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The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.

The OK Meter Blood Glucose Monitoring System based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. The OK Meter Blood Glucose Monitoring System only needs a 0.7 ul small amount of blood. Capillary action both side near the end of the test strip that draws the blood into the action chamber and the blood glucose result is precisely and displayed in 6 seconds.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

The provided documents describe the "OK Meter Blood Glucose Monitoring System" and its 510(k) submission. However, the document is notably lacking detailed information regarding specific acceptance criteria and the results of a study designed to explicitly prove the device meets those criteria. The information provided focuses on general claims of substantial equivalence to a predicate device and a brief description of the device's technology.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics (e.g., accuracy percentages, precision data, agreement rates, etc.). It generally states that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." However, the actual data or the acceptance thresholds are absent.

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 given text.

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 information is not provided in the given text. For blood glucose meters, the "ground truth" would typically refer to results from a laboratory reference method, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used when human interpretation is involved in establishing ground truth for subjective outcomes (e.g., radiology reads). For a blood glucose meter, the reference method provides a direct, objective measurement.

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. The device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size" of AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device operates as a standalone system. The text states: "The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use)." This directly implies standalone performance by the device itself to produce a quantitative measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "type of ground truth used," but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., a YSI analyzer), known for their high accuracy and precision, against which the device's measurements are compared.

8. The sample size for the training set

This information is not provided in the given text. For a device based on an electrochemical biosensor, the "training set" might refer to data used for calibrating the sensor and developing the algorithm that converts electrochemical signals into glucose concentrations.

9. How the ground truth for the training set was established

This information is not provided in the given text. Similar to the test set, the ground truth for any calibration or development data would typically be established using highly accurate laboratory reference methods.

Summary of what is available and what is missing:

The document serves as a 510(k) summary, which is typically a high-level overview. While it states that pre-clinical and clinical data were submitted, it does not disclose the detailed results of those studies, the specific acceptance criteria for performance, sample sizes, or the methodology for establishing ground truth beyond the general mention of following FDA guidance for IVD test systems. The primary claim of "substantial equivalence" is made based on shared working principles and technologies with the predicate device, implying that if the predicate device met performance standards, then the OK Meter, by being substantially equivalent, would also be expected to meet similar standards.

To obtain the detailed information requested, one would need to review the full 510(k) submission (K063026) which would contain the detailed study reports and data.

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