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The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium 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 (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.

• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lacidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of ed cells).
• · DH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Glu, Lac, Hct, pH, and pCO2. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color 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.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

The provided text describes a 510(k) premarket notification for the GEM Premier ChemSTAT device, a portable system for analyzing whole blood samples. The document focuses on demonstrating substantial equivalence to a predicate device (GEM Premier 4000) through various performance studies.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in a single table, but rather implied through the successful completion of various performance studies and the conclusion that "All results were within specification." The reported device performance is presented in several tables detailing precision, linearity, and method comparison.

Here's a compilation of the reported device performance, which implies the acceptance criteria were met if these results were deemed "within specification":

Table of Reported Device Performance (Implied Acceptance Criteria)

Study Details:

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

   • Internal Precision Study – Whole Blood: 5 concentrations of whole blood per analyte, run on 3 analyzers for 5 days, 8 replicates per run per level (N=120 per level/analyte).
   • Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: 7 levels (Glucose, Lactate) or 6 levels (Hct, pH, pCO2) of quality control material, run in triplicate, twice a day for 5 days (30 replicates per level). Pooled N=90 across 3 sites for each control level for each analyte.
   • External Precision – Whole Blood: Various N values per analyte and POC site, ranging from 3 to 198 (pooled). The text states "Less than 10% of samples included in the study were contrived." This indicates the majority are real patient samples.
   • LoB, LoD, and LoQ: Not specified how many physical samples, but performed using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
   • Linearity: Minimum of 9 levels per analyte (whole blood spiked or diluted). Each blood level analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers (except pH and pCO2, which were tested on 3 analyzers). N per level: 18 for Glucose, Lactate, Hematocrit; 9 for pH, pCO2.
   • Analytical Specificity: Not explicitly stated N, but various test substances were screened at specified concentrations.
   • Clinical Testing (Method Comparison):
     • Glucose: N=432
     • Lactate: N=432
     • Hematocrit: N=431
     • pH: N=552
     • pCO2: N=559
     • Provenance: Lithium heparinized whole blood patient samples from the intended use population. Samples from three (3) external point-of-care (POC) sites and an internal Customer Simulation Laboratory (CSL). Less than 10% of samples were contrived. This implies the data is a mix of prospective (patient samples from POC sites) and potentially some retrospective (if sourced from a biobank, though "patient samples" often implies prospective collection for the study) and/or controlled spiked samples. The specific country of origin is not stated but "external point-of-care (POC) sites" and "internal Customer Simulation Laboratory (CSL) at IL" (Instrumentation Laboratory Co., Bedford, MA) suggest US-based data.

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

   • This document describes in vitro diagnostic (IVD) device performance against established analytical methods and a predicate device, not an AI/ML device relying on human expert interpretation of images. Therefore, the concept of "experts establishing ground truth" in the sense of radiologists or pathologists for an AI model's output does not directly apply here.
   • The "ground truth" for the test set values (sample concentrations) for analytes like Glucose, Lactate, Hct, pH, and pCO2 would typically be established by a reference method or the established predicate device (GEM Premier 4000) itself, which is considered the "truth" for comparison in the method comparison study. The laboratory professionals operating these devices and following standard protocols implicitly ensure the accuracy of these reference values.
   • For the reproducibility study, "nine (9) different operators" were involved at "three (3) external clinical point-of-care (POC) sites". These would be healthcare professionals (e.g., nurses, lab technicians) trained to use the device. Their qualifications are not specified beyond being "health care professionals."

3. Adjudication Method for the Test Set:

   • Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective human interpretation of data, often for diagnostic image analysis where disagreement among readers needs resolution.
   • For an IVD device measuring quantitative analytes, the "ground truth" is typically the result from a reference standard instrument or method. Discrepancies are usually investigated through analytical means (re-testing, troubleshooting) rather than human adjudication of interpretive differences. The document does not mention any such adjudication process.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:

   • No, an MRMC study was not done. MRMC studies are specifically designed for evaluating diagnostic tools where human readers interpret cases, often with and without AI assistance (e.g., radiology AI).
   • This submission is for an IVD device for quantitative measurements of analytes, not an AI/ML-driven diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

   • This device is an IVD instrument, not an algorithm/software in the typical AI sense. Its performance (accuracy, precision, linearity) is inherently "standalone" in how it processes a blood sample to produce a result, without needing human "in-the-loop" interpretation of the measurement itself.
   • Clinical testing (method comparison) directly assesses the device's standalone performance against a predicate device.

