(14 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 Liberty Glucose Control consists of a viscosityadjusted, 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 510(k) summary for the Liberty Glucose Control device does not contain specific acceptance criteria with numerical thresholds, nor does it detail a comprehensive study with reported device performance against such criteria. The document states that "Tests were performed to verify specific performance characteristics" including "1. Stability (Accelerated and Real-time), 2. Open Vial, 3. Microbial Stress Stability, 4. Test precision." However, it does not provide the results of these tests or the predefined acceptance limits.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on a comparison of characteristics and general performance categories.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states that "Tests were performed to verify specific performance characteristics" but does not enumerate the acceptance criteria for these tests nor report the specific performance values obtained from these tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "Tests were performed," but no details about sample sizes, study design (retrospective/prospective), or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and therefore not provided. The device is a "Single Analyte Control Solution," meaning it's a quality control material with a known quantity of glucose. The "ground truth" for this type of device would be the established concentration of glucose in the control solution itself, determined through analytical chemistry methods, not expert consensus on diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and therefore not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a quality 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
This is not applicable and therefore not provided. The device is a glucose control solution, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and therefore not provided. The device is a physical control solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a glucose control solution is the established, precisely measured concentration of glucose within the control solution itself, determined through laboratory analytical methods.
8. The sample size for the training set
This is not applicable and therefore not provided. The device is a quality control material and does not involve AI or machine learning, thus there is no "training set."
9. How the ground truth for the training set was established
This is not applicable and therefore not provided. As there is no training set for this type of device, the concept of establishing ground truth for it does not apply.
Summary based on available information:
The 510(k) summary for the Liberty Glucose Control focuses on demonstrating substantial equivalence to predicate devices (TheraSense FreeStyle Control K031260 and Liberty Glucose Control K052980) based on shared characteristics and intended use. While it mentions performance studies (Stability, Open Vial, Microbial Stress Stability, Test Precision), it does not provide explicit acceptance criteria, detailed study designs, or the quantitative results of these studies.
The "study that proves the device meets the acceptance criteria" is broadly stated as "Performance Studies: Tests were performed to verify specific performance characteristics." However, no specific data or direct comparisons against pre-defined acceptance criteria are presented in this summary document. The conclusion states that "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," implying that general performance testing was conducted and deemed acceptable, but the specifics are not disclosed in this public summary.
§ 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.