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The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) consists of the NuvoMed Wireless Blood Glucose Monitor and the NuvoMed Blood Glucose Test Strip. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used by a single person and should not be shared.

The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) 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 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) 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 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is a product kit consisting of a blood glucose meter, test strips, a lancing device, sterile lancets, instructions for use, and a carrying case. No control solution is included in the kit; however, user may purchase NuvoMed Control Solution Level 1, 2 or 3 from his/her system provider if needed. The NuvoMed Blood Glucose Meter uses NuvoMed Blood Glucose Test Strips. Neither the meter nor the test strips will work when used with any other brand of glucose products.

I am sorry, but the provided text does not contain the specific details about the acceptance criteria and the comprehensive study results (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) that would be needed to fulfill all aspects of your request.

The document is a 510(k) premarket notification for a medical device (NuvoMed Wireless Blood Glucose Monitoring System) and primarily focuses on demonstrating substantial equivalence to a predicate device. While it mentions "Verification and Validation Activities" and "similar acceptance criteria" to the predicate, it does not explicitly list these criteria or provide detailed study data.

Here's what I can extract and what is missing:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria (Implied/General): The document states that "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)." It also mentions "similar acceptance criteria" to the predicate device. However, the specific numerical or qualitative acceptance criteria are not detailed in the provided text.
• Reported Device Performance: The document confirms that the device was tested and "All the documents, including test reports, referenced are on file at Biotest Medical Corporation." It also states, "Verification and validation testing showed the risk control to be acceptable." However, the actual performance metrics (e.g., accuracy, precision, bias) are not reported in the provided text.

2. Sample sized used for the test set and the data provenance:

• Missing: The document does not specify the sample sizes used for any of the verification and validation tests.
• Missing: Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned for any test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable/Missing: For a blood glucose monitoring system, the "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert consensus on images or interpretations. The document does not mention the type or number of experts for ground truth establishment.

4. Adjudication method for the test set:

• Not Applicable/Missing: As the ground truth is not established by human review/interpretation in this context, adjudication methods are not relevant or mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable: This device is a blood glucose meter, not an AI-powered diagnostic imaging system that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant and not mentioned.

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

• Partially Applicable, but details missing: The device itself acts as a "standalone" algorithm for measuring glucose. The document confirms that "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." However, the results and detailed methodology of this "standalone" performance for glucose measurement (e.g., accuracy against a reference method) are not provided.

7. The type of ground truth used:

• Implied (but not explicitly stated): For blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI glucose analyzer). This type of information is generally part of the analytical and clinical performance studies, which are alluded to but not detailed in this 510(k) summary.

8. The sample size for the training set:

• Not Applicable/Missing: This device is not described as using a machine learning model that would require a "training set" in the conventional AI sense. The "training" here would refer to the device's factory calibration and design, not an AI model.

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

• Not Applicable/Missing: See point 8.

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a medical device. It states that verification and validation activities were performed and that the device meets its design inputs and user needs. However, it does not provide the detailed acceptance criteria, specific study results, sample sizes, ground truth establishment methods, or other in-depth study information that your request asks for. This level of detail would typically be found in the full test reports referenced in the submission but are not part of this summary document.

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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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