(24 days)
The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and overthe-counter sale.
Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.
Instrument Operating Principle -- amperometric
Reagent Test Principle -- glucose dehydrogenase
The provided text indicates that the Accu-Chek Advantage (modified) System underwent performance testing to demonstrate its substantial equivalence to the predicate device. However, the document does not contain a table of specific acceptance criteria or detailed results of the device's performance against those criteria. It only states that "All predetermined acceptance criteria were satisfied."
Here's an analysis of the provided information related to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "All predetermined acceptance criteria were satisfied." However, the specific acceptance criteria and the detailed performance results are not listed.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "Performance testing" but does not specify the sample size used for the test set or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not available. For glucose measurement devices, the "ground truth" is typically established through reference laboratory methods (e.g., YSI analyzer) rather than expert consensus on images or clinical assessments. The document does not provide details on how ground truth was established, but it is highly unlikely to involve human experts for this type of device.
4. Adjudication Method for the Test Set
Not applicable/Not available. Since the ground truth for glucose measurement is established by laboratory methods, an adjudication method for expert consensus is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not relevant for a glucose measurement device. MRMC studies are typically used to assess the performance of diagnostic imaging aids where human readers interpret medical images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes (implicitly). The "Performance testing on the modified Accu-Chek Advantage (modified) System" implies standalone performance, as a glucose meter directly measures glucose levels and does not involve a human interpretation loop in the same way an AI for image analysis would. The device's performance is its output.
7. The Type of Ground Truth Used
Implicitly, a reference laboratory method. For glucose meters, the ground truth for "quantitatively measure the concentration of glucose" is established by comparing the device's readings to those obtained by a highly accurate and precise reference laboratory method (e.g., a YSI glucose analyzer). This is a well-established practice in the in vitro diagnostics industry, though not explicitly stated in this summary.
8. The Sample Size for the Training Set
Not applicable/Not available. This device is an electrochemical glucose meter. There is no mention of a "training set" as would be used for machine learning algorithms. The device's performance is based on its chemical and electrical design, not on a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As mentioned above, there is no "training set" in the context of this device.
Summary of what is available from the provided text:
- Acceptance Criteria & Performance: Stated that "All predetermined acceptance criteria were satisfied," but no details are provided.
- Study Type: Performance testing was conducted to demonstrate substantial equivalence to the predicate device.
- Comparison: The modified device was deemed "substantially equivalent" to the current legally marketed Accu-Chek Advantage System.
- Intended Use: Quantitatively measure the concentration of glucose in capillary whole blood.
- Measuring Principle: Amperometric, using glucose dehydrogenase.
§ 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.