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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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