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The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.

Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. 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 Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.

The two options for the sensor card are:

• Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
• Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium.

The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).

Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

The provided text describes a 510(k) premarket notification for the "Stat Profile Prime ES Comp Plus Analyzer System," an in vitro diagnostic device for measuring various blood parameters. It does NOT describe an AI/ML-based device. Therefore, the requested information regarding AI/ML acceptance criteria, training/test sets, expert ground truth establishment, MRMC studies, etc., cannot be extracted from this document as it is not relevant to the described device.

The document focuses on demonstrating substantial equivalence to a predicate device (Nova Stat Profile pHOx Ultra Blood Gas Analyzer) through performance testing typically required for in vitro diagnostic devices, such as method comparison, precision, linearity, specificity/interference, detection limit, and shelf life stability.

Here's a breakdown of what can be extracted, addressing the closest relevant points, and explicitly stating what cannot be found:

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

The document does not explicitly present a table of acceptance criteria paired with the specific numerical reported device performance for each analyte (e.g., pH, iCa, iMg, Hct). Instead, it broadly states that "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)." The study types performed are listed as:

• Method Comparison Studies
• Precision/Reproducibility Studies
• Run to Run Precision
• Linearity Testing
• Specificity / Interference Testing
• Detection Limit
• Shelf Life Stability Testing

Without the detailed test reports attached to this summary, the specific acceptance criteria thresholds and the measured performance values for each of these studies (e.g., specific bias ranges for method comparison, CV% limits for precision) are not available in this document.

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

• Sample Size: The document does not specify the exact sample sizes used for each performance test (method comparison, precision, linearity, etc.).
• Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for intended use, implying laboratory-conducted studies. No information on country of origin or whether the data was retrospective or prospective is provided.

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)

This question is not applicable. This device is an in vitro diagnostic analyzer, not an AI/ML system requiring human expert interpretation as ground truth for imaging or similar applications. The "ground truth" for the performance studies would be reference methods (for method comparison), known concentrations/values (for linearity/detection limit), or repeated measurements (for precision), all performed using established laboratory techniques, not expert consensus.

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

Not applicable. This is not a human interpretation study.

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 not an AI-assisted diagnostic device for human readers.

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

Not applicable. This is a standalone analytical device, but the term "standalone performance" in the context of your prompt usually refers to the accuracy of an AI algorithm on its own. For this device, all performance listed (method comparison, precision, etc.) is its standalone performance. The device operates without human-in-the-loop interpretation assistance, but rather as an automated analyzer whose results are then used by healthcare professionals.

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

The "ground truth" or reference values for this type of device would typically be:

• For Method Comparison: Results obtained from a well-established, validated reference method or another legally marketed device known for its accuracy.
• For Linearity: Samples with precisely known concentrations prepared gravimetrically or volumetrically.
• For Precision/Reproducibility: Statistical analysis of repeated measurements on stable samples.

The document does not specify the exact reference instruments or methods used, but this is the general approach for IVD devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." Its operating principles are based on ion-selective electrodes and impedance sensors, as described.

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

Not applicable. See point 8.

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The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, Potassium, and Chloride in heparinized venous whole blood, plasma and serum.

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

Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

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

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. 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 Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.

The two options for the sensor card are:

• . Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
• Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed ● analytes: pH, Hct, Na, K, CI, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure sodium, potassium, and chloride.

The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).

Calibration standards are provided in sealed pouches within a callbrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

This document describes the premarket notification for the Stat Profile Prime ES Comp Plus Analyzer System, a medical device for in vitro diagnostic use. It outlines the device's intended use, performance testing, and the conclusion that it is substantially equivalent to a predicate device.

Here's an analysis of the provided text, broken down by your requested categories:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it states that "Performance testing was completed to demonstrate that the Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent in performance, safety and efficacy to the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer (K110648)."

The performance tests conducted include:

• Method Comparison Studies
• Precision/Reproducibility Studies
• Run to Run Precision
• Linearity Testing
• Specificity / Interference Testing
• Detection Limit
• Shelf Life Stability Testing

The reported device performance, in relation to these tests, is a general conclusion: "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)."

Without specific numerical acceptance criteria (e.g., minimum accuracy, maximum bias, %CV for precision), a direct table comparison with specific values is not possible from the provided text. The acceptance criteria are implicitly that the new device's performance metrics (accuracy, precision, linearity, etc.) met or exceeded those of the predicate device, or fell within clinically acceptable ranges for such devices. The reported device performance is simply that it met these implicit criteria by demonstrating substantial equivalence.

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

The document does not specify the sample sizes used for any of the performance tests (Method Comparison, Precision, Linearity, etc.).

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for the test sets.

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 in the document. The device is an in vitro diagnostic blood analyzer, and its ground truth would typically be established by reference methods or other validated laboratory instruments, not by expert consensus in the way an imaging AI might.

4. Adjudication method for the test set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or expert consensus to resolve discrepancies, particularly for subjective assessments. This document describes an objective measurement device for chemical analytes, where "ground truth" is typically established instrumentally through reference methods, not through human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, the studies described are essentially standalone performance evaluations of the device. The "Stat Profile Prime ES Comp Plus Analyzer System" is an automated instrument that measures analytes. The performance tests (Method Comparison, Precision, Linearity, etc.) evaluate the device's output (measurements of Na+, K+, Cl-) against either reference methods or expected values, without human interpretive input affecting the measurement itself.

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

The document does not explicitly state the specific type of ground truth used for each test. However, for in vitro diagnostic devices like this, the ground truth for performance studies is typically established by:

• Reference methods: For method comparison studies, the device's measurements are compared against a recognized, often more laborious or expensive, reference measurement method or a well-established, previously validated clinical laboratory analyzer (the predicate device, in this case).
• Known concentrations: For linearity and detection limit studies, samples with precisely known concentrations of the analytes (e.g., prepared standards) are used as ground truth.
• Internal quality control materials: For precision and run-to-run variation, the consistency of measurements on stable, characterized quality control materials acts as a ground truth for reproducibility.

Given the context, the ground truth would be based on analytical reference methods or established comparator devices/standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This device is an analyzer that utilizes established ion-selective electrode technology and measurement algorithms. It's unlikely to have a "training set" in the sense of machine learning/AI models. The algorithms are based on electrochemical principles, not data-driven learning that requires a distinct training phase.

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

As there is no mention of a training set (as discussed in point 8), this question is not applicable. The device's "ground truth" for its development would be based on the established scientific principles of electrochemical measurement for ions.

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