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, 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.

Ask a specific question about this device