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The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM Premier 3000 device, formatted to answer your questions.

It's important to note that this document is a 510(k) summary for a special FDA submission, specifically for an operating system update. Therefore, the details about original device validation and comprehensive performance studies might be summarized or assumed to be met from the predicate device.

Acceptance Criteria and Study for GEM Premier 3000 (Software V6.3.0 Update)

This submission describes an update to the GEM Premier 3000 device's software (V6.3.0) and operating system (Linux Fedora Core 21) due to component obsolescence. The primary focus of the provided text is to demonstrate that these changes do not alter the previously established performance and safety of the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "No change to labeled performance claims." This indicates that the performance criteria for the updated device are identical to those of the predicate device (GEM Premier 3000, K052121), which was already cleared by the FDA. The submission's goal is to prove that the software/OS update maintains these pre-existing performance claims.

Therefore, the acceptance criteria are not new performance metrics but rather the demonstration that the updated device performs equivalently to the predicate device across all its established parameters. The "reported device performance" in this context refers to the verification and validation activities showing that the device continues to meet those original, unlabeled performance claims.

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

The document details software verification and validation activities. However, it does not specify a particular sample size for a "test set" in terms of patient samples or clinical data from a specific geographic region. The testing appears to be focused on software functionality and its impact on performance rather than a new clinical study with patient samples.

• Sample Size: Not explicitly stated for testing of the updated software/OS in a clinical or laboratory setting with a defined number of cases. The testing appears to be centered on software function verification and validation.
• Data Provenance: Not specified. Given it's a software/OS update, the "data" would primarily be software test results rather than patient data. The original predicate device presumably had data provenance established during its clearance.
• Retrospective/Prospective: Not applicable to the software/OS update described.

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

This information is not provided in the document. The nature of this submission (a Special 510(k) for an OS update) means that new ground truth establishment by external experts for device performance is likely not required, as the performance claims are carried over from the predicate device. The verification and validation would be internal engineering and quality assurance activities.

4. Adjudication Method for the Test Set

This information is not provided and is unlikely to be relevant for a software/OS update focused on maintaining equivalence to a predicate device's performance. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that requires consensus for ground truth.

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

No, an MRMC comparative effectiveness study was not done. This device is an analyzer for blood samples, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, the concept of "human readers improve with AI" does not apply here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself, the GEM Premier 3000, is a standalone instrument that provides quantitative measurements. The update discussed here is for its internal operating system and software. The "standalone" performance for the measurements is inherent to the device's function, and the submission's purpose is to confirm this performance is maintained after the software/OS update. It is not an AI algorithm in the typical sense.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the original predicate device's performance, the ground truth for parameters like pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct would typically be established through reference methods (e.g., highly accurate laboratory methods, calibrated standards). The current submission relies on the established performance of the predicate device, implying that the ground truth for its performance was originally established via these reference methods and that the updated device continues to align with those.

The "ground truth" for the software update itself is that the software performs its functions correctly and reliably, and that no regression or new hazards are introduced. This is verified through software testing against design specifications.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The GEM Premier 3000 is a measurement device, not a machine learning or AI algorithm that requires a "training set" in the context of developing a diagnostic model. The software update is for an operating system and application software, not for an AI model.

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

This information is not applicable as there is no "training set" in the context of this device and its software update.

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The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting that was originally cleared for the U.S. market under K992834, with glucose and lactate parameters added under K010520 and Intelligent Quality Management (iQM) introduced under K022158. The reportable ranges for the Glucose and Lactate parameters are being extended through additional performance testing with the release of a new software version.

The provided text describes an extension of the reportable ranges for Glucose and Lactate parameters on the GEM Premier 3000 device. The study to prove this involved linearity data and detection limit testing.

Here's the information extracted and organized:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for extending the reportable ranges were based on achieving satisfactory linearity as demonstrated by the slope, intercept, and R-squared values from linearity testing. Specific numerical acceptance criteria for these metrics are not explicitly stated as target values, but the reported values indicate the device meets the linearity and detection limit requirements for the extended ranges.

