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The Precision Xtra / Optium Blood ß-Ketone Test Strips are intended to quantitatively measure blood ß-Ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood from the fingertip. The test strips are for use outside the body (in vitro diagnostic use) and are for self-testing or healthcare professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection. The test strip is to be used for ketone concentrations in persons with diabetes and other conditions.

The Precision® Xtra™ Diabetes Monitoring System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of ß-hydroxybutyrate (ß-ketone) present in the sample, providing a quantitative measure of ß-ketone in whole blood and control solutions.

The Abbott Precision Xtra Blood ß-Ketone Test Strips and Optium Blood ß-Ketone Test Strips are intended for the quantitative measurement of ß-ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood and, for healthcare professionals, in venous whole blood samples within 30 minutes of collection. The device is for in vitro diagnostic use, for self-testing or professional use by individuals with diabetes and other conditions requiring ketone monitoring.

A study was conducted to demonstrate the substantial equivalence of the Precision Xtra Blood ß-Ketone Test Strips/Optium Blood ß-Ketone Test Strips to predicate devices (Precision Xtra Blood ß-Ketone Test Strips K983504 and Optium Blood ß-Ketone Test Strips K040814/K050814).

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that various performance aspects were tested and passed, indicating they met established acceptance criteria, but it does not specify the numerical criteria themselves or the exact reported performance values. The performance studies verified the device through "non clinical testing in the laboratory."

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

The document does not explicitly state the sample sizes used for the non-clinical laboratory testing. The data provenance is stated as "non clinical testing in the laboratory," implying controlled laboratory conditions rather than patient data from a specific country. It is not specified whether the data was retrospective or prospective.

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

This information is not provided in the document. Given that the testing was "non clinical" and involved laboratory studies, it is unlikely that human experts were involved in establishing ground truth in the way described for clinical studies (e.g., radiologists interpreting images). Ground truth for these types of devices is typically established using a reference method or calibrated laboratory equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical laboratory testing, not a clinical study involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The performance studies were non-clinical laboratory tests comparing the device to its predicate devices, not evaluating human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance assessment was effectively done. The performance studies described are for the device (test strips) itself, evaluating its accuracy, precision, and other analytical characteristics in a laboratory setting, without direct human intervention in the result generation process beyond using the device as intended. The "algorithm" here would be the electrochemical reaction and measurement system of the biosensor technology.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth. However, for "non clinical testing in the laboratory" of a quantitative measurement device, the ground truth would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods (e.g., enzymatic reference methods for ß-ketone).
• Calibrated standards: Solutions with known, precise concentrations of ß-ketone.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set." The mentioned studies are performance verification for the device, implying that the device's design and underlying technology were already established. For this type of in vitro diagnostic device, "training sets" are not typically used in the same manner as for machine learning algorithms.

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

Not applicable, as no training set is mentioned or implied for this non-clinical performance verification.

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