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The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus.

The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges, and are easily performed by non-technical personnel. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with: Two analytical bays where the single use test cartridges are analyzed, Color Touchscreen Display, Barcode Scanner, Printer, Data Export Options, Ethernet Connection, USB Port.

Nova Allegro HbA1c Assay: The Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.

The provided text describes the performance testing of the Nova Allegro HbA1c Assay and Nova Allegro Analyzer for the quantitative determination of glycated Hemoglobin A1c (HbA1c) in capillary whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their outcomes, implying that meeting these outcomes constitutes the acceptance criteria. Explicit, numerical acceptance criteria are not always stated as "acceptance criteria," but rather as the successful outcome of the test.

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

• Linearity Testing: Eleven (11) linearity specimens.
• Interference Testing: Ten (10) replicate HbA1c tests per substance on prepared hemolysate specimens. Specific number of substances tested is indicated in Table 1 (40 substances).
• Total Hemoglobin Interference Testing: Not explicitly stated, but implies multiple HGB levels were tested.
• Method Comparison: A total of 526 subjects/specimens across four clinical sites.
  • Site 1: 156 samples
  • Site 2: 154 samples
  • Site 3: 102 samples
  • Site 4: 114 samples
• Precision (20-Day Imprecision - Controls): Two control solutions, each analyzed 80 times (20 days * 2 times/day * 2 duplicates) at each of four sites.
• Repeatability (Capillary Fingerstick Blood): 524 subjects from the Method Comparison study had a second fingerstick specimen collected and measured.
• Hemoglobin Derivative and Fractions, Hemoglobin Variants: Specific sample sizes for these tests are not provided, but imply testing of prepared specimens with varying concentrations.

Data Provenance:

• Country of Origin: Not explicitly stated, but "four (4) clinical sites" and "physician's offices" for point-of-care clinical performance studies indicate real-world clinical settings. The FDA submission suggests a US-centric regulatory and approval process.
• Retrospective or Prospective: The "Method Comparison" and "Precision" studies involved collecting and measuring samples, suggesting a prospective design for these clinical performance studies. The "Bench testing" for linearity and interference would be laboratory-based and controlled.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention "experts" in the context of establishing ground truth in the way one would for image-based AI studies (e.g., radiologists reviewing images).

For this device, the "ground truth" is established by a reference method or a "NGSP Certified central laboratory reference method" for HbA1c measurements, which are analytical instruments and laboratory processes, not human experts making subjective assessments.

• Method Comparison: Compared to an "NGSP Certified central laboratory reference method." NGSP (National Glycohemoglobin Standardization Program) certification implies a high standard of analytical accuracy and traceability to a primary reference method, essentially serving as a highly precise chemical/metrological "ground truth."

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative diagnostic test where the "ground truth" is established by a reference laboratory method, not by human interpretation or consensus that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging diagnostics or other subjective interpretation tasks where human readers' performance with and without AI assistance is evaluated. This device is a quantitative assay, with performance evaluated against a reference laboratory method and through precision studies, not human reader performance.

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

Yes, the performance data presented (Linearity, Interference, Total Hemoglobin Interference, Method Comparison against a reference lab, Precision, Hemoglobin Derivative/Fractions, and Hemoglobin Variants) represents the standalone performance of the Nova Allegro HbA1c Assay and Analyzer. The results are generated directly by the device and compared to established analytical standards or reference methods. There is no human-in-the-loop component in the device's measurement process that is being evaluated in these tests.

7. The Type of Ground Truth Used

• Reference Method/NGSP Certified Central Laboratory Reference Method: For Linearity and Method Comparison studies, the device's measurements were compared against a "reference method" and an "NGSP Certified central laboratory reference method." This is an analytical ground truth based on established, highly accurate laboratory techniques.
• Prepared Samples with Known Concentrations: For Interference testing, Hemoglobin Derivative and Fractions, and Hemoglobin Variants, prepared hemolysate specimens with known concentrations of interfering substances or variants were used. This constitutes a controlled, analytical ground truth where the expected outcome is known based on the sample preparation.
• Control Solutions: For 20-Day Imprecision testing, "Nova Allegro HbA1c Control Solutions" were used, which are materials with known, stable HbA1c values, serving as an analytical ground truth for precision assessment.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/algorithm. This device is a diagnostic assay and analyzer, not an AI algorithm that undergoes machine learning training. The "development" of such a device involves chemical and engineering optimization, and analytical validation. Therefore, the concept of a "training set" as understood in machine learning is not applicable here.