Note: The "Acceptance Criteria" column is inferred from the statement that the reportable ranges were extended based on the provided data, implying these performance metrics met the necessary thresholds.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Glucose: 30-32 samples per level
  • Lactate: 32-33 samples per level
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be an internal performance evaluation for regulatory submission, likely conducted in a controlled lab setting, which could be considered prospective in nature for new range validation.

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

Not applicable. The study is a performance validation for an in vitro diagnostic device, specifically focusing on linearity and detection limits. Ground truth is established by the known concentrations of calibrators or reference materials used for the linearity testing, not by expert interpretation.

4. Adjudication method for the test set

Not applicable. This type of study does not involve adjudication as it's a technical performance validation against quantitative standards, not qualitative assessments requiring expert consensus.

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 a 510(k) summary for an in vitro diagnostic device measuring blood analytes, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone performance study was done. The reported "Performance Data Summary" outlines the linearity of the device's measurements for Glucose and Lactate, which directly reflects the algorithm's (or device's) ability to accurately quantify these parameters across the extended ranges. The study focuses on the device's inherent measurement capabilities.

7. The type of ground truth used

The ground truth for the linearity testing would be the known concentrations of reference materials or calibrators spanning the reportable range. These are precisely prepared solutions with verified analyte concentrations. For Lactate, it's mentioned that samples were "stabilized through repeated washing and icing in vitro for testing," indicating controlled preparation to achieve specific concentrations.

8. The sample size for the training set

Not applicable. This device is not described as utilizing a machine learning algorithm that requires a separate training set. The performance validation is based on direct measurement principles.

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

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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The GEM® Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520.

Intelligent Quality Management (iQM") is being introduced on the GEM® Premier 3000 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.

As part of this program, GEM® CVP (Calibration Validation Product) is intended for the external verification of the iQM" cartridge calibration after initial warm-up to ensure its integrity. The reported values for the four levels of GEM® CVP (two levels for pH, blood gases, electrolytes and metabolites; 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 iOM "program monitors the status of the system during the cartridge use life.

To ensure that a total quality management system is adhered to, laboratories should follow local, state and federal regulatory guidelines. As with any analytical device or computer software, there is always the potential for software failure. However, IL conducts rigorous testing and extensive software validation prior to releasing a software revision. If the user encounters a rare software error code, it should be reported to your local IL Technical Support Representative.

The GEM® Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples that was originally cleared for the U.S. market by K992834, with glucose and lactate parameters added by K010520.

Intelligent Quality Management (iQM") is being introduced on the GEM® Premier 3000 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.

As part of this program, GEM® CVP (Calibration Validation Product) is intended for the external verification of the iQM" cartridge calibration after initial warm-up to ensure its integrity. The reported values for the four levels of GEM® CVP (two levels for pH, blood gases, electrolytes and metabolites; 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 iOM "program monitors the status of the system during the cartridge use life.

Here's a breakdown of the acceptance criteria and the studies performed for the GEM® Premier 3000 with iQM™ and GEM® CVP, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it presents the results of performance studies (precision and method comparison) that indicate the device's capabilities and statistical similarity to a reference instrument.

For the GEM® CVP Precision study, the reported performance is the Day-to-Day %CV (or SD) and Total %CV (or SD) for various parameters across different CVP levels. The acceptance is implicitly assumed if these values are considered acceptable for clinical use, or comparable to existing methods.

For the GEM® Premier 3000 with iQM™ Method Comparison study, the reported performance includes the slope, intercept, and correlation coefficient (r) when compared to a reference instrument (IL Synthesis). The acceptance is stated as being "statistically similar to the reference instrument."

Table of Reported Performance Data (Excerpted from the document):

GEM® CVP Precision Study Results:

GEM® Premier 3000 with iQM™ Method Comparison Study Results:

Study Information:

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

• GEM® CVP Precision Study:

  • Test Set Size: 15 replicates for each of 4 CVP levels on each of 9 different GEM® Premier 3000 instruments (N=135 total measurements per CVP level/parameter combination).
  • Data Provenance: Not explicitly stated, but implied to be from internal lab studies. It's likely a controlled, prospective study.

