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510(k) Data Aggregation
(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 Contour Blood Glucose Monitor.
The FDTX Glucose Control Solution 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 a 510(k) submission for the FDTX Glucose Control Solution. While it outlines the device's purpose and general performance studies, it does not contain the detailed acceptance criteria or the specific results of those studies that would precisely demonstrate the device meets those criteria.
However, based on the information provided, we can infer some aspects and construct a table of claimed performance, acknowledging that specific numerical acceptance criteria are missing. The study is a comparison to predicate devices and performance studies were conducted to show substantial equivalence.
Here's an attempt to answer your request based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Claimed/Implied) |
|---|---|
| Intended Use: For in vitro diagnostic use by healthcare professionals and people with diabetes mellitus to assess the performance of the Bayer Ascensia Contour Blood Glucose Monitor. | Matches Intended Use of Predicate: "To check the performance of the Ascensia Contour Blood Glucose System." (Directly comparable to predicate devices' intended use) |
| Analyte: Contains glucose. | Contains Glucose: "viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose." |
| Number of Levels: Comparable to predicate devices (1 level). | 1 Level: Matches predicate devices. |
| Target Range (mg/dL): Within a clinically acceptable range for glucose control solutions, comparable to predicate devices. | 100 - 145 mg/dL: Comparable to predicate devices (100-143 mg/dL and 90-130 mg/dL). |
| Physical Characteristics (Container, Volume, Color): Similar to predicate devices for user familiarity and compatibility. | Plastic bottle with dropper-tip, 3.6 mL, Red: Matches predicate device characteristics. |
| Matrix: Aqueous solution with specific components (viscosity modifier, preservatives, non-reactive ingredients) | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients: Matches predicate device 2's matrix. |
| Safety: Non-hazardous, no human/animal derived materials. | Non-hazardous and contains no human or animal derived materials. |
| Stability (Accelerated): Maintains specified performance over time under accelerated conditions. | "Tests were performed to verify specific performance characteristics: 1. Accelerated Stability" (Implies successful verification, but no data provided) |
| Open Vial Stability: Maintains specified performance after the vial is opened for a defined period. | "Tests were performed to verify specific performance characteristics: 2. Open Vial" (Implies successful verification, but no data provided) |
| Precision: Demonstrates acceptable level of consistency in results. | "Tests were performed to verify specific performance characteristics: 3. Test precision" (Implies successful verification, but no data provided) |
| Substantial Equivalence: Demonstrated to be as safe and effective as a legally marketed predicate device. | "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." (Conclusion of the submission) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The text only mentions "Tests were performed to verify specific performance characteristics." This implies specific samples (e.g., lots of control solution, measurements taken) were used but their size is not disclosed.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the FDA, it would be laboratory data generated by the manufacturer (Fujirebio Diagnostics Texas, Inc.). It's likely prospective testing conducted in a controlled lab environment. No information on country of origin for the data is provided beyond the company's location in Texas, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a control solution, not a diagnostic AI or imaging device that requires expert interpretation for ground truth. The "ground truth" for a control solution is typically the assigned value of the analyte (glucose) within the control solution, determined by a reference method or validated analytical process.
- Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic interpretation (e.g., radiologists) is not applicable here. The ground truth for the glucose concentration would be established through chemical analysis methods rather than expert consensus on images or pathological findings.
4. Adjudication method for the test set
- Not applicable as the and evaluation of performance characteristics for a control solution does not involve "adjudication" in the sense of reconciling differing expert opinions on a diagnostic case. The performance is assessed against established analytical methods and statistical criteria.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging AI) where human interpretation is involved. The FDTX Glucose Control Solution is a quality control material for a blood glucose monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the FDTX Glucose Control Solution. It is a physical control solution, not an algorithm or AI device. Its performance is evaluated through its chemical stability, accuracy, and precision when used with a blood glucose monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the FDTX Glucose Control Solution is the assigned glucose concentration within the solution, determined by a validated analytical method and internal quality control processes. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. This device is a control solution, a physical product, not an AI/ML algorithm that requires a "training set." The product's characteristics are developed through chemical formulation and analytical testing, not machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for this device, the concept of establishing ground truth for it is irrelevant.
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