(281 days)
The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application. The iHealth Wireless 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 Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth Wireless 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 Wireless Cluco-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 wireless Smart Gluco-Monitoring System(BG5) consist of blood qlucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
In order to use theiHealth wireless Smart Gluco-Monitoring System(BG5), a compatible Android or iOS mobile device with the necessary mobile application installed is required.
The provided text describes a glucose monitoring system, not an AI device. As such, the typical acceptance criteria and study elements associated with AI are not directly applicable.
However, I can extract information related to the performance criteria and validation study for the iHealth Wireless Smart Gluco-Monitoring System (BG5) as presented in the 510(k) summary. This device is a blood glucose meter, and its performance is assessed against accuracy standards for glucose measurements.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a table format with "reported device performance." However, it implies that the device meets the performance of its predicate device, as claimed in section 8.0. For glucose meters, the typical acceptance criteria are established by standards like ISO 15197 (Accuracy requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus). While these specific ISO criteria are not directly listed as "acceptance criteria" here, the declaration of "substantial equivalence" implies adherence to such recognized performance standards.
The document states:
- Measurement Range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L)
- Test Time: 5 seconds
- Sample Volume: Minimum 0.7 microliter
- Hematocrit Range: 20-60%
The comparison table (Section 7.0) indicates that the new device has the same characteristics as the predicate device (K123935) for these performance parameters, implying it meets the same performance as the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (New Device) |
|---|---|---|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from AST and finger | Capillary whole blood from AST and finger |
| Hematocrit Range | 20-60% | 20-60% |
| Operating Temp. | 10℃~35℃ (50°-95°F) | 10℃~35℃ (50°-95°F) |
| Measurement Range | 20mg/dL-600mg/dL | 20mg/dL-600mg/dL |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Test Time | 5 second | 5 second |
The key statement regarding meeting criteria is in Section 8.0: "the test in this submission provides demonstration that these small differences [connect to Android] do not raise any new questions of safety and effectiveness." This implies that the device's accuracy and performance are considered equivalent to the predicate, which would have met its own set of performance criteria, likely aligning with ISO 15197 for glucose meters.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for performance testing (e.g., number of subjects, number of blood samples). It also doesn't specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "the test in this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. For glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert interpretation, so the concept of experts establishing ground truth in this context is less relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is for a glucose meter and not an AI or imaging device requiring human expert adjudication.
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, as this is a standalone glucose meter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the device itself is a standalone glucose monitoring system. Its performance is evaluated on its ability to accurately measure glucose levels independent of human interpretation or AI assistance. The output is a numerical glucose reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a glucose meter, the ground truth is established by comparison to a laboratory reference method, typically a YSI glucose analyzer, which is considered highly accurate for quantitative glucose measurement in blood. This is standard for glucose meter validation, though not explicitly detailed in this summary.
8. The sample size for the training set:
Not applicable. This device is not an AI model requiring a "training set." It's a hardware medical device with electrochemical sensing technology.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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.