(249 days)
The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Alian Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth Align Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth BG5 wireless Smart Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth BG5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The AGS-1000I test strips are for use with the iHealth BG5 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth BG5L wireless Smart Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The AGS-1000I test strips are for use with the iHealth BG5L meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
The iHealth Align Gluco-Monitoring System consists of a blood glucose meter, test strips, iHealth Gluco-Smart App, sterile lancets, lancing device and AGS-1000I Control Solutions (Level I. Level II and Level III). The iHealth Align Gluco-Monitoring System cannot display test results and must be used with an iPhone or iPod touch via an 3.5 mm auxiliary jack.
The iHealth BG5 wireless Smart and iHealth BG5L wireless Smart Gluco-Monitoring Systems consist of the BG5 and BG5L wireless Smart blood glucose meters, respectively, AGS-10001 Test Strips , sterile lancets, lancing device and the iHealth control solutions control solutions. (Control solutions provided are for Level 1, II, and III). iHealth BG5L uses Bluetooth 4.0 wireless radio technology; while iHealth BG5 uses Bluetooth 3.0 wireless radio technology. The iHealth BG5 and BG5L meters can display the test results and the test results can also be transmitted to an iPhone, iPod touch or iPad through blue tooth.
iHealth Gluco-Smart App is iOS- based software for use with the iHealth Align Glucose meter (BG1), iHealth BG5 meter, and iHealth BG5L meter. When used with these meters, iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data.
Here's an analysis of the provided text, focusing on acceptance criteria and study details for the iHealth Gluco-Monitoring Systems:
The provided documents are a 510(k) premarket notification for the iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, and iHealth BG5L wireless Smart Gluco-Monitoring System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials typical of novel devices. Therefore, the "acceptance criteria" and "study" described are primarily focused on proving that the new devices perform comparably to the predicate device and meet relevant regulatory standards for glucose monitoring systems.
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state a table of "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, or accuracy (e.g., within X% of a reference standard for Z% of readings). Instead, the acceptance criteria are implicitly tied to the performance characteristics of the predicate device and general regulatory expectations for glucose monitoring systems.
The performance is primarily summarized by stating that the new devices share key characteristics with the predicate and that "Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device."
Here's an attempt to infer and present the information in a table format based on the textual evidence:
| Characteristic/Criterion (Inferred) | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate device: Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, forearm, upper arm, calf, or thigh; for self-testing by people with diabetes at home as an aid to monitor effectiveness of diabetes control; not for diagnosis, screening, or neonatal use. Alternative site testing only during steady states. |
| Enzyme | Same as predicate device: Glucose oxidase |
| Measuring Range | Same as predicate device: 20-600 mg/dL |
| Hematocrit Range | Same as predicate device: 20-60% |
| Connectivity to Meter (for App) | iHealth Align: Earphone jack (same as predicate); BG5/BG5L: Bluetooth/Bluetooth low energy (new/improved, but functionally equivalent) |
| Display | iHealth Align: Connects to Apple platform (same as predicate); BG5/BG5L: Same as predicate AND LED meter display (new/improved, but functionally equivalent) |
| Test Strip Calibration | Same as predicate device: QR code scan |
| Software Performance | "Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device." The submission claims these differences "do not raise any new questions of safety and effectiveness." This implies that the software's ability to display results accurately, manage data, and connect with the meters was found to be acceptable and comparable to the predicate's functionality. |
| Safety and Effectiveness | Demonstrated that "these small differences do not raise any new questions of safety and effectiveness." (Implies meeting the same safety and effectiveness profile as the predicate). This is a core regulatory acceptance criterion for 510(k) submissions. |
2. Sample Size for the Test Set and Data Provenance
The document mentions "user study" but does not specify the sample size for any clinical or test set. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a glucose monitoring system, user studies often involve a diverse cohort to assess performance across various glucose levels and user demographics. However, these specific details are absent from the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. For glucose monitoring systems, "ground truth" is typically established by comparing the device's readings against a highly accurate laboratory reference method (e.g., YSI glucose analyzer), rather than expert adjudication of images or clinical reports. The general term "user study" is used, which implies participants used the device and its performance was evaluated against a reference.
4. Adjudication Method for the Test Set
As the document does not describe a process involving experts to establish ground truth for a test set in the traditional sense, there is no mention of an adjudication method like 2+1 or 3+1. Performance is likely assessed against a laboratory reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. This type of study is more common in diagnostic imaging or clinical decision support AI devices where human interpretation is a key component. The iHealth devices are standalone glucose meters; while an app is involved, it primarily acts as a display and data management tool, not an AI for interpretation.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The core performance of the glucose measurement algorithm itself (i.e., the meter and test strip system) is evaluated. The 510(k) process for glucose meters typically requires studies demonstrating the accuracy of the device's readings against a laboratory reference method. Although the document uses the broad term "performance summary," this usually entails standalone accuracy data. The phrase "Software validation and user study has been performed to establish the performance, the functionality and the reliability characteristics of the new device" suggests that the device's ability to accurately measure glucose without a human in the interpretative loop was a key part of the validation.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for glucose monitoring systems, the ground truth is almost universally established using a laboratory reference method (e.g., a YSI glucose analyzer) that is considered the gold standard for glucose measurement.
8. Sample Size for the Training Set
The document does not mention a "training set" sample size. This is expected because the iHealth Gluco-Monitoring Systems, as described, do not appear to be AI/Machine Learning devices that require a "training set" in the context of learning algorithms. They are likely electrochemical biosensors with pre-defined algorithms for glucose calculation. The app primarily handles data display and management.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth was established. The device likely relies on established physical and chemical principles of glucose measurement rather than a trained AI model.
§ 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.