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The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. 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 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.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. 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.

The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and how its performance was proven.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).

Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."

Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Method Comparison (POC vs. Lab):
    • Hct: 417 samples
    • SO2: 398 samples
    • tHb: 416 samples
    • O2Hb: 422 samples
    • COHb: 425 samples
    • MetHb: 437 samples
    • HHb: 322 samples
  • Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
  • Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
• Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

• This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
• The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.

6. Standalone Performance

• Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.

7. Type of Ground Truth Used

• Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
• Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.

8. Sample Size for the Training Set

• Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.

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

• Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.

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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 Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.

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, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) 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 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. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards.

Similar to the predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/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, 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.

The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.

Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.

For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."

The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."

Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.

Study Information:

1. Sample size used for the test set and the data provenance:

   • Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
   • Precision/Reproducibility - Within Run and Run to Run Studies:
     • Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
     • Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
     • The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
   • Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
   • Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.

4. 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 requiring human interpretation; it directly measures parameters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:

   • Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
   • Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
   • Linearity: Comparison against a "reference analyzer and/or the product specifications."
   • Specificity/Interference: Comparison of measurements with and without potential interfering substances.

7. The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.

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