(118 days)
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
The Assure® Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by persons with diabetes to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure® Pro Test Strips.
The provided 510(k) summary for the Assure® Pro Blood Glucose Monitoring System describes a clinical study to demonstrate its accuracy. However, specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text. The summary generally claims "good correlation" without quantifying it against pre-defined thresholds.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "good correlation" but doesn't provide numerical thresholds for accuracy (e.g., % within +/- X mg/dL, or accuracy metrics against a reference standard). | Linear regression statistics showed "good correlation between participant, clinician and reference results." Tested blood glucose values encompassed the 61-383 mg/dL glucose range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "participants with diabetes" but does not quantify the number of individuals or the number of samples collected.
- Data Provenance: The study was a prospective clinical testing, comparing results obtained by participants with diabetes against clinician results and reference methods. The country of origin for the data is not specified, but the submission is from Hypoguard USA, Inc. in Minneapolis, MN, USA, suggesting a US-based study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document refers to "clinician results" as part of the comparison. It does not specify the number of clinicians involved or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of a blood glucose monitor, these would likely be healthcare professionals, potentially nurses, phlebotomists, or laboratory technicians who are trained in blood drawing and glucose measurement.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- The document describes comparing results among "participants with diabetes," "clinician results," and "reference method results." This implies a comparison against a gold standard (reference method) and potentially other professional measurements. However, it does not describe an adjudication method in the sense of resolving discrepancies between human readers or experts (e.g., 2+1, 3+1). The "reference method" itself acts as the de facto "ground truth" against which all other measurements are compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context typically understood for AI/imaging devices (i.e., assessing human performance with vs. without AI assistance). This study focuses on the accuracy of a standalone device (blood glucose monitor) compared to reference methods and clinician measurements.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Accuracy/method correlation testing" directly evaluated the performance of the Assure® Pro Blood Glucose Monitoring System itself by comparing its readings to a recognized reference method and clinician results. This is a direct measure of the algorithm/device's accuracy.
7. Type of Ground Truth Used
- The type of ground truth used was a reference method. For blood glucose monitoring systems, this typically involves a laboratory-based, highly accurate method (e.g., using a YSI glucose analyzer or a similar clinical chemistry analyzer) that is considered the gold standard for glucose measurement. The document states "reference method results."
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This k-summary describes the device validation (clinical testing) to support substantial equivalence, not the development or training of an algorithm in the modern AI sense. Blood glucose meters do not typically involve "training sets" in the same way machine learning models do. Their calibration is usually established during manufacturing and validated through rigorous testing.
9. How Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable based on the provided document. The device operates based on electrochemical principles, and its internal calibration would be set during manufacturing and validated through testing, not through a "training set" in the sense of supervised learning.
§ 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.