(157 days)
The TheraSense FreeStyle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.
The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.
The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.
When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).
The provided document focuses on the FreeStyle™ Blood Glucose Monitoring System by TheraSense Inc. and details the submission for 510(k) clearance, claiming substantial equivalence to predicate devices. It describes the device's function and intended use, along with a summary of performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific numerical acceptance criteria (e.g., specific accuracy percentages, bias limits, or precision requirements) for the FreeStyle system. Instead, it refers to fulfilling general performance requirements and clinical acceptable accuracy based on a recognized method.
However, the reported device performance indicates it met these implicit criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance requirements outlined in FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology." | "Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use." |
| "The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements." | |
| Clinical acceptable accuracy (likely referring to the Clarke Error Grid Analysis) | "When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy." |
| Equivalence to predicate device (FastTake) | "The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake." |
| Performance equivalence between lay user and trained technicians | "The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician." |
| Correlation with laboratory reference method | "The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method." |
Note: The specific numerical targets for "clinical acceptable accuracy" or "performance requirements" are not detailed in this submission summary. These would typically be found in the full study report or the FDA guidance referenced.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "A multi-center controlled clinical study was conducted," but it does not specify the sample size (number of patients or samples) used for this clinical study.
- Data Provenance: The study was a "multi-center controlled clinical study," implying prospective data collection across multiple sites. The document does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the clinical study was established by a "standard laboratory test for measuring blood glucose."
- Number of Experts: The document does not specify the number of experts (e.g., laboratory technicians, clinical chemists) involved in performing or interpreting the laboratory reference method.
- Qualifications of Experts: The document implicitly suggests the reference method was performed by "experienced technicians" or qualified laboratory personnel, as it refers to a "standard laboratory test," but does not explicitly state their qualifications (e.g., "clinical pathologist with 15 years of experience").
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical study directly compared FreeStyle and the predicate device results to a "standard laboratory test" for ground truth.
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
This is not applicable to this device. The FreeStyle Blood Glucose Monitoring System is an in vitro diagnostic device for quantitative glucose measurement, not an AI-assisted diagnostic imaging device requiring human reader interpretation or MRMC studies. The "human readers" in this context are lay users and trained technicians operating the device, and the comparison is between their use of the FreeStyle system versus a laboratory method and a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable in the AI sense. The FreeStyle system is a standalone device in that it provides a direct glucose reading from a blood sample without human interpretation of complex images or data beyond reading the displayed number. The performance study evaluated the device's accuracy in producing this reading, both in the hands of lay users and trained technicians, implying testing of the device as a standalone system.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was a "standard laboratory test for measuring blood glucose." This is a gold standard reference method for blood glucose concentration.
8. The Sample Size for the Training Set
The document does not mention a separate training set or its sample size. This is common for traditional medical devices where performance is typically established through analytical and clinical validation studies, rather than machine learning models that require distinct training and test sets.
9. How the Ground Truth for the Training Set was Established
Since a separate "training set" in the machine learning sense is not indicated or discussed, the method for establishing its ground truth is not applicable to this document. The ground truth for the overall performance evaluation was established by a "standard laboratory test for measuring blood glucose."
§ 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.