(242 days)
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.
§ 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.