(147 days)
The AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Viro 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000 Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Meter. 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.
The AP-1000 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 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.
MAJOR Level I/Level II Control Solutions are for use with the AP-1000 meter and AP-1000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Based on an electrochemical biosensor technology and the principle of capillary action, AP-1000 Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
The provided text describes the AP-1000 Blood Glucose Monitoring System and mentions pre-clinical and clinical data without detailing the specifics of the study, acceptance criteria, or performance against specific metrics. Therefore, a comprehensive answer to all points of your request cannot be fully extracted from the provided document.
However, based on the information available, here's what can be gathered regarding the study and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state the acceptance criteria for specific performance metrics (e.g., accuracy percentages within certain glucose ranges) or fully report the device's performance against such criteria. It only indicates that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." This implies that the study was conducted to meet the requirements outlined in the FDA guidance for in vitro diagnostic test systems, but the specific numerical acceptance criteria and a table of reported performance against these criteria are not included in this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention an MRMC comparative effectiveness study or any effect size of AI assistance on human readers, as the device is a standalone blood glucose monitoring system and not an AI-assisted diagnostic tool for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The AP-1000 Blood Glucose Monitoring System is a standalone device intended for quantitative measurement of glucose. Its performance would inherently be evaluated in a standalone manner (algorithm/device only) without a "human-in-the-loop" as it's a direct measurement device rather than an interpretive aid. The document implies a standalone evaluation was performed by stating "Pre-clinical and clinical data are employed," but details are missing.
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the "ground truth" for accuracy studies would typically be established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer) known for their high accuracy. The document does not explicitly state the specific type of ground truth used but it would be expected to be a laboratory reference method.
8. The Sample Size for the Training Set
The document does not specify any training set sample size. For a blood glucose monitoring system based on electrochemical biosensor technology, the development would involve calibration and optimization using blood samples, but these are generally not referred to as "training sets" in the same way as machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable as a distinct "training set" in the context of machine learning is not mentioned or relevant for this type of device. The calibration and development would have been based on comparison to laboratory reference methods.
In summary, while the document indicates that pre-clinical and clinical data were used to demonstrate safety and effectiveness in accordance with FDA guidance, it lacks the detailed information requested regarding specific acceptance criteria, study sizes, ground truth establishment, and expert involvement.
§ 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.