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The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to evaluate the output of an oxygen concentrator. Its intended use is to provide information to the service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient.

The Invacare Check O2 Plus is a lightweight, battery powered device which measures oxygen gas concentration, flow and pressure from an oxygen concentrator. The device is a standalone product and does not have any accessories, power supply adapters or fittings. This device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm delivery of oxygen to a patient.

The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species mixture inherent with the output flow of a concentrator. Information provided is the concentrator's oxygen concentration, flow and pressure. Continuous monitoring of output gas flow between an operating concentrator and a patient is not possible. Use with any downstream devices or patient accessories is also not possible.

It is further intended that this device be used on clean, dry and unhumidified concentrator output In conjunction with the operating temperature of oxygen concentrators, the ambient gas. temperature range of the Check O2 Plus is within the range of +10 to +35 degrees Celsius and should remain in a dry indoor environment.

The concentrator gas is expected to fall within the following ranges and will be measured with the accuracy's listed below.

The provided document describes the Invacare Check O2 Plus Oxygen Analyzer, a device designed to evaluate the output of an oxygen concentrator. The document details the device's intended use, technological characteristics, and a claim of substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "In all instances the Check O2 Plus met the required performance criteria and functioned as intended." This implies that the device successfully met all the specified acceptance criteria.

Regarding the study that proves the device meets the acceptance criteria:

The document briefly mentions performance data but does not provide a detailed study design or results. It states:

"The Invacare Check O2 Plus was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's November 1993 document entitled "Reviewer Guidance for Premarket Notification Submissions". In all instances the Check O2 Plus met the required performance criteria and functioned as intended."

Based on the provided text, the following information about the study is either not present or cannot be definitively determined:

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not specified.
* Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It likely refers to internal testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
* Not specified. The testing likely involved comparison to calibrated reference instruments rather than expert human evaluation for ground truth.

4. Adjudication Method for the Test Set:
* Not applicable/Not specified. Given the nature of the device (measuring physical parameters), ground truth would typically be established using highly accurate reference instruments, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or interpretation tasks where human readers are involved. The Invacare Check O2 Plus is a measurement device for service personnel, not a diagnostic tool for patient care.

6. Standalone (Algorithm Only) Performance Study:
* Yes, the performance data described would inherently be a standalone study as it refers to the device's measurements directly. There is no human-in-the-loop performance described for its intended use by service personnel evaluating concentrator output.

7. Type of Ground Truth Used:
* Instrumental Reference/Calibrated Standards: Although not explicitly stated as "ground truth," the testing "in accordance with the electrical, mechanical and environmental performance requirements" implies that the device's measurements were compared against highly accurate and calibrated reference instruments for oxygen concentration, flow, and pressure.

8. Sample Size for the Training Set:
* Generally not applicable for this type of device. The Invacare Check O2 Plus is a measurement instrument, not an AI or machine learning algorithm that requires a training set in the conventional sense. Its "calibration" would involve internal adjustments and testing against known standards, not a data-driven training process.

9. How the Ground Truth for the Training Set Was Established:
* Not applicable (see point 8). The device is likely calibrated during manufacturing using established physical standards.

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