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The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

lonized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

lonized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium),

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:

There are two options for the primary sensor card:

. Primary Sensor Card 1 shall enable and report the following listed analytes: o sodium, potassium, chloride, ionized calcium, and ionized magnesium
. Primary Sensor Card 2 shall enable and report the following listed analytes:

• sodium, potassium, chloride, ionized calcium, and ionized magnesium o

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood qas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:

The Stat Profile Prime Plus Analyzer System is comprised of the following components.

• Stat Profile Prime Plus Analyzer System .
• Primary Sensor Cartridge
• Auxiliary Sensor Cartridge ●
• Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
• Stat Profile Prime Plus Calibrator Cartridge ●
• Stat Profile Prime Plus External Ampuled Control ●
• IFU/Labeling .

Here's a summary of the acceptance criteria and study information for the Nova Biomedical Corporation Stat Profile Prime® Plus Analyzer System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the studies "meet the acceptance criteria" or "met the acceptance criteria" without explicitly listing the numerical acceptance criteria for many tests. The performance is reported as meeting these unstated criteria.

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

• Method Comparison Study:

  • Sample Size: Not explicitly stated. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using "blood comparison data."
  • Data Provenance: Conducted in a "clinical laboratory setting" as indicated by the study description. It is a prospective study as it involves active comparison of devices.

• Precision/Reproducibility Studies:

  • Within Run Precision: 20 replicates per run for each of the following: Stat Profile Prime Plus Internal Controls (Levels 4-5), Stat Profile Prime Plus Ampuled Controls (Levels 4-5), and three whole blood samples from syringes.
  • Run to Run Precision: Triplicate analyses on four whole blood samples in ten separate runs during a single day.
  • Data Provenance: The document doesn't specify country of origin. This appears to be prospective data generated for the study.

• Linearity Testing:

  • Sample Size: Not explicitly stated, beyond indicating "various medical decision limits" and "lower and upper limits of the AMR."
  • Data Provenance: Generated for the study.

• Specificity / Interference Testing:

  • Sample Size: Not explicitly stated for the number of samples, but tests were performed at "two analyte concentrations" for each potential interferent.
  • Data Provenance: Whole blood collected in lithium heparin vacutainers was used for this study. Generated for the study.

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

Not applicable. This device is an in vitro diagnostic device that directly measures analytes. The ground truth for performance studies is typically established by reference methods or validated predicate devices, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or data, and their initial interpretations need to be resolved by a consensus process. For an IVD device measuring analytes, the 'ground truth' is determined by the reference method's result, or the established result of a predicate device.

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. This is an In Vitro Diagnostic (IVD) analyzer, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

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

Yes, the studies described (Method Comparison, Precision, Linearity, Specificity/Interference) evaluate the standalone performance of the Stat Profile Prime Plus Analyzer System. The device directly measures the analytes and reports the results without human interpretation as part of its core function, other than healthcare professionals using the results for diagnosis and treatment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established by:

• Comparison to a predicate device: For the method comparison study, the Nova Stat Profile pHOx Ultra analyzer (K110648) served as the reference point for equivalence.
• Reference analyzers/specifications: For linearity testing, results were compared to "the reference analyzer and/or the product specifications."
• Internal controls and ampuled controls: For precision, these served as samples with known or expected values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a separate training set. The device operates based on established electrochemical principles (Ion-Selective Electrode) and measurement algorithms.

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

Not applicable, as no training set in the context of machine learning was used.

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