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510(k) Data Aggregation
(357 days)
The OKmeter Direct 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, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The OKmeter Direct 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 OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.
Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Direct Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 6 seconds.
Here's a breakdown of the acceptance criteria and study details for the OKmeter Direct Blood Glucose Monitoring System, as extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for glucose meters are typically defined by regulatory bodies like the FDA, often referring to standards like ISO 15197. While the document doesn't explicitly state "acceptance criteria" numbers as a separate table, it presents performance data in a way that implies these are the criteria against which the device is being tested for accuracy. The core criteria revolve around the percentage of results falling within specific deviation ranges from a reference method (YSI 2300).
The performance data is presented separately for two user groups: "Home Users" (lay users) and "Healthcare Professionals."
For Glucose Concentration < 75 mg/dL (4.2 mmol/L):
| Acceptance Criteria (Deviation from Reference) | Lay Users Performance (Range: Fingertip to Thigh) | Healthcare Professionals Performance (Range: Fingertip to Thigh) |
|---|---|---|
| Within ±5 mg/dL (±0.28 mmol/L) | 67% - 86% | 67% - 81% |
| Within ±10 mg/dL (±0.56 mmol/L) | 95% - 100% | 95% - 100% |
| Within ±15 mg/dL (±0.83 mmol/L) | 100% | 100% |
For Glucose Concentration ≥ 75 mg/dL (4.2 mmol/L):
| Acceptance Criteria (Deviation from Reference) | Lay Users Performance (Range: Fingertip to Thigh) | Healthcare Professionals Performance (Range: Fingertip to Thigh) |
|---|---|---|
| Within ±5% | 58% - 73% | 59% - 74% |
| Within ±10% | 84% - 100% | 85% - 100% |
| Within ±15% | 96% - 99% | 96% - 97% |
| Within ±20% | 100% | 100% |
Summary of Reported Performance (Across all alternative sites and user types, presenting the minimum reported compliance):
| Glucose Concentration Range | Accuracy (Within ±5 mg/dL or ±5%) | Accuracy (Within ±10 mg/dL or ±10%) | Accuracy (Within ±15 mg/dL or ±15%) | Accuracy (Within ±20% for ≥ 75 mg/dL) |
|---|---|---|---|---|
| < 75 mg/dL (4.2 mmol/L) | 67% (Forearm/Upper arm/Calf) | 95% (Palm/Forearm/Upper arm/Calf) | 100% | Not applicable |
| ≥ 75 mg/dL (4.2 mmol/L) | 58% (Calf) | 84% (Thigh) | 96% (Palm/Forearm/Upper arm/Calf/Thigh) | 100% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 135 patients
- Data Provenance: The document does not explicitly state the country of origin. The manufacturer is "OK Biotech Co., Ltd." based in "Hsin Chu City, Taiwan, ROC." It is reasonable to infer the study might have been conducted in Taiwan, but this is not definitively stated.
- Retrospective or Prospective: The document does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth was established by a YSI 2300 Analyzer. This is a laboratory reference instrument, not a human expert. Therefore, the concept of "number of experts" and their qualifications for establishing ground truth does not directly apply in the human sense.
4. Adjudication Method for the Test Set
- Since the ground truth was established by an objective laboratory instrument (YSI 2300 Analyzer), no human adjudication method (like 2+1, 3+1) was required. The device's readings were directly compared to the YSI 2300 readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document describes a study comparing the device's performance to a reference standard (YSI 2300) when used by both lay users and healthcare professionals. While different user groups ("readers") are involved, this is not a traditional MRMC comparative effectiveness study designed to measure the improvement of human readers with AI vs. without AI assistance. It's a performance study of the device itself under different user scenarios.
- Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The entire study presented quantifies the accuracy of the OKmeter Direct Blood Glucose Monitoring System (the algorithm/device) against a reference standard (YSI 2300 Analyzer). The metrics (e.g., % within ±5 mg/dL or ±5%) are direct measurements of the device's accuracy.
7. Type of Ground Truth Used
- The ground truth used was established by a laboratory reference method: the YSI 2300 Analyzer. This is a highly accurate instrument used for glucose measurement in clinical settings.
8. Sample Size for the Training Set
- The document does not provide information regarding a training set sample size. The data presented is for the evaluation of the final device rather than its development.
9. How the Ground Truth for the Training Set Was Established
- Since information on a training set is not provided, how its ground truth was established is not available in this document.
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