Search Results

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.

Ask a specific question about this device