(31 days)
The Ascensia ""Glucofacts and the Ascensia WinGlucofacts Professional software are accessories to the AscensiaTM Blood Glucose monitoring systems. The Ascensia ""Glucofacts and the Ascensia """Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.
The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software consist of a CD, and a connecting cable. It is to be used with a compatible blood glucose meter and a Personal Computer (PC). The software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.
The provided text is a 510(k) Summary for the Ascensia™ WinGlucofacts® and WinGlucofacts® Professional software. It details the device, its intended use, and states that performance studies were conducted. However, it does not provide detailed acceptance criteria or numerical performance data.
Based on the provided text, here is what can and cannot be extracted regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states that "Internal and external Performance/Validation studies were conducted." and that these "demonstrate satisfactory performance." However, specific quantitative or qualitative acceptance criteria are not mentioned, nor are the actual performance metrics achieved. | Not explicitly quantified or detailed. The document broadly claims "satisfactory performance" and that the devices are "equivalent in performance to the predicate devices." No numerical results, such as accuracy, precision, or reliability metrics, are provided. |
Summary: The document claims "satisfactory performance" and "equivalence" to a predicate device but does not specify the criteria or provide concrete performance data.
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. The document only mentions "Internal and external Performance/Validation studies were conducted." It does not provide details on the source, nature (retrospective/prospective), or location (country) of the data used in these studies.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Summary: This information is not mentioned in the provided text. The device is software for managing blood glucose results, which would typically involve comparing software outputs to known blood glucose values from meters or laboratory tests. The concept of "experts establishing ground truth" in the diagnostic imaging sense might not directly apply here, but rather a validation against instrument readings or laboratory standards. However, the document does not elaborate on the process or personnel involved in this validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
Summary: This information is not mentioned in the provided text.
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
- MRMC Study Done: Not applicable/Not specified. This device is data management software for blood glucose results, which primarily facilitates review by individuals or healthcare professionals. It is not an AI-assisted diagnostic tool in the sense of imaging analysis where human readers "improve" with AI assistance. The software provides data management and statistical/graphical tools, rather than directly interpreting data in a way that would lead to a comparative effectiveness study of human reader improvement with/without AI assistance.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study Done: Yes, implicitly. The "Performance Data" section states that "Internal and external Performance/Validation studies were conducted." While not explicitly called "standalone," the validation of software performance typically involves testing its functionality, accuracy of calculations, and data display capabilities independently of a human's ultimate interpretation beyond basic user interaction. The objective is to demonstrate that the software itself functions correctly and accurately processes the blood glucose data.
Summary: The document implies that the software's performance was validated without explicit human interpretative involvement beyond its intended use as a data management tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified directly. For blood glucose data management software, the "ground truth" would generally be the actual blood glucose values as read by the compatible blood glucose meter or, in a more rigorous validation, potentially values confirmed by a laboratory reference method. The document refers to "capturing blood glucose meter results," implying the meter readings themselves (or a validated source of those readings) serve as the reference for the software's accuracy in data handling and display.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device is described as data management software that uses "standard statistical and graphical tools/techniques." It does not appear to be an AI/machine learning model that requires a "training set" in the conventional sense. Its functionality is based on established algorithms for data storage, calculation, and visualization, rather than learning from data.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. As noted above, a "training set" and associated ground truth establishment for such a set are not relevant for this type of software as described.
§ 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.