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

As noted above, the concept of a training set and its ground truth is not applicable to this type of medical device (a quantitative diagnostic assay). The device's operational range and internal calibration would be established through a process of characterization and calibration using traceable standards and reference materials, which is standard for analytical instruments.

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The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro UACR Assay: The Nova Allegro UACR Assay is a completely automated assay for the determination of albumin and creatinine in human urine. The results are used to calculate the UACR (Urine Albumin to Creatinine Ratio). Nova Allegro UACR Test Cartridges are the key element a user interacts with to determine the albumin and creatinine levels in a human urine sample. The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with:

• Two analytical bays where the single use test cartridges are analyzed
• Color Touchscreen Display
• Barcode Scanner
• Printer
• Data Export Options
• Ethernet Connection
• USB Port

The provided text is a 510(k) Summary for the Nova Allegro UACR Assay and Analyzer. It details the device's performance testing results. According to the prompt's request, I will extract relevant information to describe the acceptance criteria and the study proving the device meets these criteria.

It's important to note that this document describes a medical device, specifically an in-vitro diagnostic test, not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML specific quality evaluation criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," and details about training sets/ground truth for training, are not applicable in this context. The study performed is a performance validation of a diagnostic assay, comparing its results to a comparative method (CM), not a reader study.

Here's a breakdown of the requested information based on the provided document:

Device: Nova Allegro UACR Assay, Nova Allegro Analyzer
Indications for Use: The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful conclusion of each test and the statement that the data "meets the acceptance criteria" or "demonstrated no significant interference." Specific quantitative acceptance criteria are sometimes stated (e.g.,

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The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonatal heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System includes the following components:

• StatStrip Glucose Hospital Meter
• StatStrip Glucose Test Strips

StatStrip Glucose Hospital Meter System:
The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI).

StatStrip Glucose Test Strips:
The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips.

StatStrip Glucose Control Solutions:
The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

StatStrip Glucose Linearity Solutions:
There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

Charging (Docking) Station:
The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

Here's a breakdown of the acceptance criteria and study details for the StatStrip Glucose Hospital Meter System (K232075), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the FDA Guidance for POC Device Acceptance Criteria (Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, September 29, 2020). The performance of both the proposed and predicate devices is reported against these criteria.

| Acceptance Criteria (FDA Guidance) | Proposed Device Performance (

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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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood.

Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

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

Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.

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

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

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

Ionized Calcium (iCa) 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).

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).

The Stat Profile Prime Plus Analyzer System is an analyzer for use in 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.

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: .
  • PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium
• Primary Sensor Card 2 shall enable and report the following listed analytes: .
  • PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium

Auxiliarv Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

• . Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters
• Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters. .

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 ensures the analyzer is working properly.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.

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 Ampule Control
• . IFU/Labeling

Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.

Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:

• . pH
• . Partial Pressure of Carbon Dioxide (pCO2)
• Partial Pressure of Oxygen (pO2) ●
• Hematocrit (Hct) ●
• . Glucose (Glu)
• . Lactate (Lac)
• Sodium (Na) ●
• Potassium (K)
• Chloride (CI)
• . Ionized Calcium (iCa)
• . lonized Magnesium (iMg)

The Nova Biomedical Stat Profile Prime Plus Analyzer System is undergoing a 510(k) premarket notification to expand its indications for use to include capillary whole blood specimen testing for pH, pCO2, pO2, Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized Calcium (Ca2+), Ionized Magnesium (Mg2+), Glucose, Lactate, and Hematocrit. The study described focuses on demonstrating the substantial equivalence of the Stat Profile Prime Plus Analyzer system to its predicate device, the Nova Biomedical Stat Profile pHOx Ultra Analyzer, specifically for capillary whole blood samples.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily demonstrated through method comparison and precision studies. While explicit numerical acceptance criteria for each parameter (e.g., specific ranges for slope, intercept, r-value in method comparison, or max SD/CV% for precision) are not directly stated in the provided text as a standalone table, the conclusion sections for each study indicate that the device "met the clinical accuracy acceptance criteria" or "met the performance criteria for precision." The reported performance is shown in the tables below, which are the primary evidence for meeting the implicit acceptance criteria.

