(54 days)
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Agamatrix WaveSense Presto Blood Glucose Monitor.
The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. It is packaged in a plastic dropper tipped bottle for easy application of the control solution to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
The AbT Glucose Control Solution is a control material for blood glucose monitoring systems. The provided documentation does not detail a study involving human readers or comparative effectiveness for diagnostic image analysis. Instead, it describes a device for quality control in glucose measurement. The performance studies focused on the stability and precision of the control solution itself, not on diagnostic accuracy in the way an AI-powered image analysis tool would be evaluated.
Here's an analysis based on the provided text, reformatted to address your specific questions about acceptance criteria and study details, albeit adapted for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For the AbT Glucose Control Solution, the "acceptance criteria" are defined by its target glucose range and its ability to maintain stability and precision within that range. The "reported device performance" reflects how these characteristics compare to predicate devices.
| Characteristic | Acceptance Criteria (Predicate Devices - Target Ranges) | Reported Device Performance (New Product - Target Range) |
|---|---|---|
| Glucose Target Range | WaveSense Normal Control Solution: 108 - 159 | AbT Glucose Control Solution: 95 - 145 |
| Liberty Normal Control Solution: 94 - 147 | ||
| Stability | Implied comparable stability to predicate devices | Found to be acceptable (see "Performance Studies") |
| Open Vial Stability | Implied comparable open vial stability | Found to be acceptable (see "Performance Studies") |
| Test Precision | Implied comparable precision to predicate devices | Found to be acceptable (see "Performance Studies") |
Note: The specific quantitative results for stability and precision are not provided in this summary but are indicated as having been performed and concluded to be satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance on patient data since this device is a quality control solution.
- Sample Size: Not applicable in the traditional sense of patient data. The "samples" would be aliquots of the control solution itself. The document does not provide the number of replicates or batches tested for stability and precision studies.
- Data Provenance: Not applicable in the context of patient data. The studies would have been conducted internally by American Biological Technologies, Inc. No country of origin for patient data is relevant here. The studies are prospective in nature, testing the manufactured control solution.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" for a control solution relates to its manufactured glucose concentration and its stability and precision characteristics, not diagnostic interpretations by experts. The "ground truth" would be established through analytical chemistry methods during production and quality control testing.
4. Adjudication Method
Not applicable. Adjudication methods are relevant for expert review of diagnostic cases, which is not the purpose of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a quality control solution, not a diagnostic tool intended for interpretation by human readers. Therefore, an MRMC study is not relevant.
6. Standalone Performance
Yes, in a sense. The "performance studies" (stability, open vial stability, test precision) are evaluations of the AbT Glucose Control Solution itself and its inherent characteristics. This is a form of standalone performance assessment, focusing on the quality and reliability of the control solution as a product. The results of these studies informed the claim of substantial equivalence to predicate devices.
7. Type of Ground Truth Used
The "ground truth" for the AbT Glucose Control Solution is based on analytical manufacturing specifications and laboratory testing.
- Glucose Concentration: The target range (95 - 145) is a defined analytical specification for the product.
- Stability: This is determined by monitoring the glucose concentration over time under various storage conditions.
- Precision: This is determined by repeatedly measuring the glucose concentration and analyzing the variability.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set" of data. Its "performance" is based on its physical and chemical properties as a control solution.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish in this context.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.