(27 days)
- Device Functionality: Spirometry .
- Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
- Patient Population: Male/Female, Pediatric to Adult .
- Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)
The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.
The Orbit spirometer includes the following components:
- . Spirometer
- Spirometer Pressure Tube .
- Disposable pneumotachometer (mouthpiece)
- Office Medic Software .
- Host PC (User Provided) .
Here's an analysis of the provided text regarding the QRS Diagnostic Orbit Spirometer, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The submission indicates that the QRS Diagnostic Orbit Spirometer's performance is demonstrated by its compliance with established standards. The table below summarizes these standards and the reported compliance.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| American Thoracic Society (ATS/ERS) 2005 Standard | Complies |
| Safety IEC/EN 60601-1 3rd Ed. (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Complies |
| Electromagnetic Compatibility (EMC) IEC/EN 60601-1-2 3rd Ed. (Medical Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards." However, it does not provide details on the sample size used for performance testing (if human subjects were involved), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The testing primarily focused on compliance with technical standards for spirometers rather than direct clinical performance data from a patient cohort.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the "study" primarily revolved around testing compliance with technical standards (ATS/ERS, IEC/EN), rather than a clinical trial with patient data and diagnosed outcomes, there's no mention of experts establishing ground truth for a test set in the traditional sense of clinical diagnosis. Compliance with standards would typically be assessed by engineers or technicians with expertise in medical device testing and regulatory standards.
4. Adjudication Method for the Test Set
As there's no mention of a clinical test set requiring diagnostic interpretation, there's no information provided on an adjudication method (like 2+1 or 3+1). The "adjudication" in this context would be the determination of whether the device's measurements meet the specifications outlined in the technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (SpiroCard) based on technical specifications and compliance with standards, not on comparing reader performance with and without AI assistance. The device itself is a spirometer, which measures physiological parameters, and not an AI-driven diagnostic imaging interpretation tool that would typically involve a MRMC study.
6. Standalone Performance Study
The "Summary of Performance Testing" refers to testing of the device itself to verify compliance with the listed standards. This implies a standalone performance evaluation (algorithm only performance, in the sense of the device's measurement and calculation capabilities) was conducted against the criteria set by these standards. The device's primary function is to acquire and analyze pulmonary function data, and its performance is judged on the accuracy and reliability of these measurements as per the standards.
7. Type of Ground Truth Used
The ground truth used for this device involves the specifications and requirements outlined in the American Thoracic Society (ATS/ERS) 2005 Standard for spirometry. This standard sets forth the acceptable ranges and accuracy for various spirometric parameters (e.g., volume, flow, timing). The device's measurements were compared against these established technical and physiological benchmarks, which serve as the "ground truth" for its accuracy and functionality.
8. Sample Size for the Training Set
This document describes a medical device (spirometer) that measures physiological parameters. It does not suggest the use of machine learning or AI models that require a "training set" of data in the typical sense. Therefore, there is no information provided about a training set size. The device's functionality is based on established physics and engineering principles, and its "training" would be its design, calibration, and manufacturing processes to meet the defined standards.
9. How the Ground Truth for the Training Set Was Established
Given that there is no indication of a training set for machine learning, this question is not applicable to the information provided. The "ground truth" for the device's operation is inherently built into the design and calibration to comply with the ATS/ERS standards, which are developed by expert consensus in respiratory medicine.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).