(26 days)
The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.
Here's a summary of the acceptance criteria and study information for the Accu-Chek Integra System, based on the provided text:
Acceptance Criteria and Device Performance
The provided text states that "All predetermined acceptance criteria were satisfied" and that the "clinical data demonstrates that the performance of the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method." However, specific numerical acceptance criteria were not detailed in the provided document. The document primarily focuses on similarities to a predicate device and general performance claims rather than specific quantitative thresholds for accuracy or precision.
The only quantitative performance mentioned that resembles an "acceptance criteria" is for Quality Control (QC) materials:
| Feature/Claim | Acceptance Criteria (from QC) | Reported Device Performance |
|---|---|---|
| Quality control acceptable range | The mean is strip lot specific and will be determined individually. The range of the controls is within ± 15 mg/dL or ± 15% compared to the determined mean. | Not explicitly stated for overall device performance, but the study "demonstrated that the device meets the performance requirements for its intended use" and "correlates well with the laboratory plasma glucose reference test method." |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "A multi-center performance study was conducted."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth is referred to as "the laboratory plasma glucose reference test method," implying a standardized lab method, but details on who performed or verified this ground truth for the test set are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This type of adjudication is typically for image-based diagnostic studies and is not directly relevant to a glucose meter study. The reference method itself acts as the gold standard.
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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. This is a glucose meter, not an AI-assisted diagnostic imaging device, so an MRMC study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Accu-Chek Integra System" performance was evaluated against a reference method. The device itself performs the measurement, and the study assesses this direct measurement capability.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Laboratory plasma glucose reference test method." This indicates a standard, probably highly accurate, clinical laboratory method for measuring glucose.
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The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in that sense. The device's calibration and performance are based on its hardware and chemical reagents.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
§ 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.