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510(k) Data Aggregation
(36 days)
The EasyPlus mini R9N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The EasyPlus mini R9N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The EasyPlus mini R9N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
EasyPlus mini R9N Glucose Control Solutions: For use with the EasyPlus mini R9N meter and EasyPlus mini R9N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
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Here's an analysis of the provided text, focusing on Acceptance Criteria and the Study that proves the device meets those criteria, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (FDA 510(k) summary) does not explicitly state the acceptance criteria in a table format with corresponding reported device performance for a study. Instead, it refers to the device being substantially equivalent to legally marketed predicate devices. This implies that the device's performance is expected to be comparable to established devices in the market that have already met certain performance standards.
The indications for use describe the intended performance capabilities, but not specific numerical acceptance criteria. For example, it measures "quantitative measurement of glucose" and acts as "an aid to monitor the effectiveness of diabetes control."
To provide a hypothetical table based on typical glucose meter requirements, and assuming the device met these implicit standards for substantial equivalence:
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical, based on ISO 15197 or similar) | Reported Device Performance (Implied from Substantial Equivalence and typical device data in 510(k)s) |
|---|---|---|
| Accuracy (Against Lab Reference) | 95% of results within ±15 mg/dL or ±15% of reference for glucose < 100 mg/dL and ≥ 100 mg/dL respectively. | Implied to meet or exceed, resulting in substantial equivalence |
| Precision/Repeatability (SD or CV) | CV < 5% or SD < 5 mg/dL across measurement range. | Implied to meet or exceed, resulting in substantial equivalence |
| User Performance/Ease of Use | Successful operation by lay users; low error rates. | Implied to be comparable to predicate devices. |
| Interfering Substances | No significant interference from common substances. | Implied to be comparable to predicate devices. |
| Hematocrit Range | Accurate measurements across specified hematocrit range. | Implied to be comparable to predicate devices. |
Note: The provided document is a 510(k) clearance letter, which typically summarizes the FDA's decision based on reviewed data. It does not generally contain the detailed study results or explicit acceptance criteria itself. These details would be found in the manufacturer's 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain any information regarding the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in the detailed study reports submitted as part of the 510(k) application, not in the FDA's clearance letter.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. For glucose meters, ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel, rather than clinical experts adjudicating images.
4. Adjudication Method
The document does not mention any adjudication method. For glucose meters, the "ground truth" for blood glucose levels is usually determined by a highly accurate laboratory reference instrument, not through multi-expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable: The device discussed is a "Self Monitoring Blood Glucose System" (EasyPlus mini R9N SMBG system), which is an in-vitro diagnostic device for measuring glucose directly. It is not an imaging device or an AI system that assists human readers in interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance would not be relevant or performed for this type of device.
6. Standalone Performance Study (Algorithm Only)
Not Applicable: This device is a blood glucose meter, not an algorithm. Its performance is evaluated as a complete system (meter + strips) in measuring glucose levels directly from blood samples. While it contains internal algorithms for calculation and display, "standalone" algorithm performance in the way it's understood for AI systems (i.e., algorithm only without human-in-the-loop) doesn't apply directly. The entire system's (meter + strip) accuracy and precision are assessed.
7. Type of Ground Truth Used
Based on the nature of a blood glucose monitoring system, the ground truth would typically be established by:
- Reference laboratory method: Measurements from a highly accurate and precise laboratory instrument (e.g., YSI glucose analyzer, hexokinase method) on the same blood samples.
- Comparison to predicate devices: Performance compared against legally marketed predicate glucose meters.
The document does not explicitly state the type of ground truth used, but this is the standard for such devices.
8. Sample Size for the Training Set
Not Applicable: Blood glucose meters are not typically "trained" in the machine learning sense using a training set of data. Their calibration and performance are based on chemical and electrochemical principles, manufacturing processes, and quality control. There isn't a "training set" in the context of an AI algorithm learning from data.
9. How the Ground Truth for the Training Set was Established
Not Applicable: As explained above, there is no "training set" or "ground truth for a training set" in the context of a blood glucose meter's primary function.
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