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510(k) Data Aggregation
(147 days)
BD Logic™ and Paradigm Link™ Blood Glucose Monitors are intended to be used for the quantitative measurement of glucose in whole blood. The monitors are intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. BD monitors are not intended for use in the diagnosis of or screening for diabetes mellitus and are not intended for use on neonates.
BD Logic™ and Paradigm Link ™Blood Glucose Monitors are specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, palm, and forearm.
BD Logic and Paradigm Link Blood Glucose Monitors are intended for use in the quantitative measurement of glucose in capillary blood collected from the fingertip, palm and forearm.
BD Logic and Paradigm Link Blood Glucose Monitors are designed to be simple and easy to use. The monitors provide accurate blood glucose test results in 5 seconds using a small (0.3 uL) sample volume. The lancing device is available with a standard adjustable depth setting lancet cap and an off-finger lancet cap with a set lancing depth.
BD Logic and Paradigm Link Blood Glucose Monitoring Systems work by using biosensor technology. When blood is applied to the Blood Glucose Test Strip, reagents on the test strip react with the blood and a current is generated. BD Logic and Paradigm Link Blood Glucose Monitoring Systems employ amperometric technology to measure the glucose concentrations in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.
The provided text describes the BD Logic™ and Paradigm Link™ Blood Glucose Monitors and their performance. However, it does not contain specific details about acceptance criteria or a study design that comprehensively demonstrates meeting those criteria. The "Performance Summary" section is a high-level statement rather than a detailed report.
Based on the available text, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria for accuracy. However, it does highlight key performance aspects:
| Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|
| Accuracy (General) | "The monitors provide accurate blood glucose test results" (Device Description) |
| Accuracy (Alternate Site Testing - AST) - Steady State | "Clinical studies... demonstrate that BD Logic and Paradigm Link Blood Glucose Monitoring Systems are suitable for fingertip, palm or forearm testing when performed in accordance with the device labeling." (Performance Summary) |
| Accuracy (Alternate Site Testing - AST) - Dynamic Glycemic Change | "Clinical studies... demonstrate that during period of rapid glucose change, testing on the palm is equivalent to fingertip testing." (Performance Summary) |
| Test Time | "5 seconds" (Device Description) |
| Sample Volume | "small (0.3 uL)" (Device Description) |
Study Details (Based on available information):
Based on the provided text, a detailed study design meeting all the requested criteria is not present. The "Performance Summary" section refers to "Clinical studies" generally.
1. Sample sized used for the test set and the data provenance:
* Sample Size: Not specified in the provided text.
* Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The mention of "Clinical studies were conducted" suggests prospective data collection, but this is not definitively stated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts: Not specified.
* Qualifications: Not specified. The studies involved comparison to a reference method, which is the implicit "ground truth," but the nature of the reference method and its operators (experts) are not detailed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not specified. Adjudication methods are typically relevant for subjective assessments (e.g., interpreting images), not for quantitative measurements like blood glucose, where a reference laboratory method usually serves as the "ground truth."
4. 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:
* MRMC Study: No. This type of study (MRMC, AI assistance) is not applicable to a blood glucose monitor, which is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, this device is inherently a standalone algorithm/device. The performance discussed in the "Performance Summary" refers to the device's accuracy in measuring glucose levels.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "Performance Summary" states "Clinical studies were conducted to evaluate the use...". For blood glucose monitors, the ground truth is typically established by comparison to a reference laboratory method (e.g., a YSI glucose analyzer) rather than expert consensus, pathology, or outcomes data, but this specific detail is not present in the provided text.
7. The sample size for the training set:
* This information is not provided. For a device like a blood glucose monitor, the term "training set" might not apply in the same way it does for machine learning models (i.e., there isn't typically an "algorithm" being trained on a specific data set to achieve its core function; rather, the device is designed and calibrated).
8. How the ground truth for the training set was established:
* Not applicable/not specified, as a distinct "training set" in the context of machine learning is not mentioned. The device's calibration and accuracy would be verified against established laboratory methods during its development.
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