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The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.

The AII 2000 Series Oxygen Analyzers and Monitor can be positioned on a table top or pole (tripod wire stand and V-mount dovetail attachments are mounted on the back of the unit) and are readily portable from one location to another. They provide continuous, fast, reliable and accurate oxygen measurements of up to 100% oxygen levels delivered by medical oxygen delivery equipment and respiratory care systems. The heart of each unit is the oxygen sensor, a self-contained galvanic fuel cell sensor. The sensor is specific to oxygen and The relationship between the sensor's signal and changes with the oxygen concentration is both proportional and linear. A battery powered state-of-the-art micro-processor converts the sensor's signal output representing the partial pressure of oxygen in the gas stream being analyzed. The resulting oxygen reading is displayed by a large easy to read backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The microprocessor is controlled from a keypad and provides features like system diagnostics, warning indicators, controls and an alarm capability for continuous monitoring that enhance both safety and effectiveness.

This document describes the Analytical Industries Inc. AII 2000 Series Oxygen Analyzer/Monitor, a device designed to measure oxygen concentration in breathing gas mixtures. The provided information primarily focuses on the device's technological characteristics, intended use, and regulatory clearance. It does not contain acceptance criteria for performance metrics based on a specific study, nor does it provide details of a clinical study to prove such criteria were met.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or numerical performance targets are stated in the provided documentation. The document focuses on regulatory equivalence to predicate devices and general functional descriptions.

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

The document does not describe a specific clinical "test set" or data provenance in the context of device performance validation. It refers to "bench testing" and "third-party testing" for software design and analyzer performance.

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

Not applicable. No clinical test set with human expert-adjudicated ground truth is described.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document does not discuss human reader performance, AI assistance, or an effect size.

6. Standalone Performance Study (Algorithm Only)

The document refers to software validation and "bench testing" and "third-party testing" for analyzer performance. While this implies a standalone assessment of the device, specific details about a formal standalone study with quantifiable results against predefined acceptance criteria are not provided. The focus is on the software, sensor, and overall analyzer function in relation to regulatory guidelines.

7. Type of Ground Truth Used

For the "bench testing" and "third-party testing" mentioned, the ground truth would most likely be established by controlled laboratory conditions using calibrated gas mixtures with known oxygen concentrations. This is an objective, quantitative ground truth.

8. Sample Size for the Training Set

Not applicable. The device is an oxygen analyzer, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its function is based on a galvanic fuel cell sensor and a microprocessor converting a signal.

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

Not applicable. As stated above, there is no training set for an AI/ML algorithm. The device's operation relies on established physical principles and calibration against known standards. Calibration of the oxygen sensor and the analyzer to known oxygen concentrations would establish the "ground truth" for ensuring the device's accuracy.

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