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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, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. 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. Iiver 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.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is 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, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.

As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

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, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. 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. Iiver 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.

Software V3.0.0 introduces the following new functionality to further improve the service and support of the GEM® Premier 4000: Remote desktop sharing, Remote software upgrades, Remote diagnostics, Remote LIS tracing, Remote cartridge data (Copy IL Data) transfer.

Here's an analysis of the provided text regarding the GEM® Premier 4000 device, focusing on the acceptance criteria and study information:

Key Finding: This submission (K133407) is a Special 510(k) for a software modification only. It asserts that the modifications have no impact on the performance of the device and therefore, the performance data from the predicate device (K112995) still applies. As such, the document does not contain new acceptance criteria or new study data to demonstrate the device meets acceptance criteria for its analytical performance. It focuses on the verification and validation of the new software features.

Given this, I will extract information related to the device's original performance as described, but it's important to note that this document doesn't provide new studies for analytical performance.

Acceptance Criteria and Device Performance (Based on Predicate Device K112995)

Since this K133407 submission is a modification of a previously cleared device (K112995) and claims "Identical Performance Characteristics" and that the software changes "have no impact to the performance," the acceptance criteria and reported device performance are implicitly those established and accepted for the predicate device. However, this document does not explicitly list performance acceptance criteria or detailed performance reports for the analytes.

The document states:

• "The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements." This indicates that IL (Instrumentation Laboratory) has internal specifications that must be met for quality control (GEM CVP) to ensure accuracy.

Therefore, a table of acceptance criteria and reported device performance for the analytes cannot be fully created from this document. The document specifically states that "the performance data on record for the predicate device (K112995) still apply." To find the detailed acceptance criteria and performance, one would need to refer to the K112995 submission.

Study Details (for the K133407 Software Modification)

This special 510(k) focuses on the software modification and its impact, not on the analytical performance of the device.

1. Sample size used for the test set and the data provenance:

   • Test set for analytical performance: Not applicable for this submission, as full analytical performance studies were not conducted. The submission states that the software changes have no impact on analytical performance, so the performance data of the predicate device (K112995) is referenced.
   • Test set for software verification/validation: The document mentions "design control principles (risk management, verification and validation) have been applied," but it does not specify sample sizes or data provenance for the software testing.

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

   • Not applicable for a software modification submission. No human expert "ground truth" was established for analytical performance in this specific document.

3. Adjudication method for the test set:

   • Not applicable.

4. 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 device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

   • The "standalone" performance of the analytical functions refers to the predicate device K112995. This submission K133407 focuses on software features (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) that improve service and support, not the core analytical algorithm's standalone performance.

6. The type of ground truth used:

   • For the analytical performance (referenced from K112995), the ground truth for blood gas, electrolyte, and metabolite measurements in IVDs typically involves reference methods, calibrated standards, or comparative studies against established laboratory instruments using patient samples. This document does not specify the type of ground truth used for the original analytical performance.
   • For the software modifications in this K133407, the ground truth would be adherence to functional and non-functional requirements established during the software development and verification process.

7. The sample size for the training set:

   • Not applicable. This is an IVD device, not a machine learning model that requires a training set in the AI sense.

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

   • Not applicable.

Summary of what's provided for K133407:

This document is a "Special 510(k)" for a software update (V3.0.0) to the GEM® Premier 4000. The primary claim is that the software changes (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) do not impact the fundamental scientific technology or performance characteristics of the device. Therefore, no new analytical performance studies were conducted, and the previous performance data (from K112995) still applies. The document emphasizes that "design control principles (risk management, verification and validation)" were applied to ensure the software release's safety and effectiveness, but it does not provide details on the specific testing performed for these software features (e.g., sample sizes of test cases, specific test protocols, or acceptance criteria for the software functions themselves).

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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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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.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is 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, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.

