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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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ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E 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 system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" to 7.75".

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

This monitor contains some speaking functions but is not intended for use by the visually impaired.

The kit of ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System consist of four main products: the monitor features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K041107), and the lancet device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

The provided text does not contain detailed acceptance criteria and performance data for the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E. It primarily consists of a 510(k) summary indicating substantial equivalence to a predicate device based on similar operating principles, fundamental scientific technology, basic circuit design, materials, shelf life, and manufacturing process.

The document states that "Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is equivalent to the predicate device." However, it does not present the specific acceptance criteria or the reported device performance from those tests.

Therefore, I cannot populate the requested table or provide specific details on sample sizes, ground truth establishment, expert qualifications, or study methodologies as this information is not present in the provided text.

The text does indicate:

• Type of Ground Truth Used (training and test set): Not explicitly stated, but for blood glucose, systems typically compare results against a laboratory reference method. For blood pressure, comparison is usually against a validated reference device (e.g., sphygmomanometer with auscultation).
• Sample Size for Training Set: Not mentioned.
• How the Ground Truth for the Training Set was Established: Not mentioned.

In summary, the provided document focuses on the regulatory submission for substantial equivalence rather than a detailed presentation of performance study results against specific acceptance criteria.

Ask a specific question about this device