(83 days)
The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER ELITE System consists of an electrochemical method-based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
Here's an analysis of the provided text regarding the GLUCOMETER ELITE® Blood Glucose Meter, focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a formal table format. However, the "Technological Characteristics" section implies certain performance goals. The "Assessment of Performance" and "Conclusion" sections indicate that the device was evaluated for equivalence to a predicate device.
Based on the text, we can infer the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Time to obtain a result: Reduced from 60 seconds | Time to obtain a result: Reduced to 30 seconds |
| Operating range: Expanded from 40-500 mg/dL | Operating range: Expanded to 20-600 mg/dL |
| ROM capacity: Increased from retaining 10 results | ROM capacity: Increased to retaining 20 results |
| Improvements in calibration and temperature correction | Improvements in calibration and temperature correction implemented |
| Equivalence to the predicate device (GLUCOMETER ELITE® Blood Glucose Meter manufactured by Kyoto Daiichi Kagaku Co., Ltd) in the hands of diabetics and healthcare professionals | "The results of the evaluation...demonstrate that the modified meter is equivalent in performance to the predicate device and suitable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not explicitly state the specific number of participants (diabetics and healthcare professionals) or the number of blood glucose readings taken. It only mentions that the evaluation was "conducted at three clinical sites."
- Data Provenance: The study was conducted at "three clinical sites," implying a prospective clinical evaluation. The country of origin of the data is not specified, but the submitter is Bayer Corporation, Business Group Diagnostics, in Elkhart, IN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text does not provide any information about the number of experts used to establish ground truth or their qualifications. For blood glucose meters, the "ground truth" often refers to reference measurements obtained using a laboratory analyzer (e.g., a YSI analyzer), rather than expert adjudication of interpretations. The text does not specify how the reference measurements were obtained.
4. Adjudication Method for the Test Set
The text does not describe any adjudication method. As mentioned above, for blood glucose meters, the primary comparison is usually against a highly accurate laboratory reference method, not expert consensus on interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and not performed in this context. This device is a blood glucose meter intended for direct measurement, not for interpretation by human readers. The purpose of the study was to demonstrate the device's accuracy and equivalence to a predicate device, not, for example, how an AI would improve a radiologist's performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is inherently a "standalone" device in its function (the meter provides a direct reading). The study evaluated the performance of the modified GLUCOMETER ELITE® Blood Glucose Meter itself. The phrase "in the hands of diabetics and healthcare professionals" suggests a real-world use context, but the core performance being assessed is the meter's ability to accurately measure blood glucose. There isn't a separate "algorithm only" component vs. a human-in-the-loop component in the way that might apply to an AI diagnostic assistant.
7. Type of Ground Truth Used
The text does not explicitly state the type of ground truth used. However, for blood glucose meters, the ground truth is typically established by comparison to a laboratory reference method, such as a YSI glucose analyzer, which is considered the gold standard for blood glucose measurement.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here because this is a physical medical device (blood glucose meter) with embedded electronics and algorithms for measurement, not a machine learning or AI model that undergoes explicit training. The device's internal algorithms (e.g., for calibration and temperature correction) are developed and refined through engineering and testing, not by training on a "dataset."
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a training set is not applicable. The development and refinement of the meter's internal measurement and correction algorithms would have been based on extensive sensor characterization, chemical reaction kinetics, and laboratory testing against reference glucose solutions and blood samples across a range of conditions, using laboratory reference methods to establish the "ground truth" for those developmental phases. The text does not provide these details.
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Bayer Corporation, Business Group Diagnostics GLUCOMETER ELITE® Blood Glucose Meter 510(k) Safety and Effectiveness Summary Page 1 of 2
FEB 10 1997
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | November 18, 1996 | |
|---|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics | |
| Address: | 1884 Miles Avenue, P. O. Box 70Elkhart, IN 46515(219) 262-6929 | |
| Contact: | Rosanne M. Savol, R.A.C.Manager, Regulatory Affairs | |
| Device: | Trade/Proprietary Name: GLUCOMETER ELITE® Blood Glucose MeterCommon/Usual Name: Blood Glucose MeterDocument Control Number: K96 ______ | |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 CGA (Glucose Oxidase, Glucose) | |
| Predicate Device: | GLUCOMETER ELITE® Blood Glucose MeterManufactured by Kyoto Daiichi Kagaku Co., Ltd: of Kyoto,Japan | |
| Device Description: | The GLUCOMETER ELITE System consists of anelectrochemical method-based meter and dry reagent sensors (teststrips) designed for testing glucose by persons with diabetes or byhealthcare professionals in the home or in healthcare facilities. | |
| Intended Use: | The GLUCOMETER ELITE Blood Glucose Meter is for theSelf-Monitoring of Blood Glucose as an adjunct to the care ofpersons with diabetes. * |
* "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99.
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Bayer Corporation, Business Group Diagnostics
GLUCOMETER ELITE® Blood Glucose Meter
| Technological Characteristics: | The electronics of the GLUCOMETER ELITE Blood Glucose Meter have been modified to reduce the time for obtaining a result from 60 to 30 seconds. The operating range has been expanded from 40 - 500 mg/dL to 20 - 600 mg/dL. The capacity of the read only memory (ROM) has been increased from retaining 10 results to 20 and improvements in calibration and temperature correction have been implemented. In addition, cosmetic changes to the case give the meter a new appearance and the test slot has been moved from the left side to the top of the meter. |
|---|---|
| Assessment of Performance: | An evaluation of the modified GLUCOMETER ELITE Blood Glucose Meter was conducted at three clinical sites to demonstrate the equivalence of the modified meter to the currently used GLUCOMETER ELITE Blood Glucose Meter, the predicate device, in the hands of diabetics and healthcare professionals. |
| Conclusion: | The results of the evaluation of the GLUCOMETER ELITE Blood Glucose Meter demonstrate that the modified meter is equivalent in performance to the predicate device and suitable for its intended use. |
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§ 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.