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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 glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient's metabolite balance.

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

Lactate (Lac) measurement is used:

• to evaluate the acid-base status of patients suspected of having lactic acidosis;
• to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.

Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of glucose, lactate and total bilirubin from venous, arterial and capillary 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.

The provided text describes the performance of the GEM Premier 5000 device for measuring Glucose, Lactate, and Total Bilirubin. The document primarily focuses on analytical and clinical studies to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria against a specific benchmark.

However, we can infer acceptance criteria based on the "Total Error Observed" compared to "Total Error Specifications" in the "Whole Blood Performance at Medical Decision Levels" section. The document states, "Total Error was computed based on the following equation and the results were compared to the GEM Premier 5000 Total Error Specifications." This implies that the 'Total Error Specifications' are the acceptance criteria.

1. Table of acceptance criteria and the reported device performance:

Note: The document explicitly states "All results were within specification" for precision studies and "All parameter levels passed specification for all sample modes" for internal method comparison, and "The analytical and clinical study results demonstrate that the GEM Premier 5000 is safe and effective for its intended purpose and equivalent in performance to the predicate devices." While specific numerical acceptance criteria (Total Error Specifications) are not detailed in the provided excerpts, the text indicates that the observed total error for Glucose, Lactate, and tBili met these internal specifications. For the clinical testing section concerning capillary samples, a "TEa" (Total Error Allowable) is given, which serves as an acceptance criterion for those specific tests.

Capillary Samples Acceptance Criteria (TEa) and Performance:

2. Sample sizes used for the test set and data provenance:

• Internal Precision Study - Aqueous Controls: N=120 per analyte/level for each of the 3 controls (GEM System Evaluator and CVP 5 tBili). The study was internal to the manufacturer (Instrumentation Laboratory Co.).
• Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E: N=120 per analyte/level for each of the 2 solutions. The study was internal to the manufacturer.
• Internal Precision Study – Whole Blood: N=120 per analyte/level/sample mode (Normal and Micro) for five different concentrations of whole blood. The study was internal to the manufacturer.
• Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: N=90 pooled data (30 replicates per level) per analyte/level. This involved 3 external clinical POC sites, suggesting prospective data collection in a point-of-care setting.
• External Precision - Whole Blood: Patient samples were tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. At least two whole blood specimens were analyzed in triplicate daily for 5 days. Specific "N" values for each site and analyte are provided in the tables within the document (e.g., for Glu Normal Mode, POC1 N=51, POC2 N=39, POC3 N=27, CSL N=33, Lab1 N=30, Lab2 N=30). Data provenance is a mix of internal CSL (contrived and native specimens) and external clinical labs and POC sites (patient samples), implying prospective collection of patient samples.
• LoB, LoD, LoQ: Three (3) lots of GEM Premier 5000 PAKs (cartridges) were used.
• Linearity: Nine (9) levels per analyte, each analyzed in triplicate on three (3) GEM Premier 5000 test analyzers. Data provenance appears to be internal.
• Analytical Specificity: Interference study conducted on the GEM Premier 5000. Data provenance appears to be internal.
• Internal Method Comparison: N=373 for Glucose and Lactate, N=163 for tBili. Clinical samples were used, and samples were altered as needed to cover medical decision levels. Data provenance appears to be internal to the manufacturer, comparing to predicate devices.
• Clinical Testing (Method Comparison in POC):
  • Glucose and Lactate (Normal Mode): N=489 for Glucose, N=488 for Lactate. Pooled results from 3 external POC sites and 1 internal CSL. This included patient samples and spiked samples (at CSL).
  • Glucose and Lactate (Native Capillary Samples): N=171. Pooled results from an external POC site and the internal CSL using finger-stick samples.
  • Glucose and Lactate (Contrived Capillary Samples): N=197 for Glucose, N=201 for Lactate. Pooled native capillary samples with additional contrived capillary samples prepared internally.
  • Total Bilirubin (Normal, Capillary, and tBili/CO-Ox Modes): Against Roche Cobas 6000: N=53 (Normal), N=58 (Capillary), N=53 (tBili/CO-Ox). Against Ortho Clinical Diagnostics Vitros 5600: N=76 (Normal), N=77 (Capillary), N=77 (tBili/CO-Ox). Pooled results from external POC sites with neonate samples, adult samples, and spiked samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts for establishing ground truth. The devices being compared are laboratory diagnostic instruments. Therefore, "ground truth" is likely established by reference methods or predicate devices, which are themselves high-accuracy laboratory instruments (e.g., GEM Premier 4000, ABL 837, Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600). The "experts" in this context would be the technicians or clinical laboratory scientists operating these reference systems, though their specific qualifications are not stated.

4. Adjudication method for the test set:

Not applicable. This is a medical device performance study, not a clinical trial with human interpretation requiring adjudication. Performance is assessed by comparing results to established reference methods or predicate devices.

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 document pertains to an in vitro diagnostic device for quantitative measurements of analytes, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the studies presented are essentially "standalone" evaluations of the device's analytical performance, without direct human interpretation being part of the measurement process itself. The device (GEM Premier 5000) provides quantitative measurements, and its accuracy and precision are assessed against reference methods. While human operators are involved in running the device and collecting samples, the device's output is a direct quantitative result, not an interpretation that is then refined or improved by a human.

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

The "ground truth" for the performance studies is established through comparative analysis with predicate devices (GEM Premier 4000 for glucose and lactate, ABL 837 for total bilirubin) and commercially available laboratory reference analyzers (e.g., Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600) for total bilirubin. These predicate and reference devices represent highly accurate and established measurement methods in clinical chemistry.

8. The sample size for the training set:

Not applicable. This document describes the validation of a laboratory instrument, not a machine learning model that requires a "training set." The device's performance is based on its internal design, sensors, and chemical reactions, which are validated through empirical studies rather than algorithm training.

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

Not applicable, as there is no "training set" in the context of this device validation.

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