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The FORA V20 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. 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 alternative site testing in the FORA V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA V20 test strips and control solutions with the FORA V20 Blood Glucose Monitoring System.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary for the FORA V20 Blood Glucose Monitoring System, focusing on demonstrating substantial equivalence to a predicate device (FORA TD-4245 Blood Glucose Monitoring System).

Here's what can be extracted and what is missing, based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in a quantitative table. The document claims "FORA V20 Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
• Reported Device Performance: Not explicitly provided in a quantitative table for the FORA V20. The document states a "comparison of system accuracy performance demonstrated that the FORA V20 Blood Glucose Monitoring System and the currently marketed FORA TD-4245 Blood Glucose Monitoring System are substantially equivalent." This implies performance was measured but the actual metrics are not detailed here.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not specified.

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 blood glucose monitoring system, not an imaging device typically involving human readers or AI assistance in a diagnostic capacity described by an MRMC study.

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

• The device performs a quantitative measurement of glucose. The nature of its operation is inherently "standalone" in calculating the glucose level. However, explicit details about a "standalone performance study" in the context of an algorithm's output vs. human interpretation are not present, as the device primarily provides a direct numerical reading.

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

• Not explicitly stated. For blood glucose monitors, the ground truth is typically a reference laboratory method (e.g., YSI analyzer) for glucose measurement. The document states "The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase," but doesn't detail the reference method used for comparison during testing.

8. The sample size for the training set:

• Not applicable/Not specified. This document pertains to the submission of a device for substantial equivalence, not the development of a machine learning algorithm with an explicit "training set" in the conventional sense. The "software modification to no-coding" and "software modification to use mg/dL as the preset measurement" are functional changes, not indicative of a machine learning model that undergoes training on a dataset.

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

• Not applicable/Not specified (as there's no explicit mention of a training set for an AI/ML model).

Summary of what is present:

• The device is a FORA V20 Blood Glucose Monitoring System.
• It measures glucose in fresh capillary whole blood from the finger and alternative sites.
• It's intended for use by healthcare professionals and people with diabetes mellitus at home.
• It's not for diagnosis or screening of diabetes mellitus, nor for use on neonates.
• It has a speaking functionality for visually impaired persons.
• The principle is electrochemical biosensor technology using glucose oxidase.
• The primary means of demonstrating suitability for market is through substantial equivalence to a predicate device (FORA TD-4245 Blood Glucose Monitoring System), noting similarities (operating principle, technology, circuit design, materials, shelf life, packaging, manufacturing process) and modifications (software for no-coding, Spanish speaking function, preset mg/dL).
• The document implies that the performance characteristics are the same as the predicate device and that software verification and validation confirmed equivalence in performance, safety, and effectiveness.

Conclusion based on the provided text:

The document primarily focuses on establishing substantial equivalence to a predicate device, rather than detailing a specific de novo study with explicit acceptance criteria, ground truth methodology, and performance metrics as if it were a new AI/ML diagnostic tool. Therefore, much of the requested information regarding detailed study design and acceptance criteria is not present in this 510(k) summary.

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