• GEM® Premier 3000 with iQM™ Method Comparison Study:

  • Test Set Size (N): Varies per analyte, ranging from 271 to 284 samples (e.g., 281 for pH, 282 for pCO2, 271 for Na+, etc.).
  • Data Provenance: "arterial, venous, heart bypass and liver transplant blood samples from hospital patients." This indicates human patient samples. The country of origin is not specified, but the submission is for the U.S. market, so it typically implies U.S. data or data relevant to its approval. It's a retrospective analysis of prospectively collected patient samples, as they were analyzed on both the test device and a reference instrument.

• iQM™ (Intelligent Quality Management) Evaluation - Evaluation of Cartridge Malfunction Detection:

  • Test Set Size: Data from 79 GEM® Premier 3000 cartridges that demonstrated a QC failure.
  • Data Provenance: Not explicitly stated, but implies real-world usage data where QC failures occurred. This would be considered retrospective analysis of field data.

• Field Evaluation: External QC vs. iQM™:

  • Test Set Size: 304 blood samples.
  • Data Provenance: During an external field evaluation at a U.S. hospital. This is prospective real-world data collection.

2. 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 describes device performance validation against instrument measurements and quality control materials. It does not involve human expert interpretation of results to establish ground truth in the way a medical imaging study might.
• GEM® CVP Precision: Ground truth is the actual concentration of the assayed quality control materials.
• GEM® Premier 3000 with iQM™ Method Comparison: Ground truth is established by the IL Synthesis reference instrument. No human experts are mentioned for establishing ground truth directly for this comparison.
• iQM™ (Intelligent Quality Management) Evaluation: Ground truth for a malfunction detection study would be the confirmed presence or absence of a malfunction in the cartridge. This was determined by analysis of "system parameters" and the nature of the QC failures. "No identifiable cartridge malfunction" and "All system parameters were within specifications" implies instrument-derived ground truth.
• Field Evaluation: Ground truth for analyte failures came from the observation of "transient drift failures," "Benzalkonium exposure," and "Thiopental Sodium exposure."

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

• Adjudication methods like 2+1 or 3+1 are typically used when human interpretation (e.g., by experts) is involved to resolve discrepancies in ground truth establishment. Since these studies primarily involve comparing instrument readings or detecting malfunctions based on predefined parameters, no such adjudication method is mentioned or appears 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

• No MRMC comparative effectiveness study was done. This device is an analytical instrument and an associated quality control program, not a diagnostic aid that assists human readers in interpreting images or complex data as in AI applications. The focus is on automated measurement accuracy and malfunction detection.

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

• Yes, the performance of the GEM® Premier 3000 with iQM™ and GEM® CVP is evaluated entirely in a standalone manner. The iQM™ system itself 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." Its evaluation, therefore, is its performance as a standalone automated system. The studies assess its precision, agreement with a reference instrument, and its ability to detect malfunctions automatically.

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

• GEM® CVP Precision: Assayed values of the quality control materials.
• GEM® Premier 3000 with iQM™ Method Comparison: Readings from a reference analytical instrument (IL Synthesis).
• iQM™ (Intelligent Quality Management) Evaluation - Evaluation of Cartridge Malfunction Detection: Instrument-based parameters and previous QC failure data. The conclusion that "no identifiable cartridge malfunction" existed for the unflagged failures suggests thorough investigation of instrument internal states.
• Field Evaluation: Identified causes of analytical interference (Benzalkonium exposure, Thiopental Sodium exposure) and comparison to a reference instrument (IL Synthesis) and a GEM® 3000 without iQM.

7. The sample size for the training set

• The document does not explicitly state the sample size for a "training set." This type of device relies on established analytical principles and algorithms. While the iQM™ system uses "Failure Pattern Recognition (FPR) checks," it's not described as a system that undergoes machine learning training in the contemporary sense. The "training" in this context would likely refer to internal development and validation data, not a distinct "training set" as in typical AI/ML development. The "79 GEM® Premier 3000 cartridges that demonstrated a QC failure" were part of an evaluation to test the FPR checks, not necessarily to train them.

