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The Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.

The Precision® /Optium® Point of Care Blood Glucose Test Strips work on the principle of amperometric biosensor technology, by determination of glucose oxidised by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD). The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10 phenanthroline quinone (1,10PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the meter, after applying lot specific information from the supplied ROM calibrator and after a 20 second countdown, a concentration value is presented to the user.

The provided document is a 510(k) summary for the Precision® Point of Care Blood Glucose Test Strip and Optium® Point of Care Blood Glucose Test Strip. It describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical and clinical performance data.

However, the document does not contain the detailed information required to answer all the questions about specific acceptance criteria and the comprehensive study details. It generally states that "studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent" and lists some types of tests performed (altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life) but does not provide:

• A table of specific acceptance criteria values.
• Reported device performance against those specific criteria.
• Sample sizes for test sets or training sets.
• Data provenance for either training or test sets.
• Details on expert involvement, ground truth establishment, or adjudication methods for either training or test sets.
• Information on MRMC studies or standalone algorithm performance.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided in detail. The document states that the device "passed" various tests like "altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life." However, no specific numerical acceptance criteria (e.g., "accuracy within X%") or the exact reported performance values are given. The general conclusion is that the performance is "acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not specify the sample sizes used for the clinical or non-clinical testing. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be determined. For a blood glucose test strip, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., a YSI analyzer), not by human expert consensus or radiologists. The document does not mention the involvement of experts in establishing ground truth, as it's not relevant for this type of device.

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

• Not applicable / Cannot be determined. Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies where human readers interpret results. For a blood glucose test strip, the "reading" is a numerical value, and the comparison is to a reference instrument, not a human interpretation.

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. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for software-as-a-medical-device (SaMD) or AI-powered diagnostic tools, especially in imaging. This document describes a physical medical device (blood glucose test strips) that provides a direct numerical measurement. There is no AI component or human reader interpretation in the sense of an MRMC study.

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

• Not applicable in the usual sense. This is a hardware device (test strip) that works with a monitoring system. Its "performance" is the accuracy and precision of the glucose measurement it provides, which is inherently "standalone" in that it produces a value. There's no separate "algorithm only" performance to speak of outside of the integrated system. The clinical and non-clinical studies verify the performance of the strip used with the meter.

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

• Implied reference method comparison. For a blood glucose test strip, the ground truth for accuracy and precision studies would be established by comparing the device's readings against a highly accurate laboratory reference method (e.g., a YSI glucose analyzer, typically considered the gold standard for glucose measurement in lab settings). While not explicitly stated, this is the standard practice for such devices. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Cannot be provided. The document does not discuss a "training set" in the context of machine learning. The device is based on "amperometric biosensor technology" and does not appear to involve a machine learning model that would require a dedicated training set. It is a chemical-electronic measurement system.

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

• Not applicable, as no training set is discussed.

Summary of what is known:

• Device: Precision® / Optium® Point of Care Blood Glucose Test Strips.
• Technology: Amperometric biosensor technology, using Glucose Dehydrogenase (GDH) and Nicotinamide Adenine Dinucleotide (NAD) to detect glucose.
• Performance verified by: Non-clinical (laboratory) and clinical testing.
• Tests performed (general categories): Altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping, and shelf life.
• Conclusion: The device is substantially equivalent to the predicate device (K021960) and suitable for its intended use.
• Ground Truth (inferred): Likely established by comparison to a laboratory reference method for glucose measurement.

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