(93 days)
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.