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The Genesis Health Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper-arm. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended to be used by a single person and should not be shared.

The Genesis Health Technologies test strips are for use with the Genesis Health Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.

The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The Genesis Health Technologies control solutions are for use with the Genesis Health Blood Glucose meter and test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

The provided text describes a 510(k) submission for a blood glucose monitoring system. Crucially, it does not provide explicit acceptance criteria with specific numerical thresholds for accuracy, nor does it detail a standalone study proving the device meets new acceptance criteria.

Instead, the submission for the Genesis Health Technologies Blood Glucose Monitoring System (model TD-4123) is based on demonstrating substantial equivalence to a predicate device, the U-RIGHT TD-4252 Blood Glucose Monitoring System (K101631). This means the focus of the "study" described is to show that the new device performs similarly or identically to an already approved device, rather than meeting a new, independently established set of performance targets.

Therefore, the table and other information below are derived from the available information, noting the absence of certain details that would be present in a submission proving performance against novel acceptance criteria.

1. Table of Acceptance Criteria (Implied by Substantial Equivalence to Predicate) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate device that the new device aims to match. The "reported device performance" is the claim that the new device performs equivalently based on comparative testing.

Note: The "Differences" listed (e.g., power source, battery recharging, measurement unit, test strip indication light, backlight, special message, measurement mode, QC storage, day average, size, weight, data transmission capable) are modifications. For these, the claim is that despite these differences, the core performance characteristics (especially accuracy) remain equivalent.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text for the comparative accuracy study.
• Data Provenance: Not explicitly stated. Given the manufacturer is based in Taiwan, it's plausible the study was conducted there, but this is not confirmed. The text does not specify if the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of this submission. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer), not by expert consensus readings of images or clinical assessments. The submission does not detail the reference method or the personnel performing the reference tests.

4. Adjudication Method for the Test Set

Not applicable/not provided. As mentioned above, ground truth for blood glucose is typically a laboratory reference measurement, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. MRMC studies are typically for image interpretation tasks where different human readers interpret cases. Blood glucose monitoring systems are automated devices, and their performance is evaluated against a laboratory reference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "system accuracy performance" comparison would inherently be a standalone assessment of the device (meter and test strip) against a reference standard. The text states:

• "A comparison of system accuracy performance demonstrated that the Genesis Health Technologies Blood Glucose Monitoring System and the U-RIGHT TD-4252 Blood Glucose Monitoring System are substantially equivalent."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the Genesis Health Technologies Blood Glucose Monitoring System are equivalent to the predicate device."

These statements indicate testing of the device's inherent performance.

7. The Type of Ground Truth Used

The text strongly implies that the ground truth for "system accuracy performance" was an objective laboratory reference method. For blood glucose meters, this typically involves comparing the meter's readings to a validated laboratory analyzer (e.g., a YSI STAT PLUS Glucose & L-Lactate Analyzer) which provides highly accurate glucose measurements from the same blood samples. The exact reference method is not specified, but it would not be expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. The Genesis Health Technologies Blood Glucose Monitoring System is a hardware-based electrochemical biosensor system with integrated software. It is not described as an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software modifications" mentioned would have undergone software verification and validation, but not "training" on a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.

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