Search Results

The AVL OPTI 1 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood in either a traditional blood gas or clinical Iaboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The AVL OPTI 1 is a microprocessor-based instrument using optical fluorescence for the measurement of pH, PCO2 and PO2 in samples of whole blood. A disposable, single-use cassette containing three optical fluorescence sensors is packaged in a sealed, foil pouch which bears a bar coded label with calibration and identification information. Immediately prior to use, the bar coded calibration information is read into the instrument and the cassette positioned in the instrument for calibration verification prior to measurement using a liquid buffer contained within the cassette, und a precision calibration gas contained in a cylinder inside the OPTI 1.

In order to provide our customers with an additional level of security in the quality control of results obtained with the OPTI 1, AVL has modified the operation of the OPTI 1 to allow the measurement of a traditional, ampouled, aqueous quality control product prior to any measurement of a patient's blood specimen in the same cassette.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined "acceptance criteria" in the traditional sense (e.g., "The device must achieve a correlation coefficient of X for pH"). Instead, the document presents comparative performance data against predicate devices or known standards as evidence of substantial equivalence and safety/effectiveness. The implicit acceptance criteria are that the device's performance should be comparable to, and not significantly different from, legally marketed predicate devices.

The reported device performance is presented as regression statistics (slope, Y-intercept, correlation coefficient, Sy*x) comparing the AVL OPTI 1 to either a reference method (tonometered blood, AVL 995 with NIST traceable buffers) or other predicate devices in clinical settings.

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

• Nonclinical Study:

  • Sample Size: Not explicitly stated as a single number for each parameter. The study involved:
    • "Each measurement of OPTI-trol was followed by a blood measurement in the same cassette, then a second measurement taken in the same instrument with a second cassette. This protocol was repeated to obtain 3 sets of measurement for each mode of operation for each of 5 levels of gas containing CO2 and then repeated for each of the three levels of OPTI-trol." This suggests a substantial number of measurements were taken across the levels and modes for the carry-over study.
    • "Whole blood samples were analyzed on four (4) OPTI 1 systems and on 1 AVL 995 after being tonometered at 37 ℃ to various concentrations of CO2 and O2 concentrations certified to 0.03% absolute by the manufacturer." The table later shows the ranges for pH (7.0 - 7.6), PCO2 (11-104), and PO2 (21-515), implying multiple samples across these ranges were tested.
  • Data Provenance: Not specified regarding country of origin. The study was conducted internally by AVL Scientific Corporation. It appears to be retrospective in the sense that existing methods/samples (tonometered blood, OPTI-trol) were used in a controlled laboratory setting.

• Clinical Study:

  • Sample Size:
    • pH: 92 measurements in OPTI-trol Mode, 92 in Patient Mode, and a Total of 101 measurements for the combined data when compared to the IL 1312 predicate device.
    • PCO2: Same as pH (92/92/101).
    • PO2: Same as pH (92/92/101).
  • Data Provenance: "Three field tests were conducted... Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation." This indicates the data is retrospective, using remaining portions of previously collected patient samples. The specific country of origin is not stated but implied to be where the three clinical sites were located.

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

This information is not provided. The "ground truth" for the nonclinical study was established by laboratory methods (tonometered blood with certified gas concentrations and NIST traceable pH buffers) and for the clinical study by comparative measurements on predicate devices which are themselves assumed to have a well-established accuracy in routine clinical use. There is no mention of human experts establishing ground truth for individual measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct physical/chemical measurements or comparison to predicate devices, not by human expert review that would require an adjudication method.

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

Not applicable. This device is a blood gas analyzer, not an AI-assisted diagnostic imaging device that involves human readers. The study focuses on the device's analytical performance.

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

Yes, a standalone performance of the device without human interpretation (beyond operating the instrument) was the primary focus of the studies. The device itself performs the measurements and outputs results. The clinical study compares its output directly to other devices' outputs. The "human-in-the-loop" here refers to trained personnel performing the tests and reporting results, but not interpreting raw data from the device to establish a diagnosis or ground truth.

7. The Type of Ground Truth Used

• Nonclinical Study:
  • For pH: NIST traceable pH buffer solutions (QUALIDATA, RNA Medical)
  • For PCO2 and PO2: Tonometered whole blood specimens with gas concentrations certified to 0.03% absolute by the manufacturer.
• Clinical Study:
  • Comparative analysis against legally marketed predicate devices (IL Model 1312 pH/Blood Gas Analyzer, AVL 995 pH / Blood Gas Analyzer, and AVL OMNI pH / Blood Gas / Electrolyte and tHb Analyzer). The assumption is that these predicate devices provide an accepted clinical reference or "ground truth" for the context of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (blood gas analyzer) for FDA 510(k) clearance, not a machine learning or AI model that requires a "training set" in the computational sense. The device is based on fluorescence optode technology, not an adaptive learning algorithm.

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

Not applicable, as there is no training set for an AI model. For the device's internal calibration, the document states: "The pH channel is calibrated with precision pH buffer solution contained in the cassette" and "performs a calibration verification on the sensors for pH, pCO2 and pO2 by passing a precision calibration gas mixture across the optode sensors." This internal calibration process relies on known standards embedded within the cassette or instrument.

Ask a specific question about this device