(24 days)
The EasyMax BT Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EasyMax BT meter and the EasyMax BT test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The modified device of EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The system also includes the control solution which is used to check the performance of the system.
The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
The provided text is a 510(k) premarket notification for the EasyMax BT Self-Monitoring Blood Glucose System. It outlines the device's intended use, comparison to a predicate device, and the design control activities undertaken for modifications.
However, the document does not contain specific acceptance criteria tables nor detailed performance study results (accuracy, precision, or clinical performance data) that would typically be used to prove the device meets these criteria. It primarily focuses on the regulatory submission process, risk analysis, and verification/validation activities that address the addition of a Bluetooth dongle and associated software changes, rather than the core accuracy or clinical performance of the blood glucose measurement itself.
The document mentions that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission." This indicates that such data exists in other reports submitted to the FDA, but it is not present in this public summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, expert involvement, adjudication, or specific performance study types like MRMC or standalone studies.
Based only on the provided text, here's what can be inferred or stated:
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1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states that "similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission." This implies that performance data exists in other, unprovided reports.
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2. Sample sized used for the test set and the data provenance: Not provided in the document.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This device measures glucose, a quantitative value, not interpreted by experts in the typical sense of imaging. The ground truth would be established by a reference laboratory method.
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4. Adjudication method for the test set: Not applicable or not provided.
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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 is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement system for glucose. The performance of the blood glucose measurement itself would be a standalone assessment against a reference method. However, the details of such a study are not provided in this document.
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7. The type of ground truth used: For a blood glucose monitoring system, the ground truth is typically a laboratory reference method (e.g., YSI analyzer) for blood glucose concentration. This is not explicitly stated but is standard for such devices.
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8. The sample size for the training set: Not applicable. This is not an AI/ML device in the sense of modern deep learning, but rather an electrochemical device. There isn't a "training set" in the common AI/ML context.
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9. How the ground truth for the training set was established: Not applicable.
What the document DOES discuss related to "acceptance criteria" and "proof":
The document focuses on the modifications to an already cleared predicate device (EasyMax MU SMBGS) and the testing done to ensure these modifications did not negatively impact safety or essential performance.
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Acceptance Criteria Mentioned (for specific modifications):
- Readability Test for Product Name Change: Flesch-Kincaid grade level $\leq$ 8.0 for all inserts.
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"Study that proves the device meets the acceptance criteria" (for modifications):
The document lists several "Verification and Validation activities" performed due to the addition of the Bluetooth dongle and software changes:- Safety Test: IEC 61010-1:2010; IEC61010-2-101:2002
- EMC Test: IEC 60601-1-2:2014; 61326-1:2001
- FCC test: FCC Part 15 Subpart B & C
- Human Factor Test: IEC 62366-1:2015
- Drop and Vibration Test: ISTA 2A: 2011; IEC60068-2-64: 2008
- Software Validation Test: IEC 62304:2006; FDA guidance Document "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices."
The document states that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission."
In summary, the provided text serves as a regulatory summary of modifications to a previously cleared device, asserting that necessary testing (including, but not detailed, performance similar to the predicate) has been conducted and documented in other reports to ensure substantial equivalence. It does not contain the detailed clinical or analytical performance study results themselves.
§ 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.