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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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The intended use of the CRIT-SCAN II Monitor is as a continuous, non-invasive hematocrit-measuring device whereby a physician could use the information to determine the anemic state of the patient.
The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device.

The CRIT-SCAN II consists of state-of-the-art optoelectronics which, when combined with custom software, has the ability to measure hematocrit transcutaneously (i.e. through a patient's middle finger or index finger). The patient's finger is placed into a custom designed cuff which, when filled with air, creates the necessary perfusion for the optoelectronics to take a hematocrit reading.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 198 patients
• Data Provenance:
  • Country of Origin: United States (8 studies) and Sweden (1 study).
  • Retrospective or Prospective: The study design indicates a prospective data collection. Data was "gathered" between December 11th, 1997, and September 10th, 1998, with measurements taken non-invasively and blood samples drawn concurrently for comparison.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The ground truth (reference method) was stated as the Coulter Counter method, which is a laboratory instrument, not a human expert.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison was directly between the CRIT-SCAN II readings and the Coulter Counter readings, which serves as the established gold standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated monitor, and the study focused on its accuracy against a laboratory reference, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The CRIT-SCAN II is described as an automated device that provides a reading in less than 30 seconds. The comparison was solely between the device's output and the Coulter Counter's output, without human interpretation of the CRIT-SCAN II's raw data for diagnosis.

7. Type of Ground Truth Used

The ground truth used was a laboratory reference standard: the Coulter Counter method of hematocrit measurement. This is stated as a "highly accepted method of hematocrit measurement in the blood processing industry."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a separate training set. The descriptions of data collection appear to refer to the validation or test set. It mentions "IDC gathered data on 198 patients" for the purpose of the study detailed. It is possible that some internal data was used for development prior to this "final" study, but it's not specified here.

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

Since a distinct training set is not explicitly mentioned, the method for establishing ground truth for development or training would likely be the same as for the test set: comparison to the Coulter Counter method. However, this is an inference as the document focuses on the performance against the predicate.

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The StatProfile Ultra A,B,C,D and E Analyzers are intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Intended for Point-of-Care Usage

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "STAT Profile Ultra A, B, C, D, and E Analyzers". This letter approves the device for marketing based on substantial equivalence to a predicate device, but it does not contain the detailed study results or acceptance criteria for the device's performance.

Therefore, I cannot extract the information required to answer your questions from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical trial report, or the 510(k) submission itself, which would contain the performance data and study details.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General regulatory requirements for the manufacturer.
• The intended use of the device: "quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood."
• Mention of "Point-of-Care Usage".

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Automator 2000 has the control circuitry, drive components, and battery contained in a single housing. The compact and entirely self contained design of Automator 2000 simplifies the installation of the product. Automator 2000's machined aluminum housing is a robust design that comfortably accommodates the axial force and impact load requirements of the device. Additionally, the conductive aluminum housing has been designed to preclude radio frequency interference. Automator 2000's design has retained the CF Automator's redundant self diagnostic and circuitry controls to assure that the telescoping rod may move only the amount it is intended to move, and only when it is intended to move. Since each Automator 2000 device has its own control circuitry, the complexity built into the CF Automator circuitry for controlling multiple drive units has been removed. Since Automator 2000 is programmed using switches on the control board rather than through an IR communication link to a doctor's master computer, further communication circuitry has also been rendered unnecessary. Consequently, Automator 2000 has a more simplified circuit board and software package. Automator 2000 has 7 rate setting to chose from and the movement amount per increment is held constant at 1/360th mm. Both systems have been designed to use the final drive gear as an encoder to verify the position of the telescoping rod. Each system will error if the encoder does not verify that distraction is progressing within tolerable accuracy. Both systems check current on the motor circuit to verify the motor runs only when it is supposed to, and furthermore, check current during motor pulses to verify that current is not higher than expected, Both motor circuits have switches that remain open between motor pulses to prevent the motor from receiving current. Both systems use a watch-dog circuit to confirm software operation nearly continuously. Both systems have redundant audio and visual alarms. Furthermore, both units use the same design telescoping rod, which may be used to make manual lengthening adjustments at any time.

This FDA clearance letter (K981426) for the STAT Profile Ultra F, G, H, I, J, K and L Analyzers from Nova Biomedical, issued in 1998, primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria, nor does it describe AI-related performance or ground truth establishment.

The document is an FDA clearance letter for a medical device (analyzers), not a study report or clinical trial summary. Therefore, the requested information, which pertains to the detailed results of a performance study, is not present in the provided text.

Based on the provided text, I can only state what is not available:

1. A table of acceptance criteria and the reported device performance: Not present. The letter indicates the device is substantially equivalent but doesn't list performance metrics or criteria explicitly.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not present. This document predates widespread AI in medical devices, and no mention of AI is made.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Again, no mention of AI or algorithm-only performance.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The letter confirms the device's classification and substantial equivalence to pre-1976 marketed devices, allowing it to proceed to market under general controls. It also mentions potential CLIA complexity categorization and refers to regulations like GMP.

The second part of the provided text, discussing "Automator 2000" and "CF Automator," describes a different device in terms of its mechanical, housing, circuitry, and software design improvements over a predicate. This section also does not discuss acceptance criteria or study results for performance metrics. It focuses on design changes for a device that appears to be related to an external fixator/telescoping rod system, which is different from the "STAT Profile Ultra F, G, H, I, J, K and L Analyzers" mentioned in the FDA letter.

Therefore, I cannot fulfill the request as the necessary information for acceptance criteria and study details is not contained within the provided text.

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The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Intended for Point-of-Care Usage

Not Found

This document is a marketing clearance letter from the FDA for a device called "STAT Profile M Analyzer," not a study report. It does not contain information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This substantial equivalence determination is based on the information provided in the 510(k) premarket notification, but the letter itself does not detail the specific performance studies, acceptance criteria, or their quantitative results.

Therefore, I cannot provide answers to the requested information based on the provided text, as the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information about experts used to establish ground truth.
4. Adjudication methods.
5. Details of a multi-reader multi-case comparative effectiveness study or effect sizes.
6. Results of a standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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