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The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance.

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

Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

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

Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the callbration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of sodium and ionized calcium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) and associated evaluators.

Clinical Context: Rapid analysis of heparinized whole blood samples in clinical and central laboratory settings for diagnosis and treatment of electrolyte imbalances.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets for each performance metric, but rather presents the results of various studies and states that "all results were within specification" or "all parameter levels passed specification," implying that the observed performance met predefined internal acceptance criteria.

Below is a table summarizing the reported device performance from the various studies. The "Acceptance Criteria" column reflects the implied successful performance indicated by the text.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

  • Internal Precision (Aqueous Controls): 120 replicates per control level per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Process Control Solutions D & E): 120 replicates per PCS per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Whole Blood): 120 replicates per concentration level per analyte (3 analyzers x 5 days x 1 run/day x 8 replicates = 120).
  • Reproducibility (Aqueous Controls - POC): 90 replicates per control level per analyte (3 sites x 3 replicates/run x 2 runs/day x 5 days = 90).
  • External Precision (Whole Blood):
    • POC Sites: 30-54 samples for Na+, 30-54 for K+, 30-54 for Cl-, 27-54 for Ca++ (per site)
    • Central Labs (Lab1, Lab2) / CSL: 30-33 samples for Na+, 30-33 for K+, 30-36 for Cl-, 27-33 for Ca++ (per site/lab)
  • Linearity: 9 or 10 levels per analyte, each analyzed in triplicate (9-10 levels x 3 replicates per level = 27-30 measurements per analyte).
  • Method Comparison (GEM Premier 5000 vs. GEM Premier 4000): 373 samples for each analyte (Na+, K+, Cl-, Ca++).
  • Clinical Testing (Normal Mode Syringe Samples): 485-491 samples per analyte.
  • Clinical Testing (Native Capillary Samples): 171 samples for Na+ and Ca++.
  • Clinical Testing (Pooled Native & Contrived Capillary Samples): 201 samples for Na+, 205 samples for Ca++.

• Data Provenance: The data is a mix of internal studies (Instrumentation Laboratory Co.) and external studies at clinical point-of-care (POC) sites and central laboratories.

  • Internal Studies: Conducted by Instrumentation Laboratory Co. (Bedford, MA, USA). Some CSL (Customer Simulation Laboratory) data included contrived samples.
  • External Studies: Performed at:
    • Three (3) external clinical point-of-care (POC) sites.
    • Two (2) external central laboratories.
    • One (1) internal Customer Simulation Laboratory (CSL) at IL, with POC users.
  • Retrospective/Prospective: The studies appear to be prospective, designed specifically to evaluate the GEM Premier 5000's performance as per CLSI guidelines. The whole blood samples used in precision and method comparison studies include both native patient samples and, in some cases, contrived samples. The native clinical samples would be analogous to retrospective data if collected prior, but the studies describe active collection and testing to compare performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number or qualifications of "experts" used to establish ground truth in the traditional sense (e.g., radiologists, pathologists). Instead, laboratory reference methods and predicate devices are used as the "ground truth" or reference for comparison.

• Ground Truth for Analytical Studies:
  • Traceability: For Process Control Solutions (PCS), it states "traceable to NIST standards, CLSI procedures or internal standards."
  • Reference Analyzers: For Linearity, results were "compared to reference analyzers."
  • Predicate Device: For Method Comparison and Clinical Testing, the GEM Premier 4000 (K133407) served as the predicate device for comparison.

Since this is a clinical chemistry device for measuring electrolytes, the "ground truth" is typically established by highly calibrated and validated laboratory reference methods or proven predicate devices, rather than expert interpretation of images or clinical assessments.

4. Adjudication Method

Not applicable for this type of device performance study. Adjudication methods (like 2+1 or 3+1 expert consensus) are typically used in studies involving subjective assessments, such as radiology image interpretation, to establish a definitive ground truth when there might be inter-reader variability. For quantitative measurements by clinical chemistry analyzers, the ground truth is established by objective reference methods or well-characterized predicate devices.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating the impact of an AI system on human reader performance, often in diagnostic imaging. This document describes the analytical and clinical performance of a clinical chemistry device, which does not involve human "readers" interpreting cases in the same way. The studies focus on the device's accuracy, precision, linearity, and comparability to a predicate device.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was conducted for the device. The entire suite of analytical and clinical studies (precision, linearity, analytical specificity, method comparison) evaluates the performance of the GEM Premier 5000 system (which includes its embedded processing/algorithm) as a standalone diagnostic tool without direct human-in-the-loop interpretation of results that would alter the quantitative measurement it produces. The output values are direct physical measurements.