6. The Type of Ground Truth Used:

   • The ground truth for the analytical studies (precision, linearity, LoB/D/Q, specificity) is based on analytical standards, control materials with known concentrations, and comparison to a legally marketed predicate device (GEM Premier 4000).
   • For the clinical testing/method comparison, the predicate device (GEM Premier 4000) provides the comparative "ground truth" for patient samples, ensuring the new device yields comparable results within acceptable ranges. This is a common approach for IVD substantial equivalence.

7. The Sample Size for the Training Set:

   • This document describes a conventional IVD device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on established electrochemical and conductivity principles (Amperometry, Potentiometry, Conductivity), not on learning from a large dataset.
   • Therefore, there is no explicit "training set" size or process described. The "training" of such a device involves its initial design, calibration protocols, and quality control procedures during manufacturing, which are validated through the performance studies presented.

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

   • As there is no "training set" in the AI/ML context, this question is not applicable to the GEM Premier ChemSTAT device as described. The "ground truth" for calibrating and setting up an IVD device's internal algorithms (e.g., sensor response curves, temperature compensation) would be established using traceable reference materials and industry-standard analytical methods during the device's development and manufacturing.

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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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.

• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
• · COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
• · MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygenation status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status.

· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 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 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.
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.

The provided text describes the GEM Premier 5000, a portable critical care system for analyzing heparinized whole blood samples. It focuses on the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device (GEM Premier 4000) for Hematocrit and CO-Oximetry measurements.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for precision or method comparison studies in a single table with target values. Instead, it presents the "Within Analyzer SD/CV" and "Total SD/CV" or "Bias" for various analytes and compares them to specifications which are indirectly implied to be the acceptance criteria. For the purpose of this response, I will interpret "SD/CV Spec" as the acceptance criteria for reproducibility and "Medical Decision Levels" with a calculated "Total Error Observed" compared to an unstated "GEM Premier 5000 Total Error Specifications" as acceptance criteria for accuracy.

Here's a table summarizing the reported device performance based on the precision and method comparison studies:

Table 1: Summary of Device Performance against Implicit Criteria

Note: For the Total Error Observed, the document states these were compared to "GEM Premier 5000 Total Error Specifications," but these specifications are not explicitly provided in the text for all analytes. However, for capillary clinical testing, specific TEa values are given for some analytes, which are used here as proxies for acceptance criteria where available.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Internal Precision Study (Aqueous Controls):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (GEM PAK Process Control Solutions):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (Whole Blood):
  • Sample Size: 120 per analyte/sample mode (3 analyzers, 5 days, 1 run/day, 8 replicates/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective. Origin of whole blood samples likely internal or procured, not specified by country.
• Reproducibility Study (Aqueous Controls – Point-of-Care (POC) Setting):
  • Sample Size: 90 per analyte/level (3 external POC sites, 3 different GEM Premier 5000 instruments, triplicate measurements, twice a day, total 30 replicates per level, pooled).
  • Data Provenance: External clinical POC settings, prospective. Country of origin not specified, but likely USA based on the FDA submission.
• External Precision (Whole Blood - Central Lab and POC settings):
  • Sample Size: Varies by analyte and site (e.g., Hct Normal Mode POC-All N=126, CSL N=36, Lab1 N=30, Lab2 N=30). The overall study involved multiple whole blood specimens (at least two per day) analyzed in triplicate daily for 5 days.
  • Data Provenance: 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. Prospective, "contrived whole blood specimens were analyzed in addition to native specimens" in the CSL. Country of origin not specified, but likely USA based on the FDA submission.
• Analytical Specificity (Interference Study):
  • Sample Size: Not explicitly stated as a single "test set" size for all substances, but experiments were conducted with various concentrations of interfering substances.
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Method Comparison (Clinical Samples):
  • Sample Size: Varies by analyte (N=376 for Hct, N=373 for O2Hb, etc.).
  • Data Provenance: Clinical samples (heparinized whole blood) altered as needed to cover medical decision levels. Internal study, retrospective/prospective hybrid (samples altered to cover ranges).
• Clinical Testing (Point-of-Care Setting - Normal Mode):
  • Sample Size: Varies by analyte (e.g., N=490 for Hct, N=485 for COHb).
  • Data Provenance: Three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL. Heparinized whole blood patient samples from the intended use population. Samples spiked in CSL to cover reportable ranges. Provenance likely USA, prospective.
• Clinical Testing (Capillary Samples):
  • Sample Size: Native capillary samples: N=52 (external POC), N=100 (IL CSL) for a total of 152 native samples for O2Hb, HHb, sO2. Total N becomes 180-182 when pooled with additional internally prepared contrived capillary samples for specific analytes (pages 29-30).
  • Data Provenance: One external POC site and the IL internal Customer Simulation Laboratory (CSL). Native finger-stick samples and contrived capillary samples. Provenance likely USA, prospective.

