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510(k) Data Aggregation
(27 days)
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
Instrument Operating Principle -- reflectance
Reagent Test Principle -- glucose dehydrogenase
The Accu-Chek Compact Test Strip (modified) demonstrates substantial equivalence to the legally marketed predicate device (Accu-Chek Compact Test Strip, predicate) based on performance testing that met predetermined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to the predicate device and the statement that "All predetermined acceptance criteria were satisfied." While explicit numerical acceptance criteria for each metric are not provided, the following table summarizes the reported performance of the modified device across various metrics, allowing for an implicit comparison to an assumed acceptable range.
| Metric | Acceptance Criteria (Implied by Predicate Performance and "All criteria satisfied") | Reported Device Performance (Modified Accu-Chek Compact Test Strip) |
|---|---|---|
| Test time | Likely acceptable if reduced or similar to predicate (15 seconds) | 8 seconds (Improved) |
| Minimum sample volume | Likely acceptable if reduced or similar to predicate (3.5 uL) | 1.5 uL (Improved) |
| Interference from triglycerides | Likely acceptable if higher or similar to predicate (> 1000 mg/dL) | > 5000 mg/dL (Improved) |
| Bilirubin | Likely acceptable if similar to predicate (> 20 mg/dL) | None (Improved, implies no interference at any level) |
| Fluoride | Likely acceptable if clearly defined as interfering, similar to predicate | Listed as interfering preservative in specimen collection section. |
| Accuracy (N=120) | Close correlation to laboratory reference, comparable to predicate (Y=0.954x+1.8, r=0.992) | Y=0.99x-1.96, Correlation coefficient = 0.983 |
| Range (Accuracy) | Comparable to predicate (64 - 350 mg/dL) | 56 - 531 mg/dL (Wider range) |
| Consumer Studies (N=120) | Close correlation, comparable to predicate (Y=0.956x+2.0, r=0.994) | Y=1.05x-5.065, Correlation coefficient = 0.983 |
| Range (Consumer Studies) | Comparable to predicate (63 - 359 mg/dL) | 56 - 531 mg/dL (Wider range) |
| Precision, aqueous, low | SD similar to predicate (1.0) | Mean = 43.2 mg/dL, SD = 1.0 (Comparable) |
| Precision, aqueous, mid | N/A (Predicate had data, modified did not claim) | None claimed |
| Precision, aqueous, high | %CV similar to predicate (2.4) | Mean = 339 mg/dL, %CV = 1.5 (Improved) |
| Precision, blood, low | SD similar to predicate (1.4) | Mean = 36 mg/dL, SD = 1.0 (Improved) |
| Precision, blood, mid | %CV similar to predicate (1.9) | Mean = 165 mg/dL, %CV = 1.4 (Improved) |
| Precision, blood, high | %CV similar to predicate (3.0) | Mean = 300 mg/dL, %CV = 1.5 (Improved) |
2. Sample Size Used for the Test Set and Data Provenance:
- Accuracy (Professional Use): N = 120
- Consumer Studies (Lay Use): N = 120
- Precision, aqueous: N = 10 for each level (low, high)
- Precision, blood: N = 10 for each level (low, mid, high)
- Data Provenance: Not explicitly stated, but the submission is from Roche Diagnostics Corporation in Indianapolis, IN, USA. The phrase "A multi-center performance study was conducted to evaluate the accuracy and precision" suggests potential multiple locations, but specific countries or retrospective/prospective nature are not detailed. However, given the context of a 510(k) submission for a glucose meter, it is highly likely these were prospective studies conducted to evaluate the modified device.
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. The study refers to a "laboratory plasma glucose reference test methodology" but does not specify the number or qualifications of experts involved in generating this reference or reviewing the results.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
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:
This information is not applicable. The device is a glucose meter, not an AI-assisted diagnostic imaging or interpretation system requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The study primarily evaluates the performance of the Accu-Chek Compact Test Strip (modified) system, which includes the strip and meter. The accuracy and precision figures provided represent the standalone performance of this system against a laboratory reference. While a human user is involved in collecting the sample and operating the device, the data presented (Y=mx+b equations, correlation coefficients, precision values) reflect the intrinsic performance of the device itself (the "algorithm" or measurement principle).
7. The Type of Ground Truth Used:
The ground truth for the accuracy studies was established using a laboratory plasma glucose reference test methodology. This implies a highly accurate and standardized laboratory method, typically a central lab analyzer, used to determine the true glucose concentration in the blood samples.
8. The Sample Size for the Training Set:
This information is not provided in the document. Glucose meters typically do not involve AI algorithms that require "training sets" in the conventional sense of machine learning. The device's performance is based on its chemical and optical components.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a "training set" for an AI algorithm in this context. The manufacturing process and quality control of the test strips and meter would be established against internal standards and reference materials.
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