As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

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

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

GEM Premier 4000 - Introductions / Modifications:

• Addition of total bilirubin (tBili) measurement with whole blood and heparinized plasma on the GEM Premier 4000 performed using spectrophotometric multi-component analysis through the instrument's existing CO-Oximetry module. Following the electrochemical measurements for blood gases, electrolytes and metabolites, a portion of the sample is chemically hemolyzed and brought into an optical cell for the CO-Oximetry measurements and the additional total bilirubin measurement. There were no hardware or mechanical changes required, and no changes to the reagent cartridge (PAK) formulation or sensors. The measurement of total bilirubin was implemented through software.
• Expansion of the low-end reportable range for total hemoglobin (tHb) parameter from 5 g/dL to 3 g/dL through additional testing.
• Addition of a new 100 uL sample size for total bilirubin and CO-Oximetry mode only.
• Automation of fetal hemoglobin correction for CO-Oximetry. Previously the user would input the age of the patient to apply the correction. The new software applies the correction automatically based on the presence of fetal hemoglobin in the sample without user input.
• GEM CVP 2 with CO-Ox: This currently marketed external solution for the GEM Premier 4000 will also be value assigned for total bilirubin. No change in formulation.
• GEM CVP 5 tBili: An additional external solution for the GEM Premier 4000, containing purified human hemoglobin, stabilizers and biocide in a physiologically buffered matrix, is being introduced at another level of total bilirubin.
• GEM System Evaluator: Three-level aqueous buffered bicarbonate solution intended for use with the GEM Premier 4000 analyzer, containing inorganic salts and organic metabolites, dye and biocides; equilibrated with carbon dioxide and oxygen.
• GEM Hematocrit Evaluator: Three-level aqueous buffered bicarbonate solution intended for use with the GEM Premier 4000 analyzer, containing inorganic salts and biocides; equilibrated with carbon dioxide and oxygen.

Here's a breakdown of the acceptance criteria and study information for the GEM Premier 4000 with iQM, focusing on the total bilirubin (tBili) measurement, based on the provided 510(k) summary:

The document is a 510(k) summary for a medical device. These summaries typically do not contain the full details of clinical studies with extensive data on sample sizes, expert qualifications, or detailed statistical analyses that would be found in a full submission or peer-reviewed publication. Instead, they focus on demonstrating "substantial equivalence" to predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes differences and similarities to predicate devices and states that "data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence... Equivalence is demonstrated through imprecision, method comparison, interference, sample matrix and stability studies, along with software development information."

However, it does provide information about the Tested Range for total bilirubin measurement, which can be seen as an informal performance characteristic:

The "acceptance criteria" for the new device appear to be that its performance characteristics (imprecision, method comparison, interference, sample matrix, stability) are substantially equivalent to the predicate devices, and its claimed detection range (0.3 to 40.0 mg/dL) is within acceptable clinical limits and potentially an improvement over the predicate's range.

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

The 510(k) summary does not provide details on specific sample sizes used for the various tests (imprecision, method comparison, interference, sample matrix, stability studies). It only states that these studies were performed as part of the Premarket Notification.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, safety and effectiveness studies for 510(k) submissions are typically conducted by the manufacturer, often at their own facilities or contracted labs, using in-house developed protocols. Given the nature of a 510(k) for a laboratory instrument, the data would likely be prospective testing performed specifically for the submission.

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

This type of information is not provided in the 510(k) summary. For a device like a blood gas analyzer measuring total bilirubin, the "ground truth" for method comparison and accuracy studies would typically be established by comparing against a reference method (e.g., a highly accurate laboratory method) rather than human experts interpreting images or clinical cases.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are usually relevant for studies where human expert disagreement on a qualitative assessment (e.g., image interpretation) needs to be resolved. This is not applicable to the type of analytical performance studies described for this device, which focuses on quantitative measurements.

