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The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.

The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.

The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.

The FreeStyle Precision Neo H meter provides the following features:

• Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
• Quality Control Reminder
• Out-of-Range Indicators

The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrical mediation.

The FreeStyle Precision Neo H System is compatible with the following components and accessories:

• FreeStyle Precision Neo H Blood Glucose Test Strips
• MediSense Glucose and Ketone Control Solutions
• FreeStyle Auto-Assist Neo Data Management System
• USB Cable

This document contains a 510(k) summary for the FreeStyle Precision Neo H Blood Glucose Monitoring System. The acceptance criteria and the study proving the device meets these criteria can be extracted from the performance data provided.

Here's the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document references ISO 15197:2013 as the standard for accuracy. The acceptance criteria for glucose monitoring systems, according to ISO 15197:2013 for system accuracy, are typically:

• ≥95% of all measured glucose values shall fall within ±15 mg/dL of the reference measurement procedure for glucose concentrations <100 mg/dL.
• ≥95% of all measured glucose values shall fall within ±15% of the reference measurement procedure for glucose concentrations ≥100 mg/dL.

The document states in the "Performance Standards" summary (not included here, but typically referenced as part of a 510(k) submission) that the device meets the requirements of ISO 15197:2013.

Let's assume typical clinical accuracy performance as reported in similar devices that meet ISO 15197:2013. The document implicitly states that the FreeStyle Precision Neo H Blood Glucose Monitoring System meets these criteria. While the exact table with specific numerical performance percentages is not provided in this excerpt, the declaration of meeting ISO 15197:2013 is the key.

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

• Sample Size (Test Set): Not explicitly stated in the provided text. The number of patients or samples used in the clinical accuracy studies (often referred to as the "test set" in AI/ML context) is typically detailed in the full performance study report which is summarized in the 510(k). This excerpt only broadly states "clinical studies."
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. Clinical studies are typically prospective studies where samples are collected specifically for the study.

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

• Number of Experts: Not applicable. For blood glucose monitoring systems, "ground truth" is established by a traceable reference measurement procedure, not by expert human graders. The reference method for glucose measurement (e.g., YSI analyzer or equivalent laboratory method) is considered the gold standard.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Ground truth for blood glucose is determined by a reference laboratory instrument, not by human adjudication.

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

• MRMC Study: No. This device is a standalone blood glucose monitoring system (an in-vitro diagnostic device). It does not involve human readers for image interpretation or direct human-AI interaction in the way an MRMC study would evaluate. Performance is assessed by comparing the device's readings directly to a laboratory reference method.

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

• Standalone Performance: Yes. The performance studies described (and the basis for meeting ISO 15197:2013) assess the accuracy of the device (meter and test strip, which includes the underlying chemical/electrical "algorithm") when operated according to its instructions for use. This is inherently a standalone performance evaluation against a reference method.

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

• Type of Ground Truth: The ground truth for blood glucose monitoring systems is established using a traceable laboratory reference method (e.g., a YSI glucose analyzer) that provides highly accurate and precise glucose concentration measurements.

8. The sample size for the training set

• Sample Size (Training Set): Not explicitly stated in the provided text. For in-vitro diagnostic devices like this, the "training set" doesn't typically refer to a machine learning context with distinct training data. Instead, it refers to the data generated during the development and optimization phases of the device (e.g., for calibrating the strips, optimizing the electronics). This information is usually proprietary and not detailed in the 510(k) summary beyond general statements of validation.

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

• Ground Truth (Training Set): Similar to the test set, the ground truth during the development and calibration phases would be established using traceable laboratory reference methods (e.g., YSI glucose analyzer). These reference measurements are used to ensure the device's readings are accurate across its operating range.

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