GEM PREMIER 4000

• K Number: K112995
• Device Name: GEM PREMIER 4000
• Manufacturer: INSTRUMENTATION LABORATORY CO.
• Date Cleared: 2012-05-03 ( 209 days)
• Product Code: CEM , CGA , CGZ , CHL , CIG , GHS , GKF , GKR , GLK , GLY , JFP , JGS , JJY , KHP , MQM
• Regulation Number: 862.1600
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: K093623 , K061974

Intended Use

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.

Device Description

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.

AI/ML Overview

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):

Test Type	Acceptance Criteria (Implied/Expected)	Reported Device Performance (with modified K+ sensor)
Precision	K+ results for whole blood precision must be "within specification" (details of specification not explicitly stated, but implied by conclusion).	Syringe Mode:

• 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.

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.