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510(k) Data Aggregation
(244 days)
The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The POGO Automatic Blood Glucose Monitoring System (POGO BGMS) is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value.
The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. The blood sample is drawn into the test through capillary action and the meter, by monitoring the time and degree of blood spreading on the reagent pad, can detect when the test is under-filled and allow the user a limited amount of time to add blood to the test trip to obtain a glucose result rather than an error. Additionally, used tests are retained within the cartridge for added user convenience. Control solutions are available to confirm correct system performance.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (from FDA Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, October 2016) | Reported Device Performance (POGO BGMS Self-Test Glucose Results) |
|---|---|
| Accuracy relative to YSI reference: | |
| For glucose concentrations < 75 mg/dL: | |
| All data within ±15 mg/dL bias to the plasma YSI reference results. | 100% of POGO BGMS self-test glucose results were within ±15 mg/dL of the reference YSI results at a glucose concentration of <75 mg/dL for both Automated and Reapplication results. |
| For glucose concentrations ≥ 75 mg/dL: | |
| At least 95% of results within ±15% of the YSI reference. | At glucose concentrations of ≥75 mg/dL, 95.0% of POGO BGMS self-test glucose results were within ±15% of the reference YSI (95.8% Automated and 91.5% Reapplication). |
| (Implicitly, better than 95% within ±20% is also typically expected) | 99.2% of POGO BGMS results were within ±20% of the reference YSI (99.1% Automated and 100% Reapplication). |
| Reapplication Feature Accuracy (implied by additional studies): | The overall results from each study demonstrated at least 95% of results within 15% (for glucose > 75mg/dL) or 10 mg/dL (for glucose < 75mg/dL) of the YSI when used in Reapplication Mode. |
The document states, "These results met the predetermined accuracy specifications."
Study Details
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Lay User Evaluation (initial study):
- Sample Size: 285 subjects with diabetes.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "multi-site" study, suggesting it was prospective clinical data.
- Additional Reapplication Studies:
- Sample Size: 215 data points were obtained in total.
- Data Provenance: The document does not explicitly state the country of origin. It indicates these were "clinical studies" where "lay users tested," suggesting prospective clinical data.
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)
The ground truth was established using a YSI reference. YSI is a laboratory-grade glucose analyzer, not an expert panel. Therefore, no human experts were involved in establishing the ground truth for comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There was no human adjudication as the ground truth was established by a YSI laboratory reference.
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 involving human readers and AI assistance was not performed. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies evaluated the standalone performance of the POGO Automatic Blood Glucose Monitoring System. The results provided are for the device (algorithm and hardware) directly compared to the YSI reference, representing its intrinsic accuracy without human interpretation influencing the numerical glucose value. The "self-test data" implies users operated the device themselves, but the performance metrics are about the device's accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was plasma YSI reference results. YSI (Yellow Springs Instruments) analyzers are commonly used as "gold standard" or laboratory reference methods for glucose measurement in clinical studies due to their high accuracy and precision.
8. The sample size for the training set
The document does not provide specific details about a training set for an algorithm. It discusses "nonclinical data" where "IMI obtained 60 POGO BGMS whole blood results via intermittent sampling at nominal glucose levels from 60 to 225 mg/dL. All data were within ±15% bias to the plasma YSI reference results." This sounds more like a verification or early validation step rather than a formal, large-scale training set for a machine learning model. The device's "photometric" detection method and "glucose oxidase" enzyme suggest a more traditional biochemical assay rather than a complex AI algorithm that typically requires a large training dataset in the context of AI/ML devices.
9. How the ground truth for the training set was established
As mentioned above, the available information describes a nonclinical dataset where results were compared against "plasma YSI reference results." This indicates the YSI system was also used as the ground truth for this nonclinical testing, similar to the clinical studies.
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