(20 days)
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 -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's an analysis of the provided information, describing the acceptance criteria and study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study for Accu-Chek Compact System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes modifications to the Accu-Chek Compact System regarding alternate site testing (AST) for self-testing capillary whole blood samples. The key performance characteristic assessed for this modification is the correlation between AST results and finger-prick results.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Correlation | r > 0.90 | r > 0.90 (between AST results and finger results under steady state conditions) |
Note: The document explicitly states that the "study demonstrated good correlation (r> 0.90) between AST results and finger results under steady state conditions." This indicates that the established acceptance criterion for correlation was r > 0.90. If the reported performance had been "r = 0.91", that would be an exact value, but "r > 0.90" is the reported outcome, matching the implicit criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of samples (participants or blood draws) used in the study. It refers to "results of a study conducted".
- Data Provenance: The study was "conducted at our manufacturing facility." This suggests the data was generated internally by Roche Diagnostics Corporation. The document does not specify the country of origin of the data beyond the manufacturing facility, nor does it explicitly state if it was retrospective or prospective. Given the context of a new 510(k) submission for a device modification, it is most likely a prospectively collected dataset for the purpose of this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to this device. The Accu-Chek Compact System is a glucose meter, and its performance is evaluated against a reference method (e.g., laboratory analyzer, or in this case, traditional finger-prick blood glucose results). "Ground truth" for glucose concentration is typically established by highly accurate chemical analysis methods, not by expert consensus in the way a medical image might be interpreted. There is no mention of experts establishing ground truth for this study.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is not applicable to this type of device study. Adjudication is typically used when human interpretation of data (e.g., medical images) is involved, and multiple experts' opinions need to be reconciled to establish a ground truth. For a quantitative device like a glucose meter, the "ground truth" is a measured value or a reference method's measured value, which does not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists interpreting images). This study focuses on the analytical performance of a glucose meter, specifically its ability to produce consistent results from different sample collection sites compared to a traditional site. There are no "readers" in the context of this study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study specifically evaluated the "system accuracy with AST blood from calf, thigh and upper arm" relative to finger-prick results. This assesses the device's (instrument and test strips) analytical performance independently of human interpretation of the results for diagnostic purposes. The device itself generates the quantitative glucose value, and the study validates its accuracy against a known reference (finger-prick results for the same individual under steady state). Therefore, it focused on the algorithm's (device's) ability to correctly measure glucose from different sites.
7. The Type of Ground Truth Used
The type of ground truth used was comparison to finger-prick results under steady state conditions. While not explicitly stated as a "true reference method" (like a lab analyzer), the study design implies that finger-prick results were considered the established standard for comparison, from which the AST results were not expected to deviate significantly. The aim was to show that "system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm," suggesting that the existing accuracy relative to finger-prick (and likely a lab reference) was maintained.
8. The Sample Size for the Training Set
The document does not provide any information about a specific "training set" or its sample size. This is common for this type of device submission. Glucose meters are typically developed and validated using well-established chemical principles and analytical performance studies. While there's an underlying process of calibrating and verifying the device's algorithms, the 510(k) submission typically focuses on the final validation study's performance, not the individual stages of internal algorithm development and "training" as might be described for AI/ML models.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, information on how its ground truth was established is not provided and is likely not applicable in the context of this 510(k) summary. The development of glucose measurement algorithms relies on chemical principles and calibration against highly accurate laboratory reference methods, rather than human-labeled ground truth datasets in the way AI models are trained.
§ 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.