(36 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 TheraSense FreeStyle Blood Glucose System.
The SMS Glucose Control consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions 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 provided text describes the SMS Glucose Control device, a quality control material for blood glucose monitoring systems. However, the document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance data in the format requested.
Therefore, much of the requested information, particularly quantitative results, sample sizes for test/training sets, expert qualifications, and specific study designs like MRMC or standalone performance, is not available in the provided text.
Based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it lists performance characteristics that were verified and concludes that the comparison of these characteristics "support the claim of substantial equivalence." This implies that the performance of the SMS Glucose Control was deemed comparable/equivalent to the predicate devices.
| Characteristic | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (as inferred from "substantial equivalence") |
|---|---|---|
| Stability | Performance equivalent to predicate devices over shelf life | Testing suggests equivalent stability |
| Open Vial | Performance equivalent to predicate devices after uncapping | Testing suggests equivalent open vial stability |
| Microbial Stress Stability | Performance equivalent to predicate devices under microbial challenge | Testing suggests equivalent microbial stress stability |
| Test Precision | Precision equivalent to predicate devices when used with the target blood glucose monitor | Testing suggests equivalent precision |
| Formulation | Identical or substantially similar to predicate devices (specifically Predicate Device No. 2 for matrix) | Identical to Predicate Device No. 2 (Buffered aqueous solution of D-Glucose, viscosity modifier, preservatives, and other non-reactive ingredients) |
| Intended Use | Same as predicate devices (for performance assessment of TheraSense FreeStyle Blood Glucose Monitor by professionals and home users) | Identical to predicate devices |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only states that "Tests were performed to verify specific performance characteristics." It does not mention if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable/specified. For a quality control material like this, "ground truth" would typically refer to the known concentration of glucose in the control solution itself, which is a manufacturing specification, not something established by human experts in the context of clinical interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. This device is a chemical control solution.
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
- Not applicable. This device is a quality control solution, not an AI diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical chemical control solution, not an algorithm. Its "standalone performance" would be its chemical stability and glucose concentration accuracy. The document mentions "stability," "open vial," "microbial stress stability," and "test precision" as verified characteristics, which are indicative of standalone performance for such a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a glucose control solution, the "ground truth" would be the assigned value of glucose concentration in the control solution itself, determined through validated analytical methods during manufacturing. The document states it contains a "known quantity of glucose," which implies this manufacturing-defined ground truth.
8. The Sample Size for the Training Set
- Not applicable. This is a manufactured chemical control solution, not a machine learning model requiring a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
§ 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.