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The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, urea (BUN), total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, sodium, potassium, ionized calcium, choride. glucose and urea (BUN) of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses scattering for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.

The provided text describes the AVL OPTI Critical Care Analyzer, focusing on its substantial equivalence to other marketed devices and its technological characteristics. However, it does not explicitly state specific acceptance criteria (e.g., performance thresholds like "accuracy must be within X%") in a table format, nor does it provide a detailed study that proves the device meets such criteria with quantitative results in the way you've requested.

Instead, the document focuses on:

• Demonstrating substantial equivalence: By comparing the AVL OPTI to existing devices and stating that there was "no significant difference in mean values (P<0.05) obtained on measurement by the AVL OPTI from those of the predicate devices."
• Confirming compliance with standards: Mentioning EN 50081-1, FCC Class B, EN 50081-2, and IEC 1010-1.
• General testing methods: Describing how precision, linearity, and interferences were evaluated.

Given this, I cannot fully complete all sections of your request as the specific quantitative acceptance criteria and detailed study results (like sample sizes for test sets, experts, adjudication methods, effect sizes, standalone performance, and training set details) are not explicitly present in the provided text.

However, I can extract the available information and structure it as per your request, indicating where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated. The document mentions "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and plasma collected for routine analysis on existing instrumentation." It does not provide the number of patient specimens or samples.
• Data Provenance: Retrospective, using "remnant from patient specimens... collected for routine analysis on existing instrumentation." Country of origin is not specified, but the submission is to the US FDA, implying clinical relevance to the US.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states "operated by personnel trained to perform and report these analyses," which refers to the clinical personnel using the device, not experts establishing ground truth for comparisons. Ground truth seems to be established by comparison to predicate devices, not by expert review of complex images or interpretations.

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

• Adjudication Method: Not specified. The comparison relies on statistical analysis of mean values against predicate devices rather than human adjudication of agreement.

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

• MRMC Study: No, this device is a standalone analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

• Standalone Performance: Yes, the device itself is a standalone analyzer. The performance described (precision, linearity, comparisons to predicate devices) represents the device's standalone analytical capabilities.

7. The type of ground truth used

• Ground Truth Type: Comparison to predicate devices (other commercially available and legally marketed 'Combi Analyzers' and 'Point of Care' analyzers) served as the primary "ground truth" for demonstrating substantial equivalence. Additionally, "reference materials or methods" were used for linearity, and "N.I.S.T. traceable pH buffers" for pH standardization.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not specified. The document describes a "new device" that is an "improved design" of an existing AVL OPTI 1 pH/Blood Gas Analyzer. The testing described focuses on verification and validation of the new device's performance, not the training of a machine learning model.

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

• Ground Truth for Training Set: Not applicable/not specified, as this is not an AI/ML device that requires a training set in the conventional sense. The device's operation is based on established fluorescence optode technology and optical scattering, calibrated against known standards and verified through traditional analytic methods.

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The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb, SulfHb and metabolites; glucose, lactate and urea nitrogen in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.

The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 17 tests per sample.

Here's a breakdown of the acceptance criteria and study information for the AVL OMNI™ Modular Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it implicitly defines acceptance through the concept of "substantial equivalence" to predicate devices and the demonstration of "no significant difference in mean values" and "correlation" during clinical trials. The "reported device performance" is largely described qualitatively.

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

• Sample Size (Clinical Tests): Specimens were "remnant from patient specimens of both whole blood and serum or plasma collected for routine analysis on existing instrumentation." Patient populations included "extreme ranges of clinical values." The total number of patient specimens or individual data points is not specified.
• Sample Size (Non-Clinical Tests):
  • Precision: "samples of each of the specimen types suitable for measurement on the AVL OMNI™." The number of runs or samples is not specified.
  • Linearity in Aqueous Solutions: "Each of three AVL OMNI™ units" were used, with serially diluted solutions. The number of measurements or dilution series is not specified.
  • Linearity in Serum: "two AVL OMNI™ instruments" were used, with patient-sample pools mixed in varying ratios. The number of samples or ratios is not specified.
• Data Provenance: The data is retrospective, as it used "remnant from patient specimens... collected for routine analysis on existing instrumentation." The country of origin is not specified, but given the submitter's address in Roswell, GA, USA, it's likely primarily US-based, though this is an assumption.

