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The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by a single person and should not be shared.

The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.

The Wow GoHealth Blood Glucose Monitoring System (Model GSH-BGM902) 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 WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is a product kit consisting of a blood glucose meter (meter), test strips, a lancing device, lancets, and instructions for use. Control solution Level 1, Level 2 or 3 are available and sold separately. When glucose reacts with the reagents on the test strips, an electrical current is produced. The current is proportional to the glucose concentration in the blood sample. The meter will calculate glucose concentration based on the current measured. The device can show results either in "mg/dL" or "mmol/L". The factory set default for the meter is mg/dL. Apart from the existing measurement features and user interface of the device's predicate, the device is featured with Bluetooth mediated data transmission functionality which wirelessly transfers the latest test result to an APP run on a mobile device every time when a test is performed successfully.

The provided document is a 510(k) premarket notification for the WowGoHealth Blood Glucose Monitoring System, Model GSH-BGM902. It describes the device, its intended use, and compares it to a predicate device. The document primarily focuses on demonstrating substantial equivalence through technical characteristics and a summary of design control activities/testing, rather than providing detailed clinical study results to prove specific performance acceptance criteria for the entire device.

This document describes a "Special 510(k)" submission, which is for minor modifications to a previously cleared device. As such, detailed clinical performance studies, such as those that would typically establish the initial performance criteria and prove their met, are generally not included in these types of submissions, since the fundamental technological characteristics are considered largely unchanged. The focus is on demonstrating that the modifications do not adversely affect safety or effectiveness.

Therefore, much of the requested information regarding acceptance criteria and a study to prove the device meets the acceptance criteria (especially clinical performance data for accuracy against a reference method) is not present in the provided text. The document refers to "similar acceptance criteria" to the predicate, implying that the predicate's performance has already been established.

However, I can extract information related to the modifications and their verification:

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

The document does not provide a specific table of acceptance criteria for overall device performance (e.g., accuracy against a lab reference method for glucose measurement), nor detailed reported device performance for these parameters. It focuses on the equivalence to the predicate.

For the modifications, the acceptance criteria are implicitly that the new features function as intended and do not introduce unacceptable risks. The document states:

• "The analyses revealed that the modifications required similar V&V testing to the predicate SuperCheck Plus device, with similar acceptance criteria, as testing revealed no significant additional risk from the modifications."
• "Testing was performed to establish that design outputs met pre-established design inputs as per design specifications (verification), specifically for the Bluetooth mediated data transmission functionality feature."
• "Design validation ensured that the design meets user needs, and validation activities were conducted as necessary (per 21 CFR820.30)."

The "reported device performance" for the new features is described by their functionality:

• Reposition of the control test flag ("cotr"): This is a visual change on the meter display. The "performance" is that it displays "cotr" instead of "C". (Fig. 3)
• Bluetooth mediated data transmission functionality: The meter "has the capability to wirelessly transfer the latest test result to an APP run on a mobile device every time when a test is performed successfully." If data transmission fails, the user can manually enter it. During transmission, "bLE" and test time flash alternately. (Fig. 4)
• Change of meter's housing color: The quality of housing materials is unchanged, only the color from black to white. (Fig. 5)

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

The document does not specify general "sample sizes" for a clinical test set in the way one might expect for a de novo submission establishing accuracy. It mentions specific testing related to the modifications:

• Usability study on Bluetooth functionality: A usability study was conducted, but the sample size is not stated.
• Bench study on robustness to cleaning/disinfection: This study was conducted, but the sample size (number of devices/test cycles) is not stated.
• Safety and reliability testing, EMC testing, and FCC testing: These were performed by "qualified outsourced labs" using "protocols following applicable CDRH guidelines and related standards." No sample sizes or data provenance (country, retrospective/prospective) are specified for these.

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. The document does not describe the establishment of ground truth for glucose measurements, as this would typically be established for the foundational technology (the predicate device) or within an accuracy study, which is not detailed here.

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

Not applicable. This document does not describe a clinical study that would require adjudication of expert readings or similar methods.

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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device.

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

This refers to the performance of the device itself. The document implicitly relies on the performance of the predicate device for the core glucose measurement accuracy, stating that the "fundamental scientific technology... remains unchanged." Specific standalone accuracy results for this modified device are not provided in the scope of this Special 510(k).

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 for performance validation of the core glucose measurement, as this would have been established for the predicate device (K141351). For blood glucose meters, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) with traceable standards. For the modifications, the "ground truth" for the Bluetooth functionality is whether data is successfully transmitted and displayed, and for robustness, whether the device withstands cleaning/disinfection.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

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

Not applicable.

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