(370 days)
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose 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 iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and foream testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly).
BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter, BGStar Test Strips, BGStar Control Solution.
The iBGStar Diabetes Manager Application is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Here's a breakdown of the acceptance criteria and supporting study details for the AgaMatrix iBGStar Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a numerical format that would commonly be seen with diagnostic performance metrics (e.g., sensitivity, specificity, accuracy within a certain percentage). Instead, it focuses on demonstrating substantial equivalence to predicate devices.
However, the "Assessment of Performance" section implicitly identifies the core acceptance criteria as demonstrating ease of operating and performance equivalent to predicate devices for both the iBGStar Blood Glucose Monitoring System (BGMS) and the iBGStar Diabetes Manager Application.
| Acceptance Criteria (Implicit from Submission) | Reported Device Performance (as stated in the document) |
|---|---|
| Ease of operating the iBGStar BGMS | Demonstrated ease of operating the iBGStar BGMS |
| Ease of operating the iBGStar Diabetes Manager Application | Demonstrated ease of operating the iBGStar Diabetes Manager Application |
| Performance equivalence to predicate devices for iBGStar BGMS | Clinical evaluations demonstrate the iBGStar BGMS is equivalent in performance to the predicate devices. |
| Performance equivalence to predicate devices for iBGStar Diabetes Manager Application | Clinical evaluations demonstrate the iBGStar Diabetes Manager app is equivalent in performance to the predicate devices. |
| Suitability for intended use | Demonstrated suitable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set in a clinical study. It generally states a "clinical setting by person with diabetes." It does not provide information on the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically come from a laboratory reference method, not expert consensus.
4. Adjudication Method for the Test Set
This information is not provided in the document, as the "ground truth" for a blood glucose device would not typically involve expert adjudication in the same way as, for instance, imaging interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This submission is for a blood glucose meter and accompanying software, not an interpretive AI system for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary device (iBGStar Blood Glucose Monitoring System) is a standalone device that measures blood glucose. The iBGStar Diabetes Manager Application is software that processes and displays data from the blood glucose meter. The "Assessment of Performance" states that "An evaluation of the iBGStar BGMS and iBGStar Diabetes Manager Application were studied in house and in a clinical setting," implying that the performance of the device (BGMS) and the application (Diabetes Manager) were evaluated. The BGMS itself performs "algorithm only" measurements.
7. The Type of Ground Truth Used
While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance evaluation is almost always established through comparison to a laboratory reference method (e.g., a YSI analyzer) for blood glucose measurement. The document implies this by focusing on "quantitative measurement of blood glucose levels."
8. The Sample Size for the Training Set
This information is not provided. Blood glucose meters typically do not use a "training set" in the same machine learning sense, but undergo extensive calibration and verification during manufacturing. If an algorithm is involved in the measurement, its development would involve data, but it's not described here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As mentioned above, typical blood glucose meter development involves calibration against reference methods.
§ 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.