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

The document states that "personnel trained to perform and report these analyses" operated the devices in the clinical setting. It does not mention a specific number of experts used for ground truth establishment or their qualifications (e.g., radiologist with X years of experience). The ground truth for the clinical correlation studies appears to be the results obtained from the legally marketed predicate devices.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison was directly between the AVL OMNI™ and the predicate devices, with statistical analysis ("no significant difference in mean values (P<0.05)").

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

This section is not applicable. The device described is an automated analyzer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

This section is applicable. The AVL OMNI™ Modular Analyzer is described as a "fully-automatic, microprocessor-controlled system" that performs measurements. The clinical and non-clinical tests described are evaluations of this standalone algorithm/device performance against predicate devices and established testing methodologies (precision, linearity, interferences).

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

The primary ground truth used in the clinical correlation studies was the measurements obtained from legally marketed predicate devices. For non-clinical tests like linearity in aqueous solutions, the "ground truth" was the gravimetrically prepared standards with known values.

8. The Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic (IVD) device (a laboratory analyzer), not a machine learning/AI device that would typically have a distinct "training set" in the common sense. Therefore, no sample size for a training set is specified. The device is based on established principles of measurement (potentiometric, amperometric, photometric, spectrophotometric, conductance) rather than being trained on a large dataset.

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

As explained in point 8, the concept of a "training set" for this type of device is not directly applicable. The device's principles of operation are based on validated chemical and physical measurement techniques, not on learning from a labeled dataset. Therefore, this information is not provided nor relevant in the context of this device's submission.

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The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, SO2, Na', K', Cl' and Ca* in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

For Professional Use Only
For In Vitro Diagnostic Use

The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in. 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and choride of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.

Here's a breakdown of the acceptance criteria and study information for the AVL OPTI Critical Care Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for precision, linearity, or interference. Instead, it describes compliance through comparative studies and general statements of no significant difference. Here's a summary of the reported performance:

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

• Sample Size: The document does not specify the exact sample sizes used for the precision, linearity, interference, or clinical correlation tests. It mentions "samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution" for precision and "remnant from patient specimens of both whole blood collected for routine analysis on existing instrumentation" for clinical tests.
• Data Provenance: The data appears to be prospective for the clinical tests, as it uses "remnant from patient specimens... collected for routine analysis." The country of origin is not explicitly stated, but given the submitter's address (Roswell, GA) and the FDA submission, it implicitly refers to studies conducted in the United States or under US regulatory guidelines.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For the clinical correlation study, the comparison was made against "predicate devices" operated by "personnel trained to perform and report these analyses." The AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers was used for linearity of pH as a reference method.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The clinical evaluation involved direct comparison to predicate devices, and the statistical analysis focused on the "mean values (P<0.05)."

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 involving human readers with and without AI assistance was not done. The device is an automated critical care analyzer, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

Yes, the studies described are essentially standalone performance evaluations of the AVL OPTI Critical Care Analyzer. It is an automated instrument that directly measures analytes, and the studies assess its precision, linearity, interference, and agreement with predicate devices without human interpretation as part of its core function.

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

The ground truth for the performance evaluations primarily involved:

• Reference Materials/Methods: For linearity, this included "reference materials or methods" and specifically an "AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers."
• Predicate Devices: For clinical correlation, the ground truth was established by the measurements from "predicate devices" (e.g., NOVA Biomedical STAT 5, Chiron 865, AVL 995, etc.).
• Quality Control Solutions: For precision, "aqueous quality control solution" was used.

8. The Sample Size for the Training Set

The document does not mention any "training set" or "training data" in the context of machine learning or AI. This device is an automated analyzer based on optical fluorescence and reflectance, not a machine learning model that requires a training set.

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

As there is no mention of a "training set" or a machine learning component for this device, this question is not applicable.

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The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in samples of whole blood, serum, and plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium and potassium of whole blood, plasma or serum as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 7 tests on a single sample, determined by the type of disposable cassette used.

The AVL OPTI Critical Care Analyzer is a medical device intended for measuring pH, PCO2, PO2, sodium, potassium, total hemoglobin content, and oxygen saturation in blood, serum, and plasma samples. The device uses optical fluorescence for some measurements and optical reflectance for others.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "In all evaluations, there was no significant difference in mean values ( P<0.05) obtained on measurement by the AVL OPTI." This serves as the primary acceptance criterion and the reported performance.

