(256 days)
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.
The Advance Micro-draw™ Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics 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 Advance Micro-draw™ Blood Glucose Test Strips.
The provided document is a 510(k) summary for the Advance Micro-draw™ Blood Glucose Monitoring System, seeking clearance for an expanded indication to include palm testing in addition to fingertip testing. It does not provide detailed acceptance criteria or a comprehensive study report with the level of detail requested for an AI/device performance study.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy percentages, bias limits) that the device must meet. It only states that "Linear regression statistics showed good correlation between fingertip and alternate site results."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (from "7. CLINICAL TESTING") |
|---|---|
| Not provided in the document | Linear regression statistics showed good correlation between fingertip and alternate site (palm) results. |
| Tested blood glucose values encompassed the 51-435 mg/dL glucose range. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: "Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight." A specific number of participants or samples is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It implies a prospective study as it describes "testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The "ground truth" in this context would likely be the fingertip blood glucose measurement, which is considered the standard for comparison.
- Number of experts: The document mentions "clinicians" obtained fingertip results, but does not specify the number or qualifications of these clinicians.
- Qualifications of experts: Not provided.
4. Adjudication method for the test set
- There is no information on any adjudication method. For a blood glucose meter, the "ground truth" or reference method is typically another validated glucose measurement method (e.g., a laboratory analyzer), and the device's readings are compared directly to that. Differences are usually handled statistically without a need for expert adjudication in the same way an imaging study might.
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
- No, this is not applicable. The device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation device that human readers would use. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this was effectively a standalone performance study. The Advance Micro-draw™ Blood Glucose Monitoring System is a device that provides a direct numerical output. The study compared the device's readings from the palm (new indication) against its readings from the fingertip (established method), both of which are "algorithm-only" outputs from the device itself. The primary objective was to show the equivalence of the device's performance at the alternate site.
7. The type of ground truth used
- The "ground truth" or reference method for the alternate site (palm) measurements was the fingertip blood glucose results obtained by clinicians. While not explicitly stated, clinical practice for blood glucose meter validation typically involves comparison to a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods) for the initial validation of the fingertip readings, and then the fingertip reading can serve as the "clinical ground truth" for comparing alternate sites. The document implies the fingertip results were the standard against which the palm results were compared.
8. The sample size for the training set
- This document describes a clinical validation study for an expanded indication. It does not provide information about a "training set" as it would for a machine learning model. Blood glucose meters are typically developed and calibrated in a different manner, involving engineering and chemistry, rather than machine learning training sets in the AI sense.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned or relevant to the traditional development of a blood glucose meter, no information is provided on how its "ground truth" was established.
§ 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.