(25 days)
AutoSure Voice II Blood Glucose Monitoring System: The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Blood Glucose Test Strips: The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for selftesting by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Voice II blood glucose monitoring system consists of a meter and AutoSure test strips. It is used for testing of blood glucose by self-testers at home and for professional testers in healthcare facilities.
The provided document does not contain the level of detail required to fulfill all aspects of the request. Specifically, it is lacking information about the quantitative acceptance criteria, the specific study design for clinical testing, the sample sizes for the test set, the number and qualifications of experts, the adjudication method, details about a multi-reader multi-case study, the type of ground truth used for the test set, and how ground truth for the training set was established.
However, based on the limited information available in the 510(k) summary, here's what can be inferred and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It broadly claims "Results demonstrate substantial equivalence to the predicate device." for both non-clinical and clinical testing. For blood glucose monitoring systems seeking 510(k) clearance, the typical acceptance criteria for accuracy involve specific percentages of measurements falling within ±X% or ±Y mg/dL of a reference method. This document does not provide those specific numbers.
| Acceptance Criteria (Not explicitly stated, but typically expected for blood glucose monitors) | Reported Device Performance (Generalized adherence) |
|---|---|
| e.g., X% of results within ±Y mg/dL or ±Z% of reference (specific values not provided in document) | "Results demonstrate substantial equivalence to the predicate device." |
| e.g., Clinical Accuracy for healthcare professionals and lay users (specific values not provided) | "An accuracy study was performed with blood testing by healthcare professionals." and concluded "substantially equivalent." |
| Ease-of-use and user manual comprehension. | "A user study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual." and concluded "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The summary only mentions "An accuracy study was performed" and "A user study was conducted."
- Data Provenance: The document implies the data is likely prospective clinical data collected for the purpose of the 510(k) submission, as it describes "An accuracy study was performed with blood testing...". No country of origin for the clinical study data is specified beyond the submitter's location in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided document.
4. Adjudication method for the test set
Not specified in the provided document.
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 is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements. The "human readers" in this context would be users performing the blood glucose test, not interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "accuracy study" performed is a standalone assessment of the device's numerical output against a reference method. The device (meter and test strips) is an algorithm/system generating a quantitative glucose value. The study compared this quantitative output to a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy study would have been established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which is the standard for such device comparisons. While not explicitly named, this is the accepted "ground truth" for blood glucose monitor accuracy claims.
8. The sample size for the training set
Not applicable/Not specified. This device is not described as utilizing a machine learning algorithm that requires a distinct "training set" in the conventional sense. Its "algorithm" refers to the electrochemical principles and calculations for glucose measurement, which are established rather than "trained" on data for pattern recognition.
9. How the ground truth for the training set was established
Not applicable, as there's no mention of a machine learning training set. The underlying principles and calibration were established through engineering and analytical validation.
§ 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.