While specific percentage or numerical thresholds for accuracy or precision are not provided as acceptance criteria in this summary, the following non-clinical tests were conducted to establish performance:

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

• Sample Size for Test Set: Not explicitly stated with a specific number. The text mentions "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and serum collected for routing analysis on existing instrumentation." This implies a varied and likely significant number of patient samples.
• Data Provenance: The data is described as "remnant from patient specimens... collected for routing analysis on existing instrumentation." This indicates the data is retrospective and derived from actual patient samples. The country of origin of the data is not explicitly stated, but the submitter's address is Roswell, GA, USA, suggesting the studies were likely conducted in the US.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth was established by "predicate devices" and "reference materials or methods" (for linearity). The clinical testing was performed by "personnel trained to perform and report these analyses," implying qualified laboratory or healthcare professionals.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly mentioned. The comparison was made against predicate devices, with the conclusion being "no significant difference in mean values (P<0.05)." This suggests a statistical comparison rather than an expert adjudication process in the traditional sense of resolving discrepancies between human readers.

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

• Was it done?: No, an MRMC comparative effectiveness study, in the typical sense of evaluating human readers' improvement with or without AI assistance, was not done. This device is an automated analyzer, not an AI-assisted diagnostic tool for human interpretation of images or other complex data. The comparison was between the device and predicate devices.

• Effect size of human readers' improvement with AI vs without AI assistance: Not applicable, as this was not an AI-assisted human reading study.

6. Standalone (Algorithm Only) Performance Study:

• Was it done?: Yes, the performance described (precision, linearity, and clinical correlation) is inherently a standalone performance of the AVL OPTI Critical Care Analyzer. The device is an automated system, and its measurements were compared directly against established methods and other devices, not as a component assisting a human in real-time.

7. Type of Ground Truth Used:

• Ground Truth Type:
  • For clinical correlation: Measurements from "predicate devices" (NOVA Biomedical STAT 5, Chiron 865, AVL 995, SenDx 100, Diametrics IRMA, I-STAT 200, AVL 9181, IL 943 Flame Photometer). These predicate devices represent established and accepted methods for measuring the analytes.
  • For linearity: "Reference materials or methods" and an "AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers."
  • For precision: Evaluation against "samples plasma, reduced bovine hemoglobin solution and three levels of aqueous quality control solution."

8. Sample Size for the Training Set:

• Sample Size for Training Set: The document does not describe a "training set" in the context of a machine learning or AI model, as this device predates widespread AI development for medical devices. The device's calibration refers to internal calibration mechanisms within the disposable cassette, not a data-driven training process in the modern AI sense. "Training" for this device would refer to its engineering and development processes rather than a data subset for model training.

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

• How Ground Truth for Training Set Was Established: Not applicable as there is no mention of a "training set" in the AI/machine learning context. The calibration of the device is done via the disposable cassette, which "contains all the elements needed for calibration," suggesting pre-programmed or established calibration parameters.

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AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride.

For In Vitro Diagnostic Use

The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.

The provided document describes the AVL OPTI-check Control, a multi-analyte control solution. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of the "Implied" nature: The document does not explicitly state numerical acceptance criteria. Instead, it concludes that the device's performance "was within manufacturer's stated claims" for precision and showed "no significant difference (P < 0.05)" in correlation studies with predicate devices. This implies that the manufacturer's stated claims and the statistical significance threshold of P < 0.05 were the acceptance criteria for these aspects.

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

• Sample Size: The document mentions that for precision studies, two runs per day with 2 replicates per run were conducted for 20 days. This translates to a total of 80 measurements per analyte for each AVL OPTI Critical Care Analyzer used in the precision study (2 runs/day * 2 replicates/run * 20 days). For correlation studies, the number of patient specimens collected is not explicitly stated, but they were "remnant from patient specimens of both whole blood and serum collected for routing analysis."
• Data Provenance: The document does not specify the country of origin. The test data for correlation studies came from "remnant from patient specimens... collected for routing analysis on existing instrumentation," indicating a retrospective or opportunistic use of clinical samples. The precision studies were conducted internally on AVL OPTI Critical Care Analyzers.

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

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the device's performance. The "ground truth" for the correlation studies would be the results obtained from the "predicate devices" or "existing instrumentation" in a clinical setting.
• The personnel operating the instrumentation for the clinical correlation studies were "trained to perform and report these analyses." Their specific qualifications (e.g., radiologist, lab technician with X years of experience) are not detailed.

4. Adjudication Method for the Test Set:

• No adjudication method is described. The comparison was made against results from existing instrumentation (predicate devices).

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

• No MRMC comparative effectiveness study was done as this device is a control solution, not an interpretive diagnostic tool that involves human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This device is a control solution for analyzers, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm does not apply in this context. The described studies evaluate the control solution's performance in ensuring the accuracy and precision of the analytical instruments.