7. Type of Ground Truth Used

The ground truth used for this device includes:

• Reference Methods/Standards: For internal precision and calibration, traceability to NIST standards, CLSI procedures, or internal standards is mentioned for Process Control Solutions. "Reference analyzers" were used for linearity comparisons.
• Predicate Device Performance: For method comparison and clinical testing, the GEM Premier 4000 served as the gold standard or reference for comparison, indicating substantial equivalence.
• Known Concentrations: Contrived samples (e.g., in the CSL) were used to cover medical decision levels, implying that their concentrations were known or precisely measured by a separate method.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Given that this is a 510(k) submission for an in vitro diagnostic device, the "training" for such devices typically refers to the extensive development and internal testing/calibration cycles that occur before formal validation studies (like those presented in the performance section) are conducted. These early development data sets are generally not disclosed in 510(k) summaries but are part of the design control process. The performance data presented are from validation studies, which serve as the test set.

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

As noted above, a distinct "training set" with established ground truth in the AI/ML sense is not detailed. However, the process for establishing "ground truth" during device development (analogous to training) would involve:

• Calibration Standards: Using certified reference materials and multi-point calibration procedures to ensure the device's sensors and algorithms accurately translate raw signals into quantitative concentrations.
• Inter-Instrument Reproducibility: Extensive internal testing against known values to optimize sensor performance and ensure consistency across multiple manufacturing units.
• Method Development & Optimization: Iterative testing with various samples (potentially including contrived and real patient samples) to refine the measurement algorithms and internal quality control mechanisms (like iQM2) to detect and correct errors. These steps would ensure measurements align with established reference methods or predicate devices.

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The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.

The GEM Premier 4000 is a portable critical care system. The potassium (K+) sensor membrane on the GEM Premier 4000 is being modified to lower the valinomycin concentration, along with a proportional decrease in the amount of counterion.

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

Device: GEM® Premier 4000 with modified K+ sensor membrane

1. Table of Acceptance Criteria and Reported Device Performance (Summary derived from the document):

• Level 1 (2.90 mmol/L): Total Imprecision %CV = 1.51%
• Level 2 (3.88 mmol/L): Total Imprecision %CV = 1.32%
• Level 3 (7.41 mmol/L): Total Imprecision %CV = 0.86%
  Full Capillary Mode:
• Level 1 (3.06 mmol/L): Total Imprecision %CV = 3.55%
• Level 2 (4.06 mmol/L): Total Imprecision %CV = 2.71%
• Level 3 (7.44 mmol/L): Total Imprecision %CV = 2.16%
  Micro Capillary Mode:
• Level 1 (3.34 mmol/L): Total Imprecision %CV = 3.31%
• Level 2 (4.25 mmol/L): Total Imprecision %CV = 2.66%
• Level 3 (7.83 mmol/L): Total Imprecision %CV = 1.27%
  Conclusion: All K+ results for whole blood precision were within specification. |
  | Linearity | Support the current claimed reportable range of 0.2 to 19.0 mmol/L. | Syringe Mode: y = 1.0144x - 0.0612 (R² = 0.9999), y = 1.0085x - 0.0038 (R² = 0.9999), y = 1.0438x - 0.165 (R² = 1)
  Full Capillary Mode: y=1.0115x + 0.0251 (R² = 0.9997); y = 1.0302x - 0.1058 (R² = 0.9998); y = 1.0324x - 0.0435 (R² = 0.9996)
  Micro Capillary Mode: y = 1.068x - 0.136 (R² = 0.9999), y = 1.0791x - 0.2189 (R² = 0.9998), y = 1.1017x - 0.2881 (R² = 0.9994)
  Conclusion: Linearity results support the claimed reportable range of 0.2 to 19.0 mmol/L for all sampling modes. |
  | Interferences | No clinically significant interference from common substances, or a specific limitation added if observed. | Only citrate at concentrations ≥ 7.3 mmol/L showed a clinically significant interference effect. A limitation was added to labeling: "Blood collection tubes containing sodium citrate as an additive will produce a clinically significant change in potassium and should be avoided." |
  | Method Comparison (Internal) | K+ performance comparable to the GEM Premier 3000. | Syringe: Slope = 0.978, R² = 0.998
  Full Capillary: Slope = 0.980, R² = 0.997
  Micro Capillary: Slope = 0.987, R² = 0.997
  Conclusion: K+ performance is comparable to the GEM Premier 3000 for all sample modes. |
  | Field Site Testing (External) | K+ performance comparable to the GEM Premier 3000/3500 in a clinical setting. | Syringe: Slope = 1.050, R² = 0.989 (Range 2.0 to 7.5 mmol/L)
  Full Capillary: Slope = 1.018, R² = 0.957 (Range 2.3 to 5.6 mmol/L)
  Micro Capillary: Slope = 0.996, R² = 0.963 (Range 2.3 to 5.6 mmol/L)
  Conclusion: K+ performance in the clinical setting is comparable to the GEM Premier 3000/3500 for all sample modes. |