Method Comparison (Clinical Accuracy - Comparison to Predicate Device)

Precision (Laboratory and Point-of-Care Settings)

The precision data is presented across multiple tables (Tables 4, 5, 6, 7, 8, 9, 10). Rather than reiterating all data here, the text explicitly states:

• "The precision data for all samples in capillary mode met the within run and between analyzer imprecision specifications for the Prime Plus analyzers." (Summary of Capillary Mode Within Sample Precision)
• "This study demonstrates the Stat Profile Prime Plus analyzer exhibits clinically acceptable imprecision specifications for pH, pCO2, pO2, sodium (Na+), chloride (C1-), potassium (K+), ionized calcium (Ca2+), ionized magnesium (Mg2+), glucose, lactate, and hematocrit measured by the Stat Profile Prime Plus Analyzer System in Capillary mode." (Conclusion of Within-Run Imprecision - Capillary Mode Fingerstick (External POC))
• "The analyzer used for this evaluation met the performance criteria for within sample precision on capillary fingerstick specimens run by POC operators." (Conclusion of Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC))
• "The Stat Profile Prime Plus analyzers provided consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met the acceptance criteria for precision." (Conclusion of Within-Run Imprecision - Capillary Mode)

The acceptance criteria are therefore implicitly met by the reported r-values nearing 1.0 and slopes nearing 1.0 with intercepts near 0 for method comparison, and the CV% and SD values falling within acceptable limits (though the limits themselves are not numerically specified in the provided text).

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

• Method Comparison Test Set (Capillary Mode):

  • For each measured parameter, the sample size (N) ranged from 118 to 123 at the ER site and 123 to 128 at the Hemodialysis site. The combined sample size (N) for each parameter ranged from 241 to 251.
  • Provenance: This was a prospective clinical study conducted at two external Point-of-Care (POC) sites within the United States (an Emergency Room and a Hemodialysis Unit). Some samples (less than 10%, indicating "Altered Samples" ranging from 5 to 10 for each site) were altered to cover the full dynamic range. These were "de-identified and discarded arterial blood specimens" for the external precision study (implicitly reflecting human samples, though the exact origin beyond "external POC site" is not specified beyond being collected from patients).

• Precision Test Set (Capillary Mode):

  • Within Run Precision (Internal Lab): 20 replicates for each parameter, tested on two Prime Plus analyzers from venous blood transferred to capillary tubes. This appears to be lab-based, controlled samples.
  • Within Sample Precision (Internal Lab): 2 replicates from 30 different donors (Total N=60 for each analyte) of capillary whole blood. This implies human subjects.
  • Within-Run Imprecision (External POC): Sample analysis involved transferring discarded arterial blood specimens from a lithium heparin syringe to three balanced heparin capillary tubes. The number of unique discarded specimens is not explicitly stated but "each whole blood specimen" suggests multiple, distinct specimens were used.
  • Within-Sample Imprecision (Internal POC - Fingerstick): Capillary whole blood was collected via fingerstick puncture from individuals, with 2 replicates for each. N=60 for all sample pairs. This explicitly involves human subjects/donors.
  • Within-Run Imprecision (Internal Study - Lab): 5 different concentrations of deidentified venous whole blood specimens per analyte. Each concentration was run on 3 Prime Plus analyzers, 5 days, 1 run/day, 8 replicates/run/level. This totals 120 (5 concentrations * 3 analyzers * 5 days * 8 replicates) data points per analyte for the "N" value in Table 10. These are likely controlled lab samples simulating human blood.

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

The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth.

