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The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface.

The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

The Osmetech OPTI LION Electrolyte Analyzer is a medical device intended for the measurement of pH, sodium, potassium, ionized calcium, and chloride in whole blood, serum, plasma, and aqueous controls. The following information details the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for each analyte. Instead, it refers to the "medically allowable errors as defined in CLIA'88 performance standards" as the benchmark for comparison. The study's conclusion is that the device's performance is acceptable against these standards.

Without specific numerical acceptance criteria from the document, we can infer the performance metrics reported as evidence of meeting an unspecified acceptable level based on CLIA'88 standards.

2. Sample Size for the Test Set and Data Provenance

The document states: "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and plasma or serum collected for routine analysis on existing instrumentation." This indicates the data provenance is retrospective, using pre-existing patient samples. The country of origin of the data is not specified, but the applicant company is based in Roswell, GA, USA.

The exact sample size for the test set is not explicitly stated in the provided text.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance of the OPTI LION Electrolyte Analyzer was correlated against "predicate devices" in a clinical setting. This implies the "ground truth" was established by measurements from these predicate devices.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned. The comparison was made against predicate devices, which likely involved direct comparison of numerical results.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study focused on comparing the device's performance against predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The "clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices." This implies that the device (algorithm only, as it's an automated analyzer) was run on samples and its results were compared to those of existing predicate devices. The operation by "personnel minimally qualified to perform and report these results" indicates a human-in-the-loop for operation, but the performance being assessed is that of the analyzer itself.

7. The Type of Ground Truth Used

The ground truth used was established by measurements obtained from predicate devices. The document states, "Clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices in a clinical setting." The "predicted systematic differences and their 95% confidence intervals between the OPTI LION and the predicated devices" were then compared to CLIA'88 performance standards.

8. The Sample Size for the Training Set

The document focuses on the validation of the device and does not provide information about a "training set" in the context of machine learning or AI models. This device is an analyzer that uses optical fluorescence and factory-calibrated cassettes, rather than an AI model that undergoes a training phase with a specific dataset. Therefore, the concept of a training set as typically understood for AI algorithms does not apply here, and no sample size for a training set is provided.

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

Given that the device is an analyzer based on optical fluorescence and factory-calibrated cassettes, it does not have a "training set" in the AI sense. Its calibration is performed during manufacturing, and each cassette contains bar-coded calibration information.

The description of calibration states: "Each lot of OPTI LION cassettes is calibrated during the manufacturing process... The OPTI LION system uses a proprietary dry calibration process... This dry-to-wet (mid-physiologic) relationship is stable and consistent for all sensors in a lot, and is characterized and bar-coded at the factory. In addition, the sensor's wet response curve of the fluorescent intensity versus analyte level is factory-characterized and bar-coded."

Therefore, the "ground truth" for the device's operational parameters (akin to a training phase in AI) is established through factory characterization and calibration based on known concentrations of analytes and the relationship between dry and wet fluorescent intensities. This is an engineered calibration rather than a data-driven training process with human-established ground truth.

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