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Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.

Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.

Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.

This test can not be used to screen or diagnose diabetes.

It should not be used for children or by individuals who are diabetic or pregnant.

This test is only intended for individual use at home.

It is not for use as part of a screening program in a healthcare setting or any other setting.

Reagent test principle - glucose oxidase

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) premarket notification summary for the Betachek Blood Glucose Test, primarily focusing on establishing substantial equivalence to a predicate device.

While it mentions "Performance Characteristics" and "clinical evaluations," it does not provide the specific numerical acceptance criteria for performance metrics (like accuracy or precision) nor the detailed results of a study to demonstrate these. The document states, "Betachek Blood Glucose Test has the same intended use and technological characteristics as the predicate device and clinical evaluations demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This general statement of equivalence is not a report of specific performance criteria and study results.

Therefore, many of the requested fields cannot be filled. However, based on the provided text, here's what can be extracted and what cannot:

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

Explanation: The document states the Betachek Blood Glucose Test has the "same intended use and technological characteristics" as the predicate. The operational parameters like Test Range and Test Time are listed as identical to the predicate, implying these are the "performance" that matched the "acceptance criteria" (which would be meeting the predicate's performance). However, explicit numerical accuracy, precision, or other performance acceptance criteria are not provided, nor are specific study results for these metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document mentions "clinical evaluations" but gives no details about where, when, or how these were conducted.

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)

• Not applicable/Not specified. The device is a "Glucose Test System" for a finger-stick blood sample, which typically relies on a chemical reaction for the result, not expert interpretation of images or other subjective data requiring ground truth established by experts in that manner. Any reference method used for comparison would be a laboratory instrument.

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

• Not applicable/Not specified, for the same reason as point 3.

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

• Not applicable. This is a blood glucose test, not an AI-assisted diagnostic imaging device.

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

• Not applicable. This is a self-use, non-instrumented test strip. The "performance" is the result obtained directly from the chemical reaction on the strip.

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

• Not explicitly stated, but for a blood glucose test, the "ground truth" (or reference method) would typically be quantitative laboratory reference methods as hinted at in the Intended Use: "Any abnormal results should be verified by a medical professional... and confirmed with a quantitative, laboratory reference method."

8. The sample size for the training set

• Not applicable. This device is not described as utilizing machine learning or AI that would require a "training set."

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

• Not applicable, as there is no training set described.

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