• For the method comparison study, the predicate device (Nova Stat Profile pHOx Ultra Analyzer) serves as the "ground truth" or reference method for comparison. The performance of this predicate device itself is assumed to be established and accepted.
• For the precision studies, the intrinsic analytical performance of the device is assessed, rather than against a human expert's interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective chemical and physical parameters rather than interpreting images or clinical signs that would require human adjudication. The "ground truth" is the measurement from the predicate device or the inherent value in the sample for precision studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

This information is not applicable as the device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements, not an AI imaging or diagnostic algorithm requiring human reader performance studies. The study focuses on instrument performance and equivalence rather than human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Yes, the studies conducted (method comparison and precision) are standalone performance evaluations of the device's accuracy and precision in measuring the analytes. There is no "human-in-the-loop" aspect to the analytical performance being evaluated; the device provides direct quantitative measurements.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference standard for comparison was the predicate device, the Nova Stat Profile pHOx Ultra Analyzer. This is a comparative method where the new device's performance is assessed against an already legally marketed and accepted device.
• Precision Studies: The "ground truth" for precision is the measured value itself and its statistical variation across multiple runs or samples. It's an assessment of the device's inherent reproducibility and repeatability, not against an external truth source like pathology or outcomes data. Human samples (venous and capillary whole blood) were used to test performance under realistic conditions.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this is not a machine learning or AI-driven device in the sense of requiring an explicit training phase with labeled data in the way an imaging algorithm would. This is an analytical instrument based on established sensor technology and algorithms. Therefore, discussions of training sets and their sample sizes are typically not relevant for this type of device submission. The device uses "the same sensor technology, measurement algorithms, formulations of the internal and external controls, and calibrator cartridge" as its predicate, implying a well-established design.

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

As no training set is discussed or implied to be applicable for this type of analytical device in the provided context, this question is not applicable.

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The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.

The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Nova Primary Glucose Analyzer System is a small, portable laboratory glucose analyzer that measures blood glucose levels in lithium heparinized whole blood or plasma utilizing a glucose oxidase based sensor and membrane/cap assembly.

The Nova Primary Glucose Analyzer accepts samples from syringes, blood collection tubes, microcentrifuge tubes, and sample cups. The sample size for analysis is 25 microliters (aspirated volume).

Nova Primary System Components:
The Nova Primary Glucose Analyzer System is comprised of the following components.

• Nova Primary Glucose Analyzer
• Nova Primary Glucose Sensor
• Nova Primary Glucose Membrane
• Nova Primary Calibrator Cartridge
• Optional Barcode Scanner
• IFU/Labeling

Sample Types:
The Nova Primary Glucose Analyzer System accepts lithium heparinized venous whole blood and plasma.

The Nova Primary Glucose Analyzer System by Nova Biomedical Corporation is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory settings for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.

The study presented does not explicitly list acceptance criteria in a tabular format with corresponding performance results. Instead, it describes performance testing conducted to demonstrate substantial equivalence to the predicate device, the YSI 2300 Stat Glucose and L-Lactate Analyzer. The performance tests included:

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

The "Summary of Performance Testing" section states, "The results of the performance testing confirmed that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer." This implies that the device met the criteria necessary to be considered substantially equivalent to the predicate device in terms of these performance characteristics. However, specific numerical acceptance criteria and the exact reported device performance metrics are not detailed in the provided text.

Here's an attempt to structure the information based on the provided text, while acknowledging the lack of explicit numerical acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the performance testing. It only mentions that "Testing was completed to show that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer."

3. Number of Experts for Ground Truth and Qualifications

This information is not provided in the document. The device is a laboratory instrument for quantitative determination of glucose, and ground truth would typically be established by recognized reference methods or predicate devices, not by human experts in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, the ground truth is based on objective laboratory measurements and reference methods, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric, often in image-based diagnostics. The Nova Primary Glucose Analyzer System is a quantitative measurement device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the performance testing described (Method Comparison, Precision/Reproducibility, Linearity, Specificity/Interference, Detection Limit, Shelf Life Stability) would inherently be a standalone evaluation of the algorithm and device's accuracy and reliability in measuring glucose concentration. The device is designed for automated quantitative measurement.

7. Type of Ground Truth Used

The ground truth for the device's performance is established by comparison to a legally marketed predicate device (YSI 2300 Stat Glucose and L-Lactate Analyzer) and traceability to isotope dilution mass spectrometry (for plasma equivalent glucose results). This suggests established laboratory reference methods and comparison to a 'gold standard' device.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an analytical device like this, the "training" (calibration and algorithm development) is typically an internal process, and the performance testing is done on independent samples.

9. How Ground Truth for the Training Set Was Established

The document states that "All glucose measurement algorithms are intended to report plasma equivalent glucose results that are substantially equivalent to the predicate device plasma glucose result, and are traceable to isotope dilution mass spectrometry." This implies that the algorithms were developed or "trained" using data and methods that align with these established analytical principles and reference standards. However, the specific details of how this "ground truth" was established for internal algorithm development (training) are not elaborated.