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

No MRMC comparative effectiveness study was done or is applicable to this device. An MRMC study is relevant for evaluating diagnostic aids that assist human readers in making interpretations (e.g., radiologists interpreting images). This device is an automated in vitro diagnostic instrument that provides quantitative measurements, not an AI assistant for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device, the GEM Premier 4000 with iQM for total bilirubin measurement, is a standalone algorithm/instrument. Its performance is its standalone performance. The measurements it provides are direct outputs from the instrument's spectrophotometric analysis. The iQM system is an internal quality control system that functions automatically without human intervention for real-time error detection and correction.

7. Type of Ground Truth Used

For analytical performance studies of quantitative in vitro diagnostic devices like this one, the "ground truth" (or reference method) is typically:

• Reference method comparison: A recognized, highly accurate, and precise analytical method (e.g., a laboratory gold standard method like a direct spectrophotometric method or HPLC for bilirubin) with known accuracy and traceability.
• Known concentration samples: Using materials with certified or precisely known concentrations (e.g., calibrators, certified reference materials, spiked samples) for accuracy and linearity.

The summary indicates "method comparison" studies were performed. This implies comparison against another established analytical method.

8. Sample Size for the Training Set

No "training set" information is provided, nor is it directly applicable in the conventional sense of machine learning for image analysis. This device is a spectrophotometric analyzer, not a machine learning model that learns from large datasets of labeled cases in the same way typical AI/ML medical devices do. The software implements the measurement algorithm, and its "training" would be more akin to algorithm development and calibration, using controlled samples with known values.

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

As noted above, a "training set" in the machine learning sense is not applicable here. The analytical algorithms and instrument calibration would be developed and verified using:

• Known chemical standards: Solutions with precisely measured concentrations of the analytes.
• Calibrators: Materials specifically designed to calibrate the instrument to known values.
• Reference methods: Comparisons against established, highly accurate analytical techniques to ensure the instrument's measurements are correct.

This information would be part of the instrument's design validation and verification, not typically detailed as a "training set ground truth" in a 510(k) summary.

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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, Na+, K+, Cl-, Ca++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. 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.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is 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, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

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, Na . K , CI , Ca * , glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. 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.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iOM is 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, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartidge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

The provided text focuses on the 510(k) summary for the GEM Premier 4000 with iQM and GEM CVP. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way you've requested (e.g., specific sensitivity/specificity values, error rates, or statistical comparisons of performance benchmarks).

The document primarily states:

• "In-house and field site testing supports that the GEM Premier 4000 with iOM in conjunction with GEM CVP 1 and 2 with CO-Ox and GEM CVP 3 and 4 Hematocrit is not materially different from the above listed predicate devices in performance, safety and effectiveness or intended use."

This indicates that studies were performed to demonstrate substantial equivalence, but the details of those studies, including acceptance criteria and results, are not provided in this 510(k) summary. These details would typically be found in the full 510(k) submission, which is not publicly accessible in its entirety.

Therefore, I cannot populate the table or answer most of your specific questions based on the information provided. I can only report what is explicitly stated in the document.

Here's what can be extracted based on the provided text, and where information is missing:

Acceptance Criteria and Device Performance

The document does not provide a table of explicit acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each analyte. It broadly states that the device is "not materially different" in performance from predicate devices, which is the basis for 510(k) clearance.

Study Information (Based on available text):

1. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "In-house and field site testing" but does not give sample sizes, country of origin, or whether data was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
4. 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 device is an automated in vitro diagnostic analyzer, not an AI-assisted imaging or diagnostic tool for human readers. It measures biochemical parameters directly.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device (GEM Premier 4000) itself performs the analysis automatically. The iQM system 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, replacing the use of traditional external quality controls." This implies standalone operation in terms of analytical performance. The external CVP solutions are for calibration verification.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for in vitro diagnostic devices measuring analytes, ground truth is typically established by reference methods or validated laboratory methods.
7. The sample size for the training set: Not applicable/specified. This is an analytical device, not a machine learning model that typically has a distinct "training set" in the sense of AI/ML. The internal iQM system learns/monitors from its ongoing operations and calibrations rather than a separate training set.
8. How the ground truth for the training set was established: Not applicable/specified (see point 7).

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