(15 days)
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
The provided text describes the Accu-Chek Active System and its substantial equivalence to a predicate device, focusing on features and intended use. However, it does not contain detailed information regarding the specific acceptance criteria, a comprehensive study report, sample sizes, expert qualifications, or ground truth establishment methods in the depth requested. The document is primarily a 510(k) summary and an FDA clearance letter.
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All predetermined acceptance criteria were satisfied" but does not provide specific numerical acceptance criteria nor detailed reported device performance values. It only generally states that "The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (General Statement) |
|---|---|
| (Specific numerical criteria for accuracy, precision, etc., are not provided.) | "All predetermined acceptance criteria were satisfied." |
| "The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: A "multi-center performance study" was conducted. The country of origin is not explicitly stated. It is a prospective study, as it was conducted to "evaluate the accuracy and precision of the modified device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided text.
4. Adjudication method for the test set
Not specified 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: Not applicable. This device is a glucose meter, an automated system, not an AI-assisted diagnostic imaging or interpretation system requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
- Effect size of human reader improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a "multi-center performance study" was conducted to evaluate the accuracy and precision of the device itself, which operates as an algorithm-only system without human-in-the-loop performance for glucose measurement. The device's performance was compared to "the laboratory plasma glucose reference test method."
7. The type of ground truth used
The ground truth was established by a "laboratory plasma glucose reference test method." This implies comparison to a validated and accurate laboratory-based glucose measurement method.
8. The sample size for the training set
Not specified in the provided text. (For this type of device, what might be referred to as "training" would be part of the R&D and calibration process, not distinct in the same way as an AI model's training set).
9. How the ground truth for the training set was established
Not specified in the provided text. (As above, this information is not typically presented for a glucose meter in this format).
§ 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.