(30 days)
The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.
The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose.
The provided text is a 510(k) Premarket Notification from the FDA regarding the BGM014 Blood Glucose Monitoring System. It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.
However, the core of the request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI-based medical device or a device requiring complex performance evaluation typically involving expert adjudication, MRMC studies, or extensive ground truth establishment.
The provided document does not contain any information about an AI-based device, nor does it detail complex study designs with human readers, expert ground truth establishment, or clinical performance studies of the type requested.
Instead, this document is a clearance letter for a blood glucose monitoring system, which is a type of in vitro diagnostic device. The performance evaluation for such devices primarily focuses on analytical accuracy (how well the device measures glucose compared to a reference method) and often basic usability/disinfection efficacy, rather than the intricate clinical performance assessment typical for AI/CADe systems.
Therefore, it is not possible to answer the specific questions about acceptance criteria and study design as requested for an AI/CADe device using the provided text.
Here's what the document does state regarding testing and equivalence:
- Non-Clinical Testing: "Disinfection (viral inactivation) and 'robustness' testing were done to qualify the recommended disinfection solutions. Results demonstrate substantial equivalence to the predicate."
- Clinical Testing: "No clinical testing was conducted."
- Conclusion: "Testing showed that the modified BGM014 Blood Glucose Monitoring Systems are substantially equivalent to the predicate."
This indicates that the clearance was largely based on non-clinical testing demonstrating the device's ability to handle new disinfection solutions, asserting its continued substantial equivalence to a previously cleared device (K161299). The "acceptance criteria" for a blood glucose meter would typically involve accuracy metrics (e.g., % of results within certain error margins of a lab reference method, often based on ISO standards), but these specific performance statistics are not detailed in this 510(k) clearance letter. The letter confirms the device meets the regulatory requirements for substantial equivalence, implying it meets the necessary performance standards, but doesn't list them.
To reiterate, the detailed questions about expert adjudication, MRMC studies, standalone AI performance, ground truth sources (pathology, outcomes), and training set information are not applicable to the type of device and information presented in this FDA clearance 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.