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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 Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium 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 same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Here's a breakdown of the acceptance criteria and study information for the Stat Profile® Prime Plus Analyzer System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it presents performance data (method comparison, imprecision) that would be evaluated against established clinical or analytical goals to demonstrate substantial equivalence. The predicate device's performance often serves as the de facto acceptance benchmark.

I will interpret the "Measurement Range" from Table 4 as an implicit acceptance criterion for the device's operational range, and the "Method Comparison Studies" and "Total Imprecision Performance" tables as reported device performance demonstrating equivalence.

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

• Method Comparison Studies (Test Set):

  • Sample Sizes:
    • Na: 432 samples (18 altered samples)
    • K: 435 samples (21 altered samples)
    • Cl: 434 samples (20 altered samples)
    • iCa: 434 samples (20 altered samples)
    • iMg: 426 samples (13 altered samples)
  • Data Provenance: The study was a Point-of-Care (POC) study conducted at 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data provenance is described as comparing "results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer." The specimens were either quality control materials or discarded blood gas specimens.
  • Retrospective or Prospective: Not explicitly stated, but the description of "comparing results obtained by trained Healthcare Professionals to results obtained by POC personnel" suggests a prospective collection or at least a controlled, concurrent comparison for the purpose of the study. It's not described as a retrospective analysis of existing patient data.

• Total Imprecision Performance (Test Set):

  • The estimates were obtained from different POC personnel running 3 levels of Quality Control/Linearity Materials in duplicate each day for a total of 20 runs on 3 analyzers. (Implies a substantial number of measurements, but the exact N for each measurement type is not detailed beyond "20 runs").

• Within-Run Whole Blood Precision (Test Set):

  • Each precision run consisted of ten (10) replicate measurements. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. This was done by a minimum of two (2) point-of-care operators at each of the three (3) POC sites, for a total of nine (9) operators.

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

The study compares the performance of the Stat Profile® Prime Plus Analyzer System against existing laboratory methods (referred to as "Lab" in Table 1) and its own predicate device.
For the Method Comparison Studies, the "ground truth" or reference method is the "Lab" result, which would typically be generated by a validated, high-accuracy laboratory analyzer. The document does not specify individual human experts or their qualifications for establishing this ground truth; rather, it refers to the "Lab" as the reference. For clinical laboratory devices, the "ground truth" is usually the result from a recognized reference standard method or a highly accurate laboratory instrument rather than individual expert consensus.

For the Imprecision studies, the "ground truth" is typically the measured mean of repeated measurements, and the accuracy is relative to a known value for Quality Control materials. Again, this doesn't involve human experts establishing ground truth in the way it might for imaging studies.

4. Adjudication Method for the Test Set

This type of diagnostic device (blood analyzer) does not typically involve human adjudication in the same way as, for example, image-based diagnostic systems. The method comparison studies compare the device's quantitative output to that of a reference laboratory method. No specific adjudication method like "2+1" or "3+1" is mentioned or applicable here.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic systems where human readers interpret medical images or data. The Stat Profile® Prime Plus Analyzer System is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that supports human interpretation in that manner. The study focused on demonstrating the analytical performance and equivalence of the device to a predicate and laboratory methods.

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

The device itself is a standalone analyzer that measures parameters and produces results. The performance studies (Method Comparison, Imprecision) evaluate the device's standalone analytical performance. Although POC personnel operate the device, the data presented (slopes, intercepts, r-values, %CV) reflects the intrinsic performance of the algorithm/hardware combination (the "device") in generating quantitative measurements, rather than human interpretation. So, yes, the performance metrics reported are for the device operating in a standalone capacity (as a measurement instrument).

7. The Type of Ground Truth Used

• Method Comparison Studies: The ground truth for the method comparison studies was obtained from a reference laboratory method or a "Lab" analyzer. This implies comparison to established, presumably accurate, laboratory instrumentation with well-defined performance characteristics.
• Imprecision and Within-Run Precision Studies: The ground truth for these studies relies on the known concentration values of quality control materials and the statistical analysis of repeated measurements to determine the reproducibility and variability of the device.

