(610 days)
The Joinsoon® EON L Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.
The Joinsoon® EON L Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinson® EON L Glucose Monitoring System should not be used for the diagnosis of circening of diabetes or for neonatal use.
The Joinsoon® EON L Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Joinsoon® Single Strips are for use with the Joinsoon® EON L Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips.
The Joinsoon® Control Solution is for use with the Joinsoon® HON L Glucose Meter and Joinsoon® Single Strips as a quality control check to verify that the meter and test strips are working together properly, and that the test is performing correctly.
The Joinsoon® EON LS Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.
The Joinsoon® EON LS Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinsoon® EON LS Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Joinsoon® EON LS Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Joinsoon® Snap Strips are for use with the Joinsoon® EON LS Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips.
The Joinsoon® Control Solution is for use with the Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
The Joinsoon® EON LS Glucose Monitoring system consists of: a Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips. The Joinsoon® EON L Glucose Monitoring system consists of: a Joinsoon® EON L Glucose Meter and Joinsoon® Single Strips. Both systems utilize an electrochemical – method based meter and dry reagent biosensor (test strip) for blood glucose testing. The electron accumulates on the electrode when glucose reacts with the reagent on the electrode. A current can be detected by the Joinsoon® EON LS and EON L glucose meters when a constant voltage is applied across the electrodes. The current will be converted into glucose concentration by an embedded transfer function in the meter. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The Joinsoon® Snap Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips. The Joinsoon® Snap Strip has 10 individual test sections which can be used one at a time with the Joinsoon® EON LS Glucose Meter. Each test section has its own Reaction Zone with the Enzyme at one end, and contact pads at the other end.
The Single Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips.
The Joinsoon® EON L Glucose Monitoring system is sold with the following components: Joinsoon® EON L Glucose Meter, Joinsoon® Single Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case.
The Joinsoon® EON LS Glucose Monitoring system is sold with the following components: Joinsoon® EON LS Glucose Meter, Joinsoon® Snap Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case.
The provided text describes the Joinsoon® EON L and EON LS Glucose Monitoring Systems and their substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the accuracy and user studies "met the acceptance criteria" but does not explicitly list the acceptance criteria themselves during the performance summary. It only states that "All of the evaluated performances met the predetermined acceptance criteria set in the study protocol." Therefore, a table with specific criteria and performance values cannot be fully constructed from the provided text.
However, the text mentions several non-clinical tests that presumably have their own acceptance criteria, but these are not explicitly stated in this summary for the reader to review. These tests are:
- Electromagnetic Compatibility/ESD (IEC 61326-1:2005, IEC 61326-2-6:2005, IEC 60601-1-2:2007)
- Emission (CISPR 11:2009+A1:2010 (Class B))
- Immunity (IEC 61000-4-2:2008; IEC 61000-4-3:2010; IEC 61000-4-6:2008; IEC 61000-4-8:2009)
- Linearity (CLSI EP6-A)
- Interference (CLSI EP7-A2)
- Traceability (ISO 17511:2003)
- Stability Test (CLSI EP25-A)
- Precision (CLSI EP5-A2)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Accuracy Study (Clinical Test):
- Sample Size: 150 participants.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
- User Study (Clinical Test):
- Sample Size: 150 users.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
- Non-Clinical Tests: No specific sample sizes for these are outlined, as they refer to bench testing with standards rather than human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. It states that the accuracy study compared the glucose values from the device, the predicate device, and "a lab instrument." The "lab instrument" is implied to be the ground truth reference, but no details about its operation or expert involvement are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for the test set.
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
This section is not applicable to the provided document. The device is a glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable in the AI sense. However, the "accuracy study" can be considered a standalone performance evaluation of the device itself (algorithm + hardware) against a reference, where the device directly provides a quantitative glucose measurement without human interpretation of raw data. The "user study" then assesses performance with human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy study, the ground truth was established by a "lab instrument" that provided "whole blood (plasma equivalent) glucose values." This suggests a highly precise and accurate laboratory reference method, such as a YSI glucose analyzer, which is a common ground truth for glucose meters.
8. The sample size for the training set
The document does not provide information about a training set. This is typical for glucose monitoring systems where the calibration (which could be considered analogous to "training") is often performed during manufacturing and validated through a series of robust studies as described. The document refers to "an embedded transfer function in the meter" to convert current to glucose concentration, implying a pre-calibrated system.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned in the context of machine learning, the question of how its ground truth was established is not applicable here. The device's calibration or "transfer function" would have been established using reference methods, but the details are not provided in this summary.
§ 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.