7. The Type of Ground Truth Used:

• For precision studies, the "ground truth" is typically the expected value of the control solution itself, as established by the manufacturer, against which the measured variance is compared.
• For correlation studies, the "ground truth" was the measurements obtained from "predicate devices" or "existing instrumentation" using patient specimens. This could be considered a form of "reference method" comparison, which is close to "outcomes data" in the sense that it reflects real-world clinical measurements. However, it's more specifically a comparison to established, legally marketed devices.

8. The Sample Size for the Training Set:

• The document does not explicitly describe a "training set" in the context of machine learning or AI. This product is a control solution, and its development would likely involve formulation and stability studies, rather than a data training pipeline.

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

• As there's no mention of a "training set" in an AI/machine learning context, this question is not applicable. The control levels in the solution "contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples" and "clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride." These concentrations would be established during the product's development and manufacturing process based on clinical relevance and analytical needs.

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The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb,SulfHb and metabolites; glucose and lactate in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.

The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, HHb, O2Hb, COHb, MetHb, SulfHb, Nat, K+, CI, ionized Ca*, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 16 tests per sample.

The provided text describes the AVL OMNI™ Combi Analyzer and its intended use, but it does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria in a structured table or comprehensive study report. The document describes non-clinical tests for precision and linearity for Glucose and Lactate as additions to previous submissions, and clinical tests to demonstrate correlation with legally marketed predicate devices.

However, based on the provided text, I can infer details regarding the "Precision" and "Linearity" tests for the added Glucose and Lactate analytes, which are key performance indicators for this type of device.

Here's an attempt to construct the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for precision or linearity. Instead, it describes how precision and linearity were determined and then concludes that there was "no significant difference in mean values (P<0.05) obtained on measurement by the AVL OMNI™" compared to predicate devices, and that the device is "safe and effective, and equivalent." This implies that the observed precision and linearity were within acceptable ranges relative to the predicate devices and general standards for such analyzers at the time.

For Glucose and Lactate, the study summary indicates:

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

• Precision Test:

  • Sample Size: "two runs per day with 2 replicates per run for 20 days on two AVL OMNI™ instruments" using "samples of each of the specimen types suitable for measurement on the AVL OMNI™." This totals 80 measurements per specimen type (2 runs/day * 2 replicates/run * 20 days). The number of distinct specimen types is not specified.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples and controls in a controlled non-clinical setting given the nature of precision testing.

• Linearity in NIST Standard Reference Materials:

  • Sample Size: N/A (Standard Reference Materials are used as known values). The number of measurements taken for each SRM isn't specified.
  • Data Provenance: N.I.S.T. SRM 956a Electrolyte in Human Serum and N.I.S.T. SRM 965 for Glucose.

• Linearity in Aqueous Solutions:

  • Sample Size: Not specified beyond being measured on "each of three AVL OMNI™ units."
  • Data Provenance: Gravimetrically prepared aqueous standard solutions.

• Linearity in Plasma:

  • Sample Size: Not specified beyond being measured on "two AVL OMNI™ instruments." The number of "varying ratios" of patient-sample pools is also not specified.
  • Data Provenance: "Patient-Sample Pool" with aliquots mixed in varying ratios. This is retrospective, as it uses stored patient samples.

• Clinical Testing (Correlation):

  • Sample Size: Not specified.
  • Data Provenance: "remnant from patient specimens of both whole blood and serum collected for routine analysis on existing instrumentation." This is retrospective patient data.

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

The document does not mention the use of experts to establish ground truth for the test sets. Instead, ground truth for precision is based on repeated measurements of samples, and for linearity, it is based on known concentrations in reference materials or carefully prepared solutions/pools. For clinical correlation, the ground truth would be the measurements from the legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. The document describes clinical correlation with predicate devices, which is a different type of comparison. There is no mention of human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are standalone performance evaluations of the device (AVL OMNI™ Combi Analyzer) measuring various analytes. There is no human-in-the-loop component mentioned in these performance tests.

7. Type of Ground Truth Used

• Precision and Linearity (Non-clinical):
  • Known concentrations from NIST Standard Reference Materials.
  • Gravimetrically prepared aqueous standard solutions.
  • Carefully prepared patient-sample pools with known dilution ratios.
• Clinical Correlation:
  • Measurements obtained from "legally marketed predicate devices" (e.g., Radiometer 625, NOVA Biomedical ULTRA, Chiron 865, Instrumentation Laboratories BGGE). The assumption is that these predicate devices provide the clinical "ground truth" for comparison.

