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The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is for single-patient use only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The AutoSure Voice II Blood Glucose Monitoring System consists of the AutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is used for testing of blood glucose by self-testers at home. The AutoSure Voice II Pro Blood Glucose Monitoring System consists of the AutoSure Voice II Pro Meter and AutoSure Pro Blood Glucose Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The AutoSure Voice II and AutoSure Voice II Pro systems are identical other than trade names and details of product labeling.

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Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

Device Name: AutoSure Voice II Blood Glucose Monitoring System and AutoSure Voice II Pro Blood Glucose Monitoring System

Reason for 510(k): The submission (K150396) appears to be for a modified version of an existing device (predicate device K102037). The modifications described are:
* Separation of self-testing and professional usage claims into two distinct products.
* Recommendation of four additional disinfectants in the User's Guides.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modified device and the "Clinical Testing" section explicitly states "No clinical testing was conducted," the document does not contain a typical table of performance acceptance criteria (e.g., accuracy, precision) and reported device performance from new clinical studies.

Instead, the primary "acceptance criteria" for this specific 510(k) submission are related to the safety and effectiveness of the modifications compared to the predicate device. The document implies that the device had already met performance criteria in its original K102037 submission.

The "Non-Clinical Testing" section describes the evaluation of the modifications:

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not specified in the provided document for the disinfection and robustness testing.
• Data Provenance: The testing was "Non-Clinical," meaning laboratory testing. There's no indication of patient data or country of origin mentioned for this specific K150396 submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for the non-clinical disinfection and robustness testing described. Ground truth for viral inactivation studies would typically involve laboratory standards and analytical methods, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable for the non-clinical disinfection and robustness testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "No clinical testing was conducted." This type of study would be clinical.

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

This refers to a Blood Glucose Monitoring System, which is a device for physical measurement, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the context of typical AI device evaluation. The device itself performs the measurement.

7. The Type of Ground Truth Used

For the non-clinical disinfection and robustness testing, the "ground truth" would be established through:

• For Disinfection: Laboratory standards for viral inactivation (e.g., demonstrating reduction in viral load by a certain log factor).
• For Robustness: Pre-defined performance specifications for the meter that must be maintained after undergoing repeated disinfection cycles. This would likely involve comparing measurements against a reference method or validated control solutions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The submission focuses on hardware and disinfectant compatibility.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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