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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 pH and pO2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO2 from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status.

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

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of pH and pQ2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO₂ 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 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. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Step 1: After inserting the GEM PAK, the instrument will perform an automated PAK warm-up during which the sensors are hydrated and a variety of checks occur, all of which take about 40 minutes. During warm-up, the instrument requires no user intervention.
Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions (PC Solution D and E) that are traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte, are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system.
Step 3: After successful performance of APV, iQM2 manages the quality control process, replacing external quality controls.
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 GEM Premier 5000 is a medical device designed for the rapid analysis of heparinized whole blood samples for pH, pCO2, and pO2 measurements. The provided document is a 510(k) summary, which demonstrates substantial equivalence to a predicate device (GEM Premier 4000) for these parameters.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the studies aim to demonstrate that the device performs "within specification" or shows "substantial equivalency" to the predicate device and recognized standards (CLSI guidelines). The reported performance is summarized below, with an implied acceptance that these values fall within expected clinical or analytical ranges and compare favorably to the predicate.

The reported performance values are presented as part of precision studies, linearity studies, analytical specificity (absence of interference), and method comparison against predicate devices or reference methods. The "acceptance criteria" are implicitly met if the reported values demonstrate acceptable precision, linearity, and agreement with reference methods/predicate devices.

The total error calculations are compared against "GEM Premier 5000 Total Error Specifications," which are not explicitly provided in the document but are indicated as having been met.

2. Sample Sizes and Data Provenance

The document provides sample sizes for various tests:

• Internal Precision Study - Aqueous Controls: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Precision Study - GEM PAK Process Control Solutions D and E: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Precision Study - Whole Blood: n=120 per analyte per sample mode per level (3 analyzers, 5 days, 1 run/day, 8 replicates/run). Data provenance is internal (Instrumentation Laboratory Co.).
• Reproducibility Study with Aqueous Controls – POC Setting: n=90 per material/level (3 external POC sites, 9 operators, 3 instruments, 5 days, 2 runs/day, 3 replicates/run). Data provenance is external Point-of-Care sites within the USA (implied as no other country explicitly mentioned). This was a prospective study.
• External Precision – Whole Blood:
  • POC Setting: n=30 to 54 per site (various N given per analyte/mode/site) for pH, pCO2, pO2. Pooled POC data: pH (N=102-126), pCO2 (N=117), pO2 (N=45-51). Performed by 11 operators on 3 instruments. Data provenance is 3 external POC locations, prospective.
  • Central Lab Setting: n=24 to 30 per site. Pooled lab data: pH (N=90), pCO2 (N=78), pO2 (N=66-72). Performed by 3 operators on 3 instruments. Data provenance is 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL). It includes native and contrived specimens. This was a prospective study.
• LoB, LoD, and LoQ: LoB, LoD, LoQ were established using three (3) lots of GEM Premier 5000 PAKs (cartridges). Specific sample sizes for individual measurements within the establishment process are not detailed, but the method used is CLSI EP17-A2. Data provenance is internal (Instrumentation Laboratory Co.).
• Linearity: 8 or 9 levels per analyte, 9 replicates per level (on 3 test analyzers). Total N per analyte: 72-81. Data provenance is internal (Instrumentation Laboratory Co.).
• Analytical Specificity: Interference study with various substances. Specific N for each substance not detailed, but it involves screening tests at two different analyte concentrations. Data provenance is internal (Instrumentation Laboratory Co.).
• Internal Method Comparison:
  • pH: N=373 clinical samples.
  • pCO2: N=150 clinical samples.
  • pO2: N=148 clinical samples.
    Data provenance is internal, using clinical samples. These were retrospective or prospective, but likely prospective as samples were "altered as needed to cover the medical decision levels."
• Clinical Testing (Method Comparison):
  • Normal Mode (Syringe Samples): pH: N=479; pCO2: N=492; pO2: N=506. Pooled data from 3 external POC sites and 1 internal Customer Simulation Laboratory (CSL). Data includes patient samples. This was a prospective study.
  • Native Capillary Samples: N=171 for pH, N=167 for pO2. Collected at an external POC site (N=65) and an internal CSL (N=106). Data provenance is external POC site and internal CSL. This was a prospective study.
  • Pooled Capillary Results (Native + Contrived): pH: N=189; pO2: N=218. The contrived samples were prepared internally. Data provenance is external POC site, internal CSL, and internal contrived samples. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the device's performance. Instead, ground truth for quantitative measurements of blood gases and pH is established using:

• Reference materials/standards: NIST standards, CLSI procedures, internal standards (for calibration and control solutions).
• Predicate devices: The GEM Premier 4000 serves as the predicate for method comparison studies.
• Reference methods: Tonometry is used as a reference for pO2 and pCO2 in Linearity and Internal Method Comparison studies due to instability of blood gases.

The quality control process (iQM2) also uses "Process Control (PC) Solutions" whose values are traceable to NIST standards, CLSI procedures, or internal standards.

4. Adjudication Method

No adjudication method (e.g., 2+1, 3+1 consensus) is described because the ground truth is established through quantitative measurements against reference materials, reference methods, or comparison to a predicate device, rather than subjective expert interpretation requiring consensus.

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

No MRMC comparative effectiveness study was done. The device measures quantitative laboratory parameters (pH, pCO2, pO2) and does not involve human readers interpreting images or data where "AI assistance" would be relevant in the context of diagnostic performance improvement. The studies focus on analytical performance metrics like precision, accuracy, and linearity.

6. Standalone Performance Study

Yes, standalone performance was done. All the precision, linearity, LoB/LoD/LoQ, analytical specificity, and method comparison studies described are standalone performance studies. These studies evaluate the device's ability to accurately and precisely measure pH, pCO2, and pO2 in various conditions (aqueous controls, whole blood, different modes) independently. The "method comparison" studies compare the device's readings directly against a predicate device or a reference method.

7. Type of Ground Truth Used

The ground truth used for the studies is based on:

• Calibration and Control Solutions: Values traceable to NIST standards, CLSI procedures, or internal standards.
• Reference Methods: Tonometry for pCO2 and pO2 in linearity and method comparison studies.
• Predicate Device: The GEM Premier 4000 for method comparison studies for pH.
• Clinical Samples: Patient samples (heparinized whole blood, native capillary samples) are used for precision and method comparison studies, with their "true" values established by the reference methods or predicate device for comparison. For some internal precision studies and clinical testing, contrived samples are also used to extend the tested range.

8. Sample Size for the Training Set

The document describes premarket validation studies for a medical device that performs quantitative measurements, not a machine learning or AI model that requires a "training set." Therefore, there is no "training set" in the context of AI model development mentioned or implied in this document. The studies are validation studies demonstrating the device's performance against established analytical standards.

9. How Ground Truth for the Training Set Was Established

As noted above, this device does not involve a "training set" in the context of AI/ML. The measurements and comparisons are against established analytical methodologies and reference values.

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