8. Sample Size for the Training Set

Not applicable. This device is a diagnostic analyzer, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a system involves calibration and internal algorithms developed based on chemical and physical principles. The document mentions "Calibration" using a patented liquid calibration system.

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

Not applicable, as there isn't a "training set" in the context of AI/ML. The device's operational parameters would be established through a rigorous design and development process, including chemical and physical modeling, bench testing, and optimization using reference materials and quality controls. The calibration procedures described are essential for the device's ongoing accuracy, using known calibrant solutions.

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The AVL 9181 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.

The AVL 9181 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results. The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the AVL 9180 with the exception of this single, additional feature. The manual needle mechanism of the 9180 was replaced with the automated needle mechanism from the AVL 988-4. The electronic circuitry to control the needle mechanism are incorporated into the 9180 display board. The sampler is taken from the 988-4 without modification except that the connector is changed to a smaller type. The 9180 main board already incorporated the controller for the sampler. The 9180 software was modified to add the automatic sampling feature. Calibration and measurement sequences are taken without alteration from the 9180 (sample volume, timing and algorithms). Once the sample probe is positioned in the sample cup, aspiration, measurement, wash and recalibration sequences are identical to the 9180.

Here's a breakdown of the acceptance criteria and study information for the AVL 9181 Electrolyte Analyzer, based on the provided text:

AVL 9181 Electrolyte Analyzer: Acceptance Criteria and Study Details

The provided document describes the AVL 9181 Electrolyte Analyzer as an improved design of the existing AVL 9180 Electrolyte Analyzer [K961458], with the primary addition of an Autosampler. The studies presented focus on demonstrating that this new feature, and the overall device, performs equivalently to the predicate devices and existing manual methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific thresholds for accuracy, precision, etc. Instead, it describes performance characteristics that were evaluated and concluded to be comparable to predicate devices and manual methods. The general acceptance criterion appears to be "no significant difference" (p < 0.05) in measurement values compared to predicate devices and between manual and automated modes.

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

• Precision Test: "2 runs per day with 2 replicates per run for 20 days on two model AVL 9181 analyzers" for each configuration and specimen type. This implies 80 individual measurements per configuration/specimen type (2 runs * 2 replicates * 20 days).
• Linearity in N.I.S.T. Standard Reference Material: The specific number of measurements or distinct samples is not given, but it utilized N.I.S.T. SRM 956a Electrolyte in Human Serum.
• Linearity in Serum: "All samples were analyzed in pairs on each of two of AVL 9181 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li." Also "in pairs on each of several instrument types" for comparison. The exact number of samples is not stated.
• Linearity in Urine: "analysis of random patient urine specimens" on the specified instruments. The exact number of samples is not stated.
• Clinical Tests: "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and serum collected for routing analysis on existing instrumentation." The exact number of patient specimens is not stated.

Data Provenance:

• The N.I.S.T. SRM 956a is a certified reference material, likely of US origin.
• "Random patient urine specimens" and "remnant from patient specimens of both whole blood and serum" indicate retrospective clinical data.
• The locations of the "four field tests" are not specified, so the country of origin for the clinical data is not explicitly stated, but the submission is to the FDA, suggesting US-based or internationally recognized standards.

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

The ground truth was established by measurements from predicate devices (e.g., AVL 9180, IL Model 943 Flame Emission Photometer, Labconco Digital Chloridometer) and standard reference materials (N.I.S.T. SRM 956a). These are considered the 'gold standard' for the respective analytes. There were no human experts used to establish a "ground truth" in the interpretive sense (like reading an image). The accuracy of these measurements is inherent to the certified materials and established predicate devices.

The personnel operating the device for the clinical trials were "minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting," but they were performing analyses, not establishing a new ground truth.

4. Adjudication Method for the Test Set

No explicit adjudication method is described, as the ground truth was established by instrumental measurements and certified reference materials, not human interpretation requiring adjudication. Statistical analysis (e.g., p < 0.05) was used for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is an electrolyte analyzer, not an interpretive medical imaging or diagnostic device that would typically involve multiple human readers. The comparison was between automated device measurements and predicate device measurements.

