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ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System, Model TD-4276, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.

The device is not to be used for the diagnosis or screening of diabetes or tested on neonates.

The kit of ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System consist of four main products: the meter with blood glucose measurement function, test strips, control solution (cleared under K041107), and a lancing device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

The provided text describes a 510(k) summary for the ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states: "The ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System has the same performance characteristics as the predicate device."

Therefore, to complete this table, one would need to refer to the performance characteristics and acceptance criteria established for the predicate device (ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4223F, K072039). The current document only asserts equivalence without detailing those characteristics.

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

This information is not provided in the document. The filing discusses "Software verification and validation testing" but does not give details about sample sizes, country of origin, or whether the study was retrospective or prospective.

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

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically come from a laboratory reference method, not necessarily from human experts in the way it would for imaging diagnostics. However, the document does not specify how the ground truth was established for the performance evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a blood glucose monitor, a typical adjudication method (like 2+1 expert consensus) would not apply directly. The performance is assessed against a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable/provided. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images. This device is a blood glucose monitor, which provides a quantitative measurement directly, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study

The document implies a standalone performance study was conducted to demonstrate equivalence to the predicate device, stating: "The ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System has the same performance characteristics as the predicate device. Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System is equivalent to the predicate device."

However, the specific details of this standalone performance, such as metrics (accuracy, precision, linearity), are not provided. The assessment relies on equivalence to a predicate rather than reporting new standalone performance data against a set of criteria.

7. Type of Ground Truth Used

This is not explicitly stated, but for a blood glucose monitor, the ground truth would typically be established by a laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory instrument) for blood glucose measurement. The document does not specify the method used.

8. Sample Size for the Training Set

This information is not provided in the document. Blood glucose monitors usually don't have a "training set" in the machine learning sense, unless their algorithm involves adaptive learning, which is not indicated here. The "development" of the device's algorithm would involve calibration and optimization against controlled samples, but "training set" is not a standard term in this context for such devices.

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

This information is not provided and is largely not applicable in the machine learning sense for this type of device. If there was an internal development process, the ground truth would be established through a laboratory reference method during calibration and verification.

Summary of what's present and what's missing:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K072039) rather than providing a detailed study with specific acceptance criteria and performance data for the new device. The assertion is that "The ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System has the same performance characteristics as the predicate device," and therefore the details of the predicate device's performance would be required to understand the implied acceptance criteria and performance.

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