Search Results
Found 3 results
510(k) Data Aggregation
(242 days)
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001
The TheraSense, Inc., FreeStyle 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The TheraSense, Inc., FreeStyle Tracker Diabetes Management 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.
The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
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 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 (bee) 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 liguid crystal display (LCD).
Here's an analysis of the provided text regarding the acceptance criteria and study for the FreeStyle Blood Glucose Monitoring System:
The provided document, a Premarket Notification Labeling Modification for the FreeStyle Blood Glucose Monitoring System, is very brief and does not contain the detailed information requested about acceptance criteria and comprehensive study results. It primarily focuses on the labeling modification to include the palm as an alternative test site.
Therefore, many of the requested fields cannot be filled from the given text.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of accuracy or precision metrics for the blood glucose monitoring system itself. It only mentions a clinical study performed to support a labeling change.
| Acceptance Criteria (Not Explicitly Stated for Device Performance in Glucose Measurement) | Reported Device Performance (Regarding Equivalence of Rapid Glucose Change Sites) |
|---|---|
| Not specified in the provided text. Acceptance criteria for glucose measurement accuracy (e.g., ISO 15197 standards) are generally required for glucose monitoring systems, but are not detailed here. | Clinical study demonstrates that during times of rapid glucose change, palm and fingertip glucose values are the same. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions a "clinical study data," but does not provide details on:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin).
- Study design: It states "The clinical study data demonstrate... This study confirms results in several published reports...", which implies it was a prospective study conducted to gather new data to confirm existing literature, but does not explicitly state "prospective."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a blood glucose monitoring system, and the "ground truth" for glucose levels is typically established by a reference laboratory method, not by expert interpretation. The text does not describe the method for establishing reference glucose values.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used when subjective interpretations are involved (e.g., reading medical images). For quantitative measurements like blood glucose, adjudication of results is generally not performed in this manner.
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
Not applicable. This is a standalone medical device (blood glucose meter), not an AI-assisted diagnostic tool involving human readers interpreting outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device itself (the FreeStyle Blood Glucose Monitoring System) is a standalone measurement device. It provides quantitative glucose readings directly. The study mentioned focuses on comparing glucose values obtained from different body sites using this standalone device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" method used for the glucose measurements. For blood glucose meters, the ground truth is typically established by an accurate laboratory reference method (e.g., YSI analyzer). The study aimed to show equivalence between two measurement sites, rather than absolute accuracy against an external gold standard.
8. The sample size for the training set
Not applicable. This document describes a clinical study for a traditional medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model described here.
Ask a specific question about this device
(287 days)
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
Ask a specific question about this device
(157 days)
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
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."
Ask a specific question about this device
Page 1 of 1