test results. |
| Ability to convert data into graphs, charts, and reports. | Device converts data into graphs, charts, and reports. |
| Ease of operation by in-home users. | Consumer studies demonstrated the systems ability to be easily operated by in-home users. |
| Functionality of USB data transfer cable. | Validation of the system's hardware (USB data transfer cable) was performed. |
| Functionality of software. | Validation of the software was performed. |
| Does not recommend medical treatment or medication dosage. | The software does not recommend any medical treatment or medication dosage level. (This is a safety/limitation statement rather than a performance metric but is crucial for its intended use). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "consumer studies that demonstrated the systems ability to be easily operated by in-home users." However, it does not specify the sample size for these consumer studies or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the device is data management software for blood glucose meters, the "ground truth" for its primary function (transferring and displaying data accurately) would likely be the data produced by the blood glucose meters themselves, and its accurate visual representation. The consumer studies likely evaluated usability rather than clinical diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for studies where expert interpretation or consensus is required (e.g., image analysis). For data management software, the "adjudication" would likely involve verifying that the software accurately displays the data it receives from the meter.
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 done or mentioned. This type of study is usually conducted for diagnostic aids where human readers interpret medical images or complex data, and the AI is designed to assist in that interpretation. This device is a data management tool, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation, in the context of diagnostic algorithms, typically refers to the algorithm's performance in isolation. For this device, the "standalone" performance would be its ability to correctly download, store, and display blood glucose data. The document states that "A full array of in-house testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems. Testing included validation of the systems hardware (USB data transfer cable) and software..." This implies that the software's functional performance (without human interaction for its core data handling tasks) was evaluated. However, specific metrics for this standalone performance aren't detailed, beyond successful validation.
7. The Type of Ground Truth Used
For the functional aspects of the software (data transfer, storage, display), the "ground truth" would be the raw data from the blood glucose meters themselves. The validation would verify that the software accurately receives, stores, and presents that exact data. For the "consumer studies," the ground truth was likely subjective user feedback regarding ease of use and satisfaction.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The ARKRAY Diabetes Data Management Software is described as a data management tool, not a machine learning or AI algorithm that requires a training set. Its functionality is based on programmed logic for data transfer and display.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as the device does not appear to utilize a 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.