(28 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.
The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Active System (K021448):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets for accuracy (e.g., % within a certain range). Instead, the study aims to demonstrate "good correlation (r > 0.90)" between results from different Alternative Site Testing (AST) locations and finger results.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Upper Arm) | Reported Device Performance (Thigh) | Reported Device Performance (Calf) |
|---|---|---|---|---|
| Correlation (r) | > 0.90 | 0.984 | 0.983 | 0.982 |
2. Sample Size Used for the Test Set and Data Provenance
| AST Location | Sample Size (N) | Data Provenance |
|---|---|---|
| Upper Arm | 65 | Conducted at the manufacturing facility (likely US/Europe) |
| Thigh | 62 | Conducted at the manufacturing facility (likely US/Europe) |
| Calf | 64 | Conducted at the manufacturing facility (likely US/Europe) |
The data is prospective as it was generated from a study specifically conducted to demonstrate the device's performance with additional AST sites.
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 given document. The study compares AST results to "finger results," which is implicitly considered the reference measure. It doesn't mention a separate expert review process for the glucose readings themselves.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Since the study compares the device's readings from different sites to readings from a fingerstick (likely the same device's reading from a fingerstick or a laboratory reference), a traditional adjudication method for subjective medical imaging interpretation wouldn't apply here.
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. This type of study focuses on human reader performance, often in conjunction with AI. The provided study is a device performance study, not one evaluating human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The study assesses the accuracy of the Accu-Chek Active System when using blood samples from various alternative sites. It evaluates the device's performance independently, without human interpretation as a primary factor in the measured outcome. The device itself is the "algorithm" in this context (photometric measurement).
7. The Type of Ground Truth Used
The ground truth used is fingerstick blood glucose readings. The study implicitly uses finger results (from the same device or a similar, validated method) as the reference standard to which the Alternative Site Test (AST) results are compared. The phrase "AST location versus Finger" directly indicates this comparison.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is a device performance study, not specifically an AI/machine learning model where a training set distinct from a test set would typically be described. The "study" mentioned likely refers to the overall validation of the modified device rather than the training of a computational algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a separate training set or an AI/machine learning model being developed, this information is not applicable/provided in the document. The device's underlying technology (photometry and glucose dehydrogenase chemical reaction) is well-established, and its "training" would have occurred during the initial development and validation of the predicate device (K012324), not detailed here.
§ 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.