8. The Sample Size for the Training Set

The document does not describe the device as employing a machine learning or AI algorithm that requires a distinct "training set" in the conventional sense of AI/ML development. The device uses established "Ion-Selective Electrode (ISE)" technology and measurement algorithms. Therefore, there is no mention of a "training set" for an AI model.

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

As there is no mention of a "training set" for an AI model, this question is not applicable. The measurement principles are based on known electrochemical properties rather than learned patterns from a training dataset.

Ask a specific question about this device

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 and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.

Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.

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.

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 Glu. Lactate
• Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate

Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

• Auxiliary Sensor Card 1 shall enable Creatinine and BUN parameters .
• . Auxiliary Sensor Card 2 shall be a "dummy" sensor card, and will not report any parameters.

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.

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

This document describes the performance of the Stat Profile Prime Plus Analyzer System for the quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. The submission specifically focuses on the modification of the device to include Point-of-Care (POC) use.

It is important to note that this document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving novel clinical effectiveness with large-scale comparative effectiveness studies. Therefore, not all requested sections directly apply, especially those related to AI model development (training set, human-in-the-loop, MRMC studies) common in submissions for AI/ML-based diagnostic software. This device is a point-of-care blood analyzer, not an AI diagnostic software.

Here's the breakdown of the provided information within the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a singular table for all parameters as one might find for a pass/fail threshold in an AI/ML study. Instead, performance is demonstrated through various analytical validation studies (precision, linearity, interference, detection limit) and a method comparison study to show equivalence to a predicate device and laboratory methods. The "acceptance criteria" are implicitly met if the performance data supports substantial equivalence for the intended use and accuracy compared to established methods.

For Lactate (specifically detailed in the provided text):

• Within-Run (Quality Control Ampules Levels 4 & 5): CV% ranged from 0.00% to 1.6%.
• Within-Run (Whole Blood from Syringes, 5 samples): CV% ranged from 1.3% to 8.0%.
• Run-to-Run (Auto QC Cartridge Levels 4 & 5): Total Imprecision %CV ranged from 1.4% to 3.5%.
• Run-to-Run (Whole Blood, 5 samples): CV% ranged from 1.8% to 14.7%. Note: Blood #1 showed a higher CV of 13.3-14.7% across devices. |
  | Linearity | Demonstrates linearity across the claimed measurement range, with a high correlation (r-value) to established methods. | - Claimed Measurement Range: 0.3 - 20.0 mmol/L.
• Specimen Range Tested: 0.2 - 23.5 mmol/L.
• Analyzers (PP1, PP2, PP3): r-values were 0.9983, 0.9982, and 0.9988, respectively.
• Comment: Results support the claimed measurement range. |
  | Specificity / Interference | Identifies substances that may interfere and quantifies the highest concentration tested that shows no significant interference. | - Dose response study performed for glycolic acid and hydroxyurea showed interference at all concentrations. (Specific concentrations not given, but the fact of interference is noted).
• Table 7 lists the highest non-interfering concentrations for 23 other common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ethanol, Heparin, Ibuprofen). |
  | Detection Limit (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the lower limit of the claimed measurement range. | - LoB: 0.0 mmol/L
• LoD: 0.1 mmol/L
• LoQ: 0.1 mmol/L.
• Comment: All are below the claimed lower limit of 0.3 mmol/L. |
  | Method Comparison (POC vs. Lab) | Statistical agreement between the Stat Profile Prime Plus system (operated at POC by various personnel) and laboratory reference methods (implicitly, lab instruments or methodologies used for comparison). | - Analyte: Lactate
• N: 413 samples
• Range: 0.5 - 16.5
• Slope: 1.0181
• Intercept: -0.0796
• r (correlation coefficient): 0.9975
• 95% Confidence Interval Bias (2 mmol/L): 1.9-2.0
• 95% Confidence Interval Bias (6 mmol/L): 6.0-6.1 |
  | Total Imprecision Performance (POC)| Demonstrates acceptable total imprecision when operated by POC personnel. | - Lactate (Level 4): Mean 1.8 mmol/L, Total SD 0.1, Total %CV 3.2%
• Lactate (Level 5): Mean 6.7 mmol/L, Total SD 0.2, Total %CV 3.4%
• Lactate (Linearity Level 4): Mean 16.5 mmol/L, Total SD 0.4, Total %CV 2.2% |
  | Within-Run Whole Blood Precision (POC)| Demonstrates acceptable within-run precision for fresh whole blood samples in POC setting. | - Lactate (7 samples): Mean values varied (e.g., 3.30, 1.43, 2.47, 2.49, 1.24, 4.69, 11.4 mmol/L). Reported %CVs ranged from 4.08% to 6.68%. |

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

The "test set" in this context refers to the samples used in the analytical performance and method comparison studies.