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

• As a conventional analytical instrument and its QC system, there isn't a "training set" with ground truth established in the same way as an AI/ML model for image recognition or diagnosis. The underlying principles for analysis and quality control are based on established chemistry, physics, and engineering. The "ground truth" for the device's operational parameters would have been established through extensive engineering, chemical assays, and calibration procedures during the device's development.

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The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH. pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the GEM Premier 3000 device:

Acceptance Criteria and Device Performance for GEM Premier 3000

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for precision and method comparison. Instead, it presents the results of the studies and implicitly suggests that these results were deemed acceptable by the FDA for substantial equivalence. The predicate device (IL Synthesis and manual spun hematocrit) serves as the de facto acceptance benchmark.

Below are the reported performance metrics from the studies:

Precision Data (Combined Within Run and Total %CV / SD)

Method Comparison Data (GEM Premier 3000 vs. Predicate Device)

Based on the FDA's decision to clear the device (K992834), the reported precision and method comparison results for the GEM Premier 3000 were considered sufficient to demonstrate substantial equivalence to the predicate devices. The implicit acceptance criteria were therefore met.

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

Precision Study:

• Sample Size: 60 replicates (4 per day for 14 days, twice on Day 1) on each of 7 different IL GEM 3000 instruments, totaling 420 replicates for each parameter at each control level.
• Data Provenance: The data was generated using "three levels of controls (GEM Check Plus) for pH, pCO2, pO3, Na+, K+, Ca++ and two levels of controls (GEM critCheck) for hematocrit." It is an in-vitro study using manufactured control materials. The country of origin is not explicitly stated but implies a controlled laboratory setting.

Method Comparison Study:

• Sample Size:
  • pH, pCO₂, pO₂: n = 128-130
  • Na+, K+, Ca++: n = 80-85
  • Hct: n = 117
• Data Provenance: The samples were from "arterial, venous, heart bypass and liver transplant blood samples from hospital patients using heparinized syringes and from healthy volunteers using heparinized vacutainer tubes." This indicates a prospective collection of human whole blood samples in a clinical setting. The country of origin for the hospital patients and healthy volunteers is not specified, but it's likely within the US given the FDA submission.

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

This type of device (blood gas analyzer) does not typically involve human "experts" to establish ground truth in the same way an imaging or diagnostic AI device does. The ground truth for the method comparison study was established by measurements from the predicate devices:

• For pH, pCO2, pO2, Na+, K+, and Ca++: the IL Synthesis (an existing, legally marketed blood gas analyzer).
• For Hct: manual spun hematocrit (a standard laboratory method).

No specific "experts" with defined qualifications were involved in establishing the ground truth beyond the inherent calibration and standard operating procedures of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations (e.g., by multiple readers). The "ground truth" was obtained through direct measurements from the 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. The GEM Premier 3000 is an automated blood gas analyzer, not an AI-powered diagnostic tool that assists human readers/interpreters in a multi-reader, multi-case study context. It directly measures and reports values.

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

Yes, in essence, the entire performance evaluation is a "standalone" assessment of the device's accuracy and precision. The GEM Premier 3000 operates as an automated system; its outputs are the direct measurements it provides. The method comparison study compares its standalone performance against established analytical methods (predicate devices), and the precision study evaluates its inherent measurement variability.

7. The Type of Ground Truth Used

The ground truth used for the method comparison study was comparative measurements from a legally marketed predicate device (IL Synthesis) and a standard laboratory method (manual spun hematocrit). This constitutes an established reference method or reference standard for the parameters being measured in the clinical laboratory context.

8. The Sample Size for the Training Set

Not applicable. The GEM Premier 3000 is a physical medical device (an analyzer) and not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its underlying hardware and software are designed and validated through engineering processes, not by statistical training on a dataset.

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

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design, manufacturing standards, and internal validation, not through a data-driven training process.

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