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)

The document relates to an in-vitro diagnostic device measuring blood parameters. Ground truth in this context is typically established by comparative measurements against a recognized reference method or a predicate device, not by expert consensus in the same way an imaging AI would use expert radiologist reads.

For the Internal Method Comparison and Clinical Testing studies, the GEM Premier 5000 was compared to the predicate device, the GEM Premier 4000. The predicate device itself serves as the "reference standard" or "ground truth" for demonstrating substantial equivalence. The document does not specify human experts establishing ground truth for the test set; rather, the predicate device and established analytical methods (e.g., CNMetHb procedure - CLSI H15-A3 for tHb) are used as comparators.

The Linearity study also mentions comparing results to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)".

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of in-vitro diagnostic device. "Adjudication" typically refers to the process of resolving discrepancies between human readers or between human readers and an AI output, especially in imaging studies where subjective interpretation is involved. For this device, ground truth is established through quantitative comparisons against established reference methods or a predicate device.

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 an in-vitro diagnostic device that provides quantitative measurements of blood parameters, not an AI-based imaging or diagnostic aid that assists human readers/clinicians in interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.

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

Yes, the studies presented evaluate the performance of the device itself in a standalone capacity. The GEM Premier 5000 provides quantitative measurements directly. Operators interact with the device to load samples and retrieve results, but the analytical process and result generation are entirely performed by the instrument's internal "algorithm" (i.e., its measurement and data processing capabilities).

The device description on page 5 highlights its autonomy:

• "The analyzer guides operators through the sampling process with simple, clear messages and prompts."
• "After inserting the GEM PAK, the instrument will perform an automated PAK warm-up..."
• "Auto PAK Validation (APV) process is automatically completed..."
• "iQM2 manages the quality control process, replacing external quality controls."

This indicates that the device operates autonomously for its core measurements, with human intervention for sample loading and result review, but not for interpreting the raw measurement signals.

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

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The GEM Premier 4000 served as the primary comparator for method comparison studies, demonstrating substantial equivalence.
• Standard Reference Procedures/Analyzers: For linearity studies and potentially for other analytical performance aspects, comparison to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)" was used.
• Certified Control Materials: Aqueous controls and GEM PAK Process Control Solutions that are "traceable to NIST standards, CLSI procedures or internal standards" were used for precision and reproducibility studies. These materials have known, certified values which serve as ground truth for assessing device accuracy and precision.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary focus is on proving the analytical performance of an in-vitro diagnostic instrument through traditional analytical validation studies (precision, linearity, method comparison, etc.).

However, the device incorporates "Intelligent Quality Management 2 (iQM2)" which is described as "an active quality process control program designed to provide continuous monitoring of the analytical process... with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions." While iQM2 itself would have been developed and "trained" or calibrated using extensive internal data during the device's R&D phase, the public 510(k) summary does not provide details on a specific training set size for the iQM2 component. The studies presented are for the validation of the final device's performance, not the internal development of iQM2.

The "internal precision study" and "internal method comparison" are validation studies of the final device. The data shown in these tables is for testing the device's performance, not training it.

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

As noted in point 8, a "training set" in the context of typical AI/ML models is not explicitly described or relevant for the approval justification in this 510(k) summary. The document validates the measurement accuracy and precision of the device against predicate devices and reference methods, not an AI model that learns from data in the field.

If "training set" refers to the data used to initially calibrate the instrument's sensors and algorithms during development, this ground truth would have been established through:

• Primary Reference Methods: Employing highly accurate and precise laboratory methods (e.g., gas chromatography, certified spectrophotometric methods, gravimetric/volumetric methods) to determine the true concentration of analytes in reference materials and clinical samples.
• Reference Materials/Standards: Calibrating the device using NIST-traceable standards and other certified reference materials with known analyte concentrations.
• Extensive Internal Testing and Optimization: Using a large array of characterized samples (e.g., blood samples with varying analyte concentrations, interfering substances) to optimize the device's measurement algorithms and ensure accurate performance across its claimed reportable range.

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