• Sample Sizes:

  • Lactate Precision (Within-Run): 20 replicates for each level/sample type (QC, Ampules, Whole Blood) on 3 analyzers.
  • Lactate Precision (Run-to-Run): QC samples: 240 samples (2 runs/day for 40 runs * 3 analyzers); Whole Blood samples: 30 samples (triplicate analyses over 10 runs * 3 analyzers).
  • Linearity: 9 levels tested on 3 analyzers.
  • Interference: Not explicitly stated for each substance, but dose-response performed for problematic interferents.
  • Detection Limit: LoB: 5 runs on 2 analyzers; LoD: 4 runs on 2 analyzers for 5 low-level samples over 3 days (total 60 replicates per reagent lot); LoQ: 3 runs on 2 analyzers for 4 low-level samples over 3 days (total 36 replicates per reagent lot).
  • Method Comparison (POC vs. Lab): For Lactate: N=413 samples.
  • Total Imprecision (POC): 3 levels of QC/Linearity materials, run in duplicate each day for 20 runs on 3 analyzers.
  • Within-Run Whole Blood Precision (POC): 10 replicate measurements for 7 different whole blood samples at each site, by a minimum of 2 POC operators at 3 sites (total 9 operators).

• Data Provenance:

  • Country of Origin: Not explicitly stated but inferred to be the United States (given the FDA submission and the company address in Waltham, Massachusetts).
  • Retrospective or Prospective: The studies described (e.g., precision, linearity, method comparison) are typically prospective analytical validation studies conducted specifically for regulatory submission, using controlled conditions and fresh/altered samples collected for the purpose of the study. The POC study involved current operations ("discarded blood gas specimens" and "fresh, native and altered whole blood samples") and training of personnel for the study.

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

For this type of in vitro diagnostic device (blood analyzer), "ground truth" is established by comparison to reference methods or calibrated standards rather than expert consensus on images.

• Number of Experts: Not applicable in the context of expert readers for imaging or clinical diagnosis. The "experts" are the laboratory personnel operating the reference instruments and the Point-of-Care personnel who were "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized."
• Qualifications of Experts:
  • Laboratory Personnel: Implied to be qualified professionals operating the reference analyzers (e.g., Stat Profile pHOx Ultra Analyzer System, K110648).
  • Point-of-Care Personnel: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology personnel participated from 3 POC settings (Cardiothoracic Intensive Care Unit (CTICU), Emergency Department (ED), Respiratory Therapy Lab (RT)). They are described as "trained, qualified staff."

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML diagnostic software involving subjective interpretation or multiple expert reads needing adjudication. Performance is assessed analytically against reference methods or statistical metrics.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for AI/ML-based diagnostic software where the AI assists human readers in tasks like image interpretation. This submission is for an in vitro diagnostic device that directly measures analytes in blood. The study compared the device's performance to predicate devices and laboratory methods.

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

While the device's measurement process for each analyte (e.g., impedance, amperometry) can be considered "standalone" in that it performs the measurement algorithmically, the term "standalone performance" in the context of AI/ML usually refers to the accuracy of the algorithm without any human input during the diagnostic process.

For this device, the "measurements" are the direct outputs from the instrument. Its analytical performance (precision, linearity, detection limits, interference) is evaluated intrinsically (standalone from a human operator's interpretation, though a human initiates the test). The "Method Comparison Studies" then compare these outputs to a reference method, which is the closest equivalent to a "standalone" performance assessment for an IVD, demonstrating how well the device matches established lab results.

7. The Type of Ground Truth Used

The ground truth for this device's performance validation is based on reference methods and calibrated standards.

