Search Results

The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared.

The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.

The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The EosHealth, Inc. In Touch® BGMS, is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:

• In Touch® Blood Glucose Meter (In Touch® meter)
• In Touch® Blood Glucose Test Strips ●
• In Touch® Lancing Device ●
• In Touch® Lancets ●
• In Touch® Level 1 Control Solution
• In Touch® Level 2 Control Solution
• AC Adapter (wall charger) and USB Charger
• Carrying Case
• . In Touch® Data Management System (optional accessory to the In Touch® BGMS)

The In Touch® meter is an Over-The-Counter (OTC), handheld device that along with the primary components of the system, monitors glucose in the blood to help with the management and treatment of diabetes. The In Touch® meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs, and a pedometer.

The test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips.

These blood glucose levels are displayed on the screen and stored in In Touch® meter's memory. In addition to the immediate read-out on In Touch® meter's display, the readings can also be transmitted securely over the GSM cellular network to a secure server. The use on the GMS connection also provides the ability for direct feedback from the server to the In Touch® meter.

Here's a breakdown of the acceptance criteria and study information for the In Touch Blood Glucose Monitoring System, based on the provided document:

Acceptance Criteria and Device Performance

Note: The document provides additional granular data for "Within ± 5%" and "Within ± 5 mg/dL" which are also met but ±15% and ±10mg/dL are the primary acceptance criteria for regulatory clearance.

Study Details

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size:
  • For Glucose Concentration ≥75 mg/dL: 93 capillary whole blood samples from fingertip.
  • For Glucose Concentration <75 mg/dL: 9 capillary whole blood samples from fingertip.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "lay user accuracy and performance" study, suggesting participants were likely "lay consumers" relevant to the target market (implied US, given FDA submission). The study appears to be prospective as it was conducted "as part of demonstrating safety and effectiveness" for this specific device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The ground truth was established using a YSI reference standard (YSI STAT standard reference) and/or mass spectrometry reference standard. These are laboratory-grade instruments, not human experts. The document does not mention human experts establishing ground truth for the quantitative glucose measurements.

4. Adjudication method for the test set:

• Since the ground truth was established by laboratory reference methods (YSI/mass spectrometry) and not by human experts making subjective diagnoses, there was no adjudication method between experts. The device readings were compared directly to the objective reference standard.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, which directly measures glucose levels. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance accuracy study was done. The "Accuracy Evaluation (non-user)" section describes a study where the In Touch® meter was evaluated for accuracy using YSI as the reference standard. This would indicate the algorithm's performance without the variability introduced by a lay user. The results state: "The In Touch® meter was 100% accurate within ±15 mg/dL at blood glucose concentrations <75 mg/dL and 100% within ± 15 mg/ml and blood glucose concentrations ≥75 mg/dL 99.7% within ±15 mg/dL meeting accuracy acceptance criteria."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth used was objective laboratory reference standards, specifically the YSI reference standard and/or mass spectrometry reference standard.

8. The sample size for the training set:

• The document does not explicitly state the sample size for the training set. The studies described are for "Non-Clinical Performance Characteristics" and "Clinical Performance Characteristics" to demonstrate verification, validation, and accuracy against established standards. These studies are typically for testing and validating the finished device, not for training a machine learning model. Blood glucose meters based on electrochemical enzymatic assays typically use calibrated chemical reactions and algorithms rather than large-scale machine learning training sets in the same way an AI imaging tool might.

9. How the ground truth for the training set was established:

• As there's no explicit mention of a training set in the context of a machine learning model, the concept of establishing ground truth for a training set in this manner is not directly applicable. The In Touch® Blood Glucose Monitoring System is based on established electrochemical biosensor technology and algorithms, not a machine learning approach that would require a distinct "training set" to learn from data. The device's 'training' or calibration would be through rigorous chemical and engineering principles rather than a data-driven ground truth process.

Ask a specific question about this device