Search Results

The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.

Device Description

The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Precision Medical, Inc. Oxygen Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Maxtec)	Reported Device Performance (Precision Medical)	Test Method/Report
Measurement Range	0.0 - 100%	0.0 - 100%	Not specified
Resolution	0.10%	0.10%	Not specified
Accuracy & Linearity	±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale.	±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale.	Precision Medical Test # 699-1
Total Accuracy	±3% Actual Oxygen Level over full operating temperature range	±3% Actual Oxygen Level over full operating temperature range	Not explicitly listed as a separate test, but implied by specs
Response Time	90% of final value in approximately 15 seconds at 23°C	90% of final value in approximately 12 seconds at 25°C	Not specified
Operating Temperature	15°C - 40°C [59°F - 104°F]	10°C - 45°C [50°F - 113°F]	Precision Medical Test # 699-4
Storage Temperature	-15°C - 50°C [5°F - 122°F]	-15°C - 50°C [5°F - 122°F]	Not specified
Humidity	0 - 95% [non-condensing]	0 - 95% [non-condensing]	Precision Medical Test # 699-4
Power Requirements	2, AA Alkaline Batteries [2 x 1.5 Volts]	4, AA Alkaline Batteries [4 x 1.5 Volts]	Not specified
Battery Life	Approximately 3000 hours in typical use	Approximately 1500 hours in continuous use. Non alarm condition	Not specified
Low Battery Indication	"LOW BAT" icon displayed on screen	"LOW BAT" icon displayed on screen	Not specified
Sensor Type	Maxtec MAX-250E galvanic fuel cell	Precision Medical 504877 Galvanic fuel cell	Not specified
Expected Sensor Life	>900,000% O2 Hours	>1,000,000% O2 Hours	Not specified
Alarm System	high/low alarms, flashing red LEDs, audible alarm beeper	high/low alarms, flashing red LEDs, audible alarm beeper	Not specified
Low Alarm Range	18% - 99%	18% - 99%	Not specified
High Alarm Range	19% - 99%	19% - 99%	Not specified
Alarm Accuracy	Exact to displayed alarm value	Exact to displayed alarm value	Not specified
Dimensions	3.5"[W] x 5.5"[H] x 1.5"[D] [89mm x 140mm x 38mm]	3.6"[W] x 5.4"[H] x 1.5"[D] [89mm x 140mm x 38mm]	Not specified
Weight	Approximately 0.92 lbs. [417g]	Approximately 1.11 lbs. [430g]	Not specified
Cable Length	10 ft. [3m]	10 ft. [3m]	Not specified
Diverter Fitting	fits industry standard, 15 mm "T" adapter	fits industry standard, 15 mm "T" adapter	Not specified
Electromagnetic Compatibility	Not explicitly stated as acceptance criteria, but tested for predicate	Complied with IEC 60601-1-2:2004	Retlif Testing Laboratories Test Report No. R-2915P
Software Validation	Compliance with Guidance document: General Principles of Software Validation	Complied with Guidance document: General Principles of Software Validation, Final Guidance for Industry and FDA Staff	Not specified
Mechanical / Climatic	Not explicitly stated as acceptance criteria, but tested for predicate	Passed	Precision Medical Test # 699-4

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only lists the tests performed.

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

This information is not provided in the document. The tests performed are engineering and performance validation tests on the physical device itself (e.g., accuracy, temperature range), not on interpretations by experts.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are technical performance measurements of the device, not analyses requiring expert adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The device is an oxygen monitor, which provides a direct measurement, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical oxygen monitor, not an algorithm. Its performance is inherent to its physical and electronic design. The data provided describes standalone device performance.

7. Type of Ground Truth Used

The ground truth used for these performance tests would be calibrated reference standards or known environmental conditions. For example, for "Accuracy & Linearity," the ground truth would be precisely measured oxygen concentrations and controlled temperature/humidity. For "Electromagnetic Emissions & Immunity," the ground truth would be established by the testing standards themselves.

8. Sample Size for the Training Set

This is not applicable as the Precision Medical, Inc. Oxygen Monitor is a hardware device that measures oxygen concentration using a galvanic fuel cell. It does not employ machine learning or AI models that require a training set.

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

This is not applicable as there is no training set for this device.

Ask a Question

Ask a specific question about this device

Page 1 of 1