• Reference Methods: The "Method Comparison Studies" compare the Stat Profile Prime Plus Analyzer System's results (both in the lab and at POC) to those obtained from the predicate device (K180340) and/or other validated laboratory methods/instruments. For Lactate, the predicate K110648 (Stat Profile pHOx Ultra Analyzer System) was used for comparison.
• Calibrated Standards: Precision, linearity, and detection limit studies utilize quality control materials, calibrators, and prepared solutions with known concentrations. The linearity study specifically states comparison to "the reference analyzer and/or the product specifications defined in the Stat Profile Prime Marketing Requirements document."

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic analyzer (hardware and embedded software for physical measurement), not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "development" of its analytical components involves traditional engineering and chemistry, not machine learning training.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The physical and chemical principles of measurement (e.g., enzymatic reactions, amperometry, potentiometry) form the basis of the device's function.

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The Stat Profile Prime Plus Analyzer System is intended for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2) and Partial Pressure of Oxygen (pO2) in heparinized arterial and venous whole blood.

pH, pCO2 and pO2 Measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

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 same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device (Nova Stat Profile pHOx Ultra Analyzer System and K173797 - Stat Profile Prime Plus Analyzer System). The performance of the proposed device is compared to the predicate device and established CLSI guidelines for method comparison and imprecision.

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

• Sample Size for Method Comparison:
  • N = 432 for pH and pO2 (venous & arterial whole blood specimens combined)
  • N = 428 for pCO2 (venous & arterial whole blood specimens combined)
• Sample Size for Total Imprecision: 40 runs (duplicate measurements each day for 20 days) for each of 3 levels of quality control materials.
• Sample Size for Within-Run Whole Blood Precision: 10 replicate measurements for each of 5 different native whole blood samples at each site.
• Data Provenance: The studies were conducted at 3 Point-of-Care (POC) sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data provenance refers to real-world samples tested by clinical staff in typical POC settings. The report does not specify the country of origin, but given it's an FDA submission, it's typically understood to be within the U.S.
• Nature of Data: The method comparison used "discarded blood gas specimens" and "quality control materials" in addition to "fresh, native whole blood samples" for within-run precision. This indicates retrospective usage of discarded patient samples and prospective collection for precision studies.

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

The ground truth for the method comparison study was established by "laboratory measurements" (presumably by a predicate or established laboratory analyzer). The document does not specify the number of experts or their qualifications who performed these laboratory measurements. The term "POC personnel" refers to the users of the device under test, not the ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe any specific "adjudication method" in the sense of multiple experts reviewing results and reaching a consensus. For method comparison studies of this type (quantitative measurements), the reference method (laboratory measurement) typically serves as the "ground truth" against which the new device's performance is compared, using statistical methods (slope, intercept, correlation, bias). No expert adjudication is typically involved beyond ensuring the reference method itself is properly calibrated and operated.

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 explicitly done as described in the context of human readers improving with AI assistance. This device is an analyzer, not an AI-assisted diagnostic tool that interprets images or signals requiring human interpretation. The study involved different POC personnel operating the device, which is a form of multi-user testing to assess "imprecision performance" in a real-world setting, but it's not an MRMC study comparing human performance with and without AI.

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

Yes, the device operates in a standalone manner to measure pH, pCO2, and pO2. The "Point-of-Care (POC) study" assessed the device's performance when operated by healthcare professionals in clinical settings, but the device itself generates the quantitative measurements automatically. The "bench testing" mentioned, performed prior to the POC study, also represents standalone performance. The values in the tables are direct measurements from the device, not interpretations aided by humans.

7. The Type of Ground Truth Used

• For Method Comparison Studies: The ground truth was established by "laboratory measurements" using presumably a reference laboratory analyzer or the predicate device.
• For Imprecision Performance: The ground truth was based on the expected values of the "quality control materials" used.
• For Within-Run Whole Blood Precision: The study evaluated the device's consistency when repeatedly measuring "fresh, native whole blood samples", where the ground truth is simply the intrinsic value of the sample, and the measurement aims to show reproducibility.

8. The Sample Size for the Training Set

This document only describes performance testing for regulatory submission (510(k)). It does not mention or provide details about a "training set" as would be relevant for machine learning algorithms. This device is a diagnostic instrument based on established electrochemical principles, not an AI/ML device that requires a training set in the conventional sense.

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

As no training set is described for this type of device, this question is not applicable.

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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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