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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 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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