(138 days)
The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required. The device consists of four basic elements: Base Device, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.
Here's a breakdown of the acceptance criteria and study information for the Precision Medical Inc. PM5950 Accu O2 Oxygen Analyzer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Technical Specifications & Comparison) | Reported Device Performance (PM5950 Accu O2 Analyzer) |
|---|---|
| Measurement Range 0.0 - 100% Oxygen | 0.0 - 100% Oxygen |
| Resolution 0.1 Increments | 0.1 Increments |
| Total Accuracy ± 3.0% Actual Oxygen Level over full operating temperature range | ± 3.0% Actual Oxygen Level over full operating temperature range |
| Drift of Measurement 1,000,000 O2 % Hours (equivalent to 2 years in typical applications for a similar sensor) | 2-years in typical applications for the Maxtec MAX 13/CAG-13 Galvanic fuel sensor (the same sensor used in the predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for tests related to accuracy, drift, response time, etc. It lists a series of compliance reports and tests performed by Precision Medical Inc. to demonstrate substantial equivalence. These are:
- Ingress of water ISO 80601-2-55 (201.11.6.5)
- Oxygen Analyzer Measurement Accuracy ISO 80601-2-55:2011 (201.12.1.101,102,104)
- Shock & Vibration Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (201.15.3.5.101)
- EMC Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (202.6.2)
- Oxygen Analyzer - Leakage to Atmosphere ISO 80601-2-55:2011 (201.102)
- Operating and Storage Temp
- Operating and Storage Temperature of the PM5950 O2 Analyzer Review
- Software Validation of PM5950
- Effects of Elevation-Barometric Pressure Change
- Drop Test of PM5950 in Shipping Box
- Performance Test
- Process Validation of the PM5950
- Life Expectancy of the Keypad
- Label Durability
- Cleaning and disinfection of ME Equipment of ME Systems
- Compatibility with substances used with ME Equipment
The data provenance is from in-house testing conducted by Precision Medical, Inc. in the USA. The data is prospective in nature, as it was generated specifically for the 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing appears to be primarily engineering and performance verification against specified technical standards and internal criteria, rather than expert-based ground truth establishment for a diagnostic output.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (an oxygen analyzer), testing would likely involve direct measurement against known gas concentrations or calibrated reference instruments, rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI devices where human readers are involved in making diagnoses or assessments. The PM5950 Accu O2 Analyzer is a measurement device for oxygen concentration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance evaluation was done. The entire suite of tests (accuracy, response time, drift, environmental robustness, software validation, etc.) outlined in section "8. Declarations of Conformity and Summary Reports" represents the standalone performance evaluation of the device itself. The device is designed to provide direct measurements without human interpretation or algorithm modification once calibrated.
7. The Type of Ground Truth Used
The ground truth for the device's performance (e.g., accuracy, response time) would be established using calibrated reference standards and instruments to generate known oxygen concentrations. For other tests (like shock, vibration, ingress of water, EMC), the ground truth is defined by the specific requirements and methodologies of the referenced international and national consensus standards (e.g., ISO 80601-2-55, IEC 60601 series).
8. The Sample Size for the Training Set
This information is not applicable/not provided. The PM5950 Accu O2 Analyzer is a hardware-based measurement device that relies on a galvanic fuel cell sensor and a microprocessor. It does not appear to utilize machine learning or AI models that require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above (no AI/ML training set).
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).