(13 days)
The FreeStyle™ Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle™ Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.
The provided document describes a 510(k) premarket notification for the FreeStyle™ Lite Blood Glucose Monitoring System. It states that the device was studied in a laboratory and the results demonstrated substantial equivalence to a predicate device (FreeStyle Freedom™ Blood Glucose Monitoring System, K051839). However, it lacks detailed quantitative acceptance criteria and specific study results.
Here's an attempt to answer your questions based on the available information, noting where details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific reported device performance values. It generally claims the device is "acceptable and comparable" and achieved "substantial equivalence" to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document states that the performance was "studied in the laboratory." It does not provide information on the sample size used for the test set (number of blood samples, number of participants), data provenance (country of origin), or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for blood glucose measurements is typically established by laboratory reference methods, not subjective adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
An MRMC study is not relevant for a blood glucose monitoring system, which provides a quantitative measurement rather than requiring interpretation by multiple readers. The document does not describe such a study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
A blood glucose monitoring system inherently performs as a "standalone" device in the sense that the algorithm processes the blood sample and displays a glucose value without human intervention in the measurement process itself. The document describes laboratory testing of the system, which represents its standalone performance.
7. The Type of Ground Truth Used
While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer or equivalent). This method provides highly accurate and precise glucose measurements for comparison. The document mentions "laboratory testing," which implies comparison against such a reference.
8. The Sample Size for the Training Set
The document does not provide information about a training set size. For a biosensor of this type, the "training" (calibration) is often built into the manufacturing process of the test strips and meter, rather than requiring a separate "training set" like in machine learning models. If any internal calibration or validation involved a dataset, it is not disclosed here.
9. How the Ground Truth for the Training Set was Established
As no training set is described in the context of machine learning, this question is not directly applicable. If there were internal calibration processes, the ground truth for those would typically be established using highly accurate laboratory 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.