(92 days)
The AutoSure Voice 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.
The AutoSure Voice Blood Glucose Test Strips are to be used with the AutoSure Voice Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice System is plasma-calibrated for easy comparison to lab result. The AutoSure Voice Blood Glucose Monitoring System is intended for self-testing by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Voice consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control
The provided text describes the 510(k) summary for the "AutoSure Voice Blood Glucose Monitoring System". However, it does not contain a detailed study report with acceptance criteria, sample sizes, ground truth establishment methods, or the performance data structured in table format as requested.
The document primarily focuses on:
- Device Description: AutoSure Voice consists of a meter, test strips, and control solutions.
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from fingertips, forearm, or palm, for monitoring diabetes. It includes voice functionality for visually impaired users. Indicated for lay use and clinical settings.
- Functional and Safety Testing: Mentions linearity testing (confirming no adverse effect of preset meter calibration code on accuracy or precision), verification of Lo/Hi display for out-of-range results, and software verification/validation.
- Conclusion: The device modification does not adversely affect performance and is substantially equivalent to the predicate device (GlucoSure Voice BGM System).
- FDA Determination Letter: Confirms substantial equivalence based on the provided information.
Therefore, I cannot fulfill most of the request based solely on the provided text, as the specific study details needed are absent.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in a quantitative manner in the provided text. The general statement is "linearity testing confirmed that the use of a preset meter calibration code did not have an adverse effect on accuracy or precision."
- Reported Device Performance: No specific quantitative performance data (e.g., accuracy, precision, bias values, agreement percentages) are provided in the text.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not mentioned. For blood glucose meters, the "ground truth" is typically a laboratory reference method (e.g., YSI glucose analyzer), not expert consensus.
4. Adjudication method for the test set
- Not applicable as the text does not describe an adjudication process for this type of device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, this type of study is not relevant for a blood glucose monitoring system, which is a standalone device for quantitative measurements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone system for measuring blood glucose. The "Functional and Safety Testing" section describes some performance characteristics (linearity, out-of-range detection, software verification), which would relate to its standalone performance, but no detailed study results are given.
7. The type of ground truth used
- While not explicitly stated, for blood glucose meters, the ground truth is universally established by a laboratory reference method (e.g., a YSI glucose analyzer) to which the device's results are compared for accuracy. The text mentions "plasma-calibrated for easy comparison to lab result," which indirectly references a laboratory standard.
8. The sample size for the training set
- Not mentioned. This device likely does not use a "training set" in the context of machine learning algorithms in the same way an AI-driven image analysis system would. Its "training" would involve calibration and validation during manufacturing.
9. How the ground truth for the training set was established
- Not mentioned. As above, the concept of a "training set" with ground truth in this context is likely different from AI/ML applications. The device's calibration would be established 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.