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

Yes, a standalone performance evaluation was done. The studies assessed the AVL 9181's performance (linearity, precision, and correlation) when operating on its own, both in manual and automated modes, against established methods and predicate devices. The "algorithm" here refers to the internal analytical processes and measurement taking place within the instrument.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Certified Reference Materials: Specifically N.I.S.T. SRM 956a Electrolyte in Human Serum for linearity studies.
• Measurements from Legally Marketed Predicate Devices: These instruments serve as the established "truth" against which the new device's measurements are compared. Examples include the AVL 9180, IL Model 943 Flame Emission Photometer, Labconco Digital Chloridometer, and AVL 983 Electrolyte Analyzers.
• Established Analytical Methods: The principles of measurement and calibration sequences are identical to predicate devices, implying that these established methods constitute the "truth" for how these analytes are measured.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of medical device (an in-vitro diagnostic analyzer) typically relies on engineering design and validation against known standards and predicate devices rather than "training" in the machine learning sense. The device's "training" for its algorithms would be the manufacturing calibration and software development process, which isn't described in terms of a "training set."

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

As there is no explicit "training set" described in the context of machine learning, the question of how its ground truth was established is not applicable. The device's operational parameters are based on established chemical and electrical principles for ion-selective electrodes, calibrated against standards and proven in predicate devices.

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The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.

The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

Device: AVL COMPACT 3 pH/Blood Gas Analyzer

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating that the AVL COMPACT 3 is substantially equivalent to its predecessor (COMPACT 2) and that the changes made (numeric keypad, optimized sample volume requirements) do not introduce significant differences in performance. The acceptance criteria are implicitly derived from the existing performance of the COMPACT 2 and the statistical comparison to the "gold standard" methods (tonometry and AVL OMNI).

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

• Sample Size:
  • Numeric Keypad: Not explicitly stated, but "input values from the upper and lower limits in addition to typical input values" were tested. This suggests a qualitative rather than large quantitative test.
  • Optimization of Sample Volume Requirements (pH, PCO2, PO2): "The means of five measurements in each mode taken at 10 levels of CO2 and O2 gas mixtures spanning the reportable range" were compared. This means for each parameter (pH, PCO2, PO2) and each sample mode (syringe, capillary, mini, micro), 10 levels of gas mixtures were used, with 5 measurements per level.
    • Total measurements per parameter per mode: 10 levels * 5 measurements/level = 50 measurements.
    • Total measurements for all 3 parameters across all 4 modes: 3 parameters * 4 modes * 50 measurements/mode = 600 measurements.
    • For pH specifically, the comparison with AVL OMNI used "7 of the CO2 gas concentrations used" (tonometry levels), so presumably 7 levels * 5 measurements/level = 35 measurements per mode for this specific comparison.
• Data Provenance: The document does not specify the country of origin of the data. The data is presented as prospective in nature, as it describes validation tests conducted on the new device and its specific modifications. It does not appear to be retrospective analysis of existing clinical data.

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

• Number of Experts: Not applicable. The ground truth for the device's performance validation was established using objective scientific methods:
  • Tonometry: Gravimetrically prepared gas mixtures serve as the "gold standard" for PCO2 and PO2.
  • AVL OMNI pH/Blood Gas Analyzer: This is a pre-existing, presumably validated, reference device used for pH comparison.
• Qualifications of Experts: Not applicable. The ground truth relies on established laboratory methodologies and reference instruments, not human expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The study involved direct measurement and statistical comparison to objective standards (tonometry and a reference instrument), rather than subjective interpretation requiring adjudication among multiple human readers.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is a diagnostic instrument (pH/Blood Gas Analyzer), not an AI-assisted diagnostic imaging tool or a system involving human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, the studies described are, in effect, standalone performance evaluations of the device. The "algorithm" here refers to the instrument's internal measurement and calculation processes. The validation tests directly assess the accuracy of these measurements and calculations against recognized standards, without human intervention in the measurement or interpretation process.

7. The Type of Ground Truth Used:

• Tonometry: For PCO2 and PO2, the ground truth was established using gravimetrically prepared gas mixtures (a highly accurate, fundamental measurement method).
• Reference Instrument: For pH, the ground truth included comparison to measurements obtained from an AVL OMNI pH/Blood Gas Analyzer, which serves as a validated reference device. This falls under the category of a "reference standard" or "comparative method."

8. The Sample Size for the Training Set:

Not applicable. This device is a traditional analytical instrument, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The instrument's algorithms are based on established electrochemical principles and fixed mathematical equations.

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 and physical chemistry principles, rather than learning from data. The document mentions "Calibration is performed automatically by the instrument on power-on" and describes various calibration modes, but this refers to internal self-calibration using known reference solutions, not a machine learning training process.

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