(434 days)
The IQTeQ Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management.
The IQTeQ Spirometer is for use in hospitals, clinics and physician/clinician offices by individuals that have received minimal instruction or training in the administration of spirometry tests. The IQTeQ Spirometer operates with an IBM or compatible computer using a USB port (Universal serial bus) connection and the PC's installed IQTeQ Spirometer Windows™ compatible software. Minimum PC and operating system requirements are specified in the IQTeQ Spirometer Manual.
The IOTeO Spirometer is indicated for use with male/female adult patients and male/female pediatric patients to evaluate, access, describe, measure, or monitor.
- Symptoms, signs, or abnormal laboratory tests 】.
- Effects of disease on pulmonary function 2.
- Individuals at risk for pulmonary disease 3.
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- Preoperative risk
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- Post-surgical prognosis
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- Pre-treatment health status
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- Therapeutic interventions
- The course of disease affecting lung function 8.
- Persons exposed to pollutants 9.
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- Adverse reactions to drugs with known pulmonary toxicity
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- Rehabilitation programs
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- Risks as part of an insurance evaluation
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- Individuals for legal reasons
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- Epidemiological surveys
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- Derivation of reference equations
The IQTeQ Spirometer2001 is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB) port cable connection. Windows based software on the PC runs the diagnostic spirometer application.
The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital conversion, USB microcontroller and connection to the USB cable. The electronic component is screened and connects to the USB cable screen. The entire electronic component is sealed in epoxy (Eli-Cast FR 453) and permanently fixed into the handle with epoxy. The electronics in the handle is powered by the 0 and 5volt power supply, which is provided with all USB ports. The top of the handle has a circular tube for connection to the flow tube, which is inserted into the handle tube.
The flow tube, which includes a laminar flow air resistance element, is inserted into the handle tube. Porting of the flow tube and the handle tube allows air pressure to connect to the pressure transducer in the handle. Two 'O' rings maintain an airtight seal between the tubes. The flow tube includes an inert ceramic (CORDIERITE) laminar flow air resistance element.
The patient is connected by mouth to a bacterial filter, which is fitted to the flow tube. The patient breathes as instructed through the flow tube. The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter. The digitized 12 bit data is sent to the PC via the USB port at 335, 12bit samples per second. The IQTeQ application software which requires Windows 98 SE or later calculates the flow and integrates flow to calculate volume. The flows are calculated from the 12 bit data by applying the calibration polynomial algorithm. Therefor all flow and volume data is calculated in real time for the flow-volume measurements which includes: Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as MVV and SVC.
Here's an analysis of the provided text to extract information about the IQTeQ Spirometer 2001's acceptance criteria and study details:
IQTeQ Spirometer 2001: Acceptance Criteria and Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states that "As with the predicate devices, the IQTeQ Spirometer has been tested for compliance to the ATS1994 standards." This indicates that the American Thoracic Society (ATS) 1994 standards are the acceptance criteria for the device's performance.
| Acceptance Criteria (ATS 1994 Standards) | Reported Device Performance |
|---|---|
| Compliance with ATS 1994 standards for spirometry parameters (e.g., Peak Flow, FVC, Forced Expiratory Flows, Forced Inspiratory Vital Capacity, MVV, SVC) | The device "has been tested for compliance to the ATS1994 standards." (This implies it met the standards, though specific performance metrics against ATS thresholds are not provided in the summary). |
| General electrical safety and emission standards (EN60601-1, IEC60601-1) | "The IQTeQ Spirometer also complies with the EN60601-1, IEC60601-1 electrical safety and emmision standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing against the ATS 1994 standards. It only mentions a "calibration procedure that requires 6 varying strokes from a 3 liter syringe." This calibration procedure is distinct from the overall performance testing against ATS standards.
The data provenance is not explicitly mentioned but can be inferred as likely from retrospective testing conducted by the manufacturer to demonstrate compliance with the ATS 1994 standards. The manufacturer is based in Cape Town, South Africa.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts used to establish a ground truth for the test set. The compliance to ATS 1994 standards implies comparison against a recognized standard, but the specific method of collecting or validating the test data is not elaborated.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's standalone performance and its equivalence to predicate devices, not on how human readers' performance might improve with the device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The document explicitly states: "The IQTeQ Spirometer has been tested for compