(267 days)
AG-608, AG-610 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger only. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.
AG-608, AG-610 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, lancets, lancing device and the control solutions (available if user requests). The AG-608, AG-610 blood Glucose Monitoring system is 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 are used to test the performance of the device.
The provided 510(k) summary for the AG-608 and AG-610 Blood Glucose Monitoring Systems states that the devices conform to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. This standard specifies the acceptance criteria for blood glucose monitoring systems.
However, the summary does not explicitly list the specific acceptance criteria within ISO 15197, nor does it present a detailed table of the reported device performance against those criteria. It only generally states that "Non-clinical test and the clinical test are done according to the above standard."
Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and reported device performance cannot be fully constructed. The other requested information is also largely absent from this specific summary.
Here's a breakdown of what can and cannot be extracted from the provided text, addressing each point of your request:
1. A table of acceptance criteria and the reported device performance
As mentioned above, the document states conformity to ISO 15197 but does not provide a specific table of acceptance criteria from that standard or the device's performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary.
- Retrospective or Prospective: Not specified in the provided summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified in the provided summary. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory instrument (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not typically by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/specified. Adjudication methods are usually relevant for subjective interpretations (e.g., radiology reads), not for quantitative measurements like blood glucose, where a reference method is typically used to establish ground truth.
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 device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is implicitly a standalone performance study. The device measures blood glucose levels without human interpretation of the measurement; the user reads the displayed numerical result. The performance data would be for the algorithm/device itself compared to a reference standard. However, the specific data is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Implicitly, the ground truth for blood glucose monitoring systems is established using a reference laboratory method (e.g., a highly accurate glucose analyzer) that is traceable to an internationally recognized standard. The document mentions "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]," and ISO 15197 requires comparison to a laboratory reference method.
8. The sample size for the training set
Not specified in the provided summary. For blood glucose meters, the "training set" doesn't refer to machine learning model training but rather to the data and calibration used during the device's development and manufacturing. This information is not typically detailed in 510(k) summaries.
9. How the ground truth for the training set was established
Not specified in the provided summary. Similar to the test set, it would be established using a reference laboratory method for glucose measurement.
§ 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.