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

• Precision Study:
  • Sample Size: 3 sample levels (whole blood). Each level was assayed twice per day in eight replicates for five days. This totals 2 (assays/day) * 8 (replicates) * 5 (days) = 80 measurements per level per analyzer for each mode. With 2 analyzers, this is 160 measurements per level per mode.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing) using whole blood samples. It's retrospective in the sense that the data was collected for the purpose of this submission, but not from an ongoing patient cohort.
• Linearity Study:
  • Sample Size: Whole blood samples at 7 different K+ concentrations. Each concentration was tested in duplicate on the reference Flame Photometer and in triplicate on 3 different GEM Premier 4000 analyzers for each of the 3 sample modes. This implies 7 (concentrations) * 3 (replicates) * 3 (analyzers) = 63 measurements per sample mode.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing) using manipulated whole blood samples.
• Interference Study:
  • Sample Size: Substances were tested, but the number of samples or replicates is not specified.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-based (internal testing).
• Method Comparison (Internal):
  • Sample Size: 220 samples for each sample mode (syringe, full capillary, micro capillary).
  • Data Provenance: Internal study, likely laboratory-based.
• Field Site Testing (External):
  • Sample Size: 454 samples for syringe mode, 304 samples for full capillary, and 304 samples for micro capillary.
  • Data Provenance: Clinical setting at three field sites. This implies prospective collection or anonymized retrospective patient samples from those sites.

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

• This is not an AI/imaging device study, so the concept of experts establishing ground truth for a test set in the traditional sense is not directly applicable.
• For the Linearity study, "Flame atomic emission photometry (flame photometry)" was used as the reference method (ground truth). This is an established analytical technique, not a human expert.
• For Method Comparison and Field Site Testing, the predicate devices (GEM Premier 3000 and 3500) served as the reference standard for comparison, rather than human expert opinion.

4. Adjudication Method for the Test Set:

• Not applicable as this is a medical device performance study, not a study involving human interpretation needing adjudication. The "ground truth" was established by objective reference methods or comparison to predicate devices.

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

• No, this was not an MRMC comparative effectiveness study. This is a performance study for an in vitro diagnostic (IVD) device (blood analyzer) measuring specific analytes, not a study evaluating human reader performance with or without AI assistance for tasks like image interpretation.

6. Standalone (Algorithm Only) Performance:

• Yes, the studies are primarily standalone performance assessments of the device itself. The device, the GEM Premier 4000 with the modified K+ sensor, is an automated analytical instrument. The studies evaluated its analytical performance (precision, linearity, interference, method comparison) without direct human intervention in the K+ measurement process beyond sample collection and instrument operation.

7. Type of Ground Truth Used:

• Objective Reference Methods and Predicate Device Comparison:
  • Precision: Internal specifications (implied criterion).
  • Linearity: Flame atomic emission photometry (a recognized gold standard analytical method for K+).
  • Interferences: Clinical significance based on established medical understanding of K+ variations.
  • Method Comparison: GEM Premier 3000 (the previous version of the device).
  • Field Site Testing: GEM Premier 3000/3500 (predicate devices in a clinical setting).

8. Sample Size for the Training Set:

• Not Applicable. This submission describes modifications to an existing device's sensor and subsequent validation studies. There is no mention of a "training set" in the context of machine learning or AI models. The device's underlying technology (potentiometric measurement) is based on electrochemical principles, not trained algorithms.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the described device and studies. The device's performance is governed by its sensor design and calibration, which are validated through the studies outlined.

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