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The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or screening for diabetes mellitus, nor for use in neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains an audible readout function that provides an audible message of test results for users. The SOLUSmobile Blood Glucose Management System uses cellular data transmission to send test results to a cloud server, Telemed-Gluconet.

The SOLUSmobile Blood Glucose Test Strips are to be used with the SOLUSmobile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood from the finger and the forearm. These test strips are intended for use by a single patient with diabetes mellitus at home and should not be shared.

The SOLUSmobile Control Solutions are for use with SOLUSMobile Meter and Test Strips to check that the meters and test strips are working together properly and that the test is performing correction. A control test that falls within the stated range indicates the user technique is appropriate and the test strip and meter are functioning properly.

The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose meter, test strips, control solutions, a lancing device, lancets, battery charger and charging cable, and instructions for use.

To perform a test, a glucose test strip is inserted into the top of the monitor. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

An embedded cellular communications module within the SOLUSmobile meter enables automatic wireless data transmission over the Wireless cellular network between the meter and a Central Data Repository (Cloud server).

The test strips, control solutions, lancing device, and lancets are identical to previously cleared devices. The fundamental scientific technology of the SOLUSmobile except the device's communications capabilities remains unchanged from the legally marketed predicate device, SOLO V2 (K093764).

This document describes the SOLUSmobile Blood Glucose Management System (Model 6134), but it does not contain the specific performance study results, acceptance criteria, or most of the other requested details regarding clinical validation of glucose measurement accuracy.

The provided text focuses on:

• Device Description and Intended Use: Explains what the device is, how it works, and its purpose (quantitative measurement of glucose in capillary whole blood for diabetes management).
• Comparison to Predicate Device: Highlights changes from a previous model (SOLO V2), primarily related to wireless data transmission, battery improvements, and minor physical alterations.
• Performance Studies (General): Mentions that disinfection studies were performed to validate cleaning procedures and ensure efficacy against blood-borne pathogens (HBV). It also states robustness studies were conducted to simulate 3 years of use. It broadly refers to "verification and validation testing" to assess changes and demonstrate that "design outputs... meet the predetermined acceptance criteria of the design input requirements."
• Conclusion: States that the device demonstrates "satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device."
• FDA K-Number Letter and Indications for Use: Standard regulatory documents.

Missing Information:

The document explicitly states "Performance Studies" but then only details disinfection and robustness studies, along with a general statement about meeting predetermined acceptance criteria. It does not provide data from studies assessing the accuracy of the glucose measurements themselves (e.g., against laboratory reference methods, or ISO 15197 standards). Therefore, I cannot extract the specific acceptance criteria for glucose accuracy or the reported device performance in those terms.

Without this crucial information, I cannot complete most of the requested table and detailed bullet points.

Based on the available information, here is what can be inferred or stated about the device and its validation, with clear indications of what is missing:

1. Acceptance Criteria and Reported Device Performance

For Glucose Measurement Accuracy:

• Acceptance Criteria for Glucose Measurement: NOT PROVIDED IN THE TEXT. Typically, blood glucose meters are evaluated against standards like ISO 15197, which define accuracy criteria (e.g., a certain percentage of results within ±15% or ±20% of a reference value for different glucose ranges). This document does not state such criteria or present results that meet them.
• Reported Device Performance for Glucose Measurement: NOT PROVIDED IN THE TEXT. The document does not share any data on the accuracy (e.g., bias, precision, percentage agreement with a reference method) of the SOLUSmobile's glucose readings.

For Disinfection Efficacy and Robustness (the only studies detailed):

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

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Sample size (number of subjects, number of blood samples) and data provenance for studies demonstrating glucose measurement accuracy are not mentioned.
• For Disinfection and Robustness Studies: Sample sizes for these specific studies (e.g., number of devices tested for disinfection, number of cycles for robustness) are not precisely stated, though "11,000 cycles" are mentioned for robustness. Data provenance (e.g., country of origin, retrospective/prospective) for these studies is not specified, other than being conducted by "an outside testing service."

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

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Ground truth for glucose accuracy typically involves a highly accurate laboratory reference method (e.g., YSI analyzer), rather than expert consensus. No details on this are provided.
• For Disinfection and Robustness Studies: Not applicable to "experts" for ground truth in the traditional sense; these are laboratory-based tests.

4. Adjudication method for the test set

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT.
• For Disinfection and Robustness Studies: Not applicable.

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 device is a blood glucose meter, not an AI-powered diagnostic imaging system requiring human reader interpretation. No MRMC study was done, nor would it be relevant for this type of device.

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

• YES, implicitly. Blood glucose meters inherently operate in a "standalone" fashion (algorithm-only) to measure and display glucose values. The output is directly presented to the user. The document implies this by discussing the meter's function and wireless transmission of results. However, direct "standalone performance" data (like accuracy metrics) are not provided.

7. The type of ground truth used

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., YSI glucose analyzer) that measures plasma glucose concentration.
• For Disinfection Efficacy: Live virus (HBV) was used.
• For Robustness: Performance of the meter and external materials.

8. The sample size for the training set

• NOT APPLICABLE / NOT PROVIDED IN THE TEXT. This device is not described as using a machine learning algorithm that requires a "training set" in the context of diagnostic pattern recognition. The fundamental technology is electrochemical, detecting glucose concentrations directly.

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

• NOT APPLICABLE / NOT PROVIDED IN THE TEXT. As the device is not described as having an AI-driven "training set" for its core function, this question is not relevant.

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