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The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the Stat-Sensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary. venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

The Nova StatSensor Creatinine Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The Nova StatSensor Creatinine Hospital Meter System is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, the meter stores patient test data, QC test data, and other information relating to patient sample, operator, reagents, and the meter. A user interface provides a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

The document describes the Nova StatSensor Creatinine Hospital Meter System, which is intended for quantitative measurement of creatinine in whole blood.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance data from a study. Instead, it describes the device and states that its performance characteristics (measuring range, sample type, measuring technology, operating principle, analysis time, sample volume, sample application, meter calibration, controls, linearity solutions, and test strip reagents) are the "Same as Predicate" device (K070068).

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed new clinical study results for acceptance criteria. The claim of "Same as Predicate" for performance implies that the predicate device's acceptance criteria and performance data are being relied upon, but these are not explicitly listed or provided for the proposed device in this document.

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

This information is not provided in the document. The document states that "No changes have been made to Nova StatSensor Creatinine Test Strips and they are not a subject of this submission," and similar for control and linearity solutions. It also states the proposed device uses "the exact same technology, functionality, analytical and operational performance characteristics, as the predicate." This suggests that new analytical or clinical studies for the performance of the device were not conducted as part of this submission for the proposed device, as it is claiming equivalence based on unchanged performance characteristics.

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

This information is not provided. As explained above, no new performance study data (and thus no ground truth establishment process for such a study) is detailed in this 510(k) summary.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI components in this device description. The device is a "Creatinine Hospital Meter System" which measures creatinine directly from a blood sample using electrochemical biosensor test strips. It is not an AI-assisted diagnostic imaging or interpretation device.

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

This is not applicable. The device is a point-of-care meter system, not an algorithm. Its performance is inherent in the meter and test strip system.

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

This information is not provided for the proposed device. For a creatinine test system, the "ground truth" for analytical performance studies would typically be established by validated reference methods (e.g., laboratory-based creatinine assays with established accuracy and precision). However, as noted, new performance study data is not detailed here.

8. The sample size for the training set

This information is not provided. The document is not about a machine learning or AI algorithm that would typically involve a "training set."

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

This information is not provided and is not applicable to this type of device.

Summary of what is provided and what is missing:

• Acceptance Criteria/Performance: The document states the proposed device has the "Same as Predicate" performance characteristics, including measuring range, acceptable samples, measuring technology, operating principle, analysis time, sample volume, and meter calibration. However, the specific quantitative acceptance criteria and detailed performance data (e.g., accuracy, precision) are not explicitly listed for either the predicate or the proposed device in this summary.
• Studies: The document acts as a 510(k) summary to establish substantial equivalence for a modified device (ergonomic design changes) to an existing predicate. It asserts that the modified device uses the "exact same technology, functionality, analytical and operational performance characteristics" as the predicate. Therefore, it does not detail new analytical or clinical studies to demonstrate performance because it relies on the predicate's established performance.
• Specifics (Sample Size, Experts, Adjudication, Ground Truth, AI, MRMC): None of these details are available in the provided text, as the submission focuses on claiming equivalence rather than detailing new performance studies.

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