(35 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 Liberty Blood Glucose Monitoring System.
The Liberty Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. They are 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.
Here's an analysis of the provided information regarding the Liberty Control Solutions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., numerical thresholds for stability or precision). It lists the types of performance studies conducted but does not detail the pass/fail criteria used. Similarly, it does not provide detailed reported device performance in terms of specific values (e.g., actual stability ranges, precision CV%).
However, based on the general information, we can infer that the acceptance criteria would be linked to demonstrating substantial equivalence to the predicate devices. This implies that the performance (stability, precision) of the Liberty Control Solutions should be comparable to or better than that of the predicate devices.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Stability (Shelf-life) is acceptable. | Tests were performed to verify stability. |
| Open Vial Stability is acceptable. | Tests were performed to verify open vial stability. |
| Microbial Stress Stability is acceptable. | Tests were performed to verify microbial stress stability. |
| Test precision is acceptable. | Tests were performed to verify test precision. |
| Performance characteristics (formulation, intended use) support substantial equivalence to predicate devices. | Comparison of the performance characteristics, formulation, and intended use support the claim of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance studies (stability, open vial stability, microbial stress stability, test precision).
The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of data collection).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this device. The Liberty Control Solutions are quality control materials, and their performance is assessed against established analytical methods and specifications, not against expert interpretation of biological samples or images. Therefore, there is no "ground truth" in the sense of expert consensus on patient diagnoses or pathology for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which are not relevant to the evaluation of a quality control solution.
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 is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on reader performance. The Liberty Control Solutions are quality control materials for blood glucose monitoring systems and do not involve human readers in this context.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The device is a chemical control solution, not an AI algorithm. Its performance is inherent to its chemical composition and manufacturing, assessed through laboratory tests.
7. The Type of Ground Truth Used
For quality control materials like the Liberty Control Solutions, the "ground truth" for performance studies would be:
- Reference Method/Standard Measurements: For glucose concentration, the accurate measurement of glucose using a highly precise and validated reference method (e.g., hexokinase-based methods) would serve as the ground truth.
- Established Specifications: Manufacturers define specifications for stability (e.g., acceptable percentage change over time) and precision (e.g., maximum coefficient of variation). The "ground truth" for these tests is whether the measured performance falls within these predefined acceptable ranges.
The document does not explicitly detail the specific reference methods or internal specifications used to establish ground truth for each performance study.
8. The Sample Size for the Training Set
This information is not applicable. The Liberty Control Solutions are chemical control solutions, not machine learning algorithms or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #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.