(228 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto 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 Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.
The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. 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 multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.
The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.
The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose. The BGM014 Pro blood glucose meter and BGM014 Pro test strips are used for professional testing of blood glucose.
The provided text describes the BGM014 Blood Glucose Monitoring System and BGM014 Pro Blood Glucose Monitoring System. Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it implicitly indicates that the device's performance must demonstrate "substantial equivalence to the predicate system" based on various tests. For blood glucose monitoring systems, this typically aligns with accuracy standards set by organizations like ISO or FDA guidance documents. The study results are reported as meeting this substantial equivalence.
Implied Acceptance Criteria (based on common standards for blood glucose meters) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy within acceptable limits compared to reference method (e.g., laboratory analyzer) | "Results demonstrate substantial equivalence to the predicate system." |
| Precision within acceptable limits | Precision testing was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Linearity across the measuring range | Linearity testing with validation of Lo/Hi detection was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Performance under varying environmental conditions (temperature, humidity, altitude) | Temperature and humidity testing, altitude testing were conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Performance with varying hematocrit levels | Hematocrit performance testing was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| No significant interference from common substances | Interference testing was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Disinfection robustness | Disinfection performance (robustness of meter to multiple cleanings and disinfections) was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Software verification and validation | Software verification and validation was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Sample volume verification | Sample volume verification was conducted. "Results demonstrate substantial equivalence to the predicate system." |
| Qualification of control solutions | Qualification of control solutions was conducted. "Results demonstrate substantial equivalence to the predicate system." |
Study Details:
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Sample size used for the test set and the data provenance:
- The document states: "An accuracy study was conducted with home users and professional users using finger, palm and forearm capillary whole blood. Venous blood testing was also done by the professional users."
- However, the specific sample sizes for the test sets are not provided in the given text.
- The data provenance (e.g., country of origin, retrospective or prospective) for the clinical study is not explicitly stated. It's implied to be prospective as it's an "accuracy study conducted with home users and professional users."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. For blood glucose monitoring systems, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by "experts" in the sense of radiologists.
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Adjudication method for the test set:
- This information is not provided as it's not typically relevant for blood glucose meter accuracy studies where direct comparison to a reference method is used.
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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:
- This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. Therefore, a MRMC comparative effectiveness study is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device functions as a standalone blood glucose meter. The "accuracy study" inherently represents the standalone performance of the device without human interpretation (beyond the user applying the blood sample and reading the displayed result).
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The type of ground truth used:
- While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., a YSI analyzer) which is considered highly accurate.
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The sample size for the training set:
- This is a medical device for measuring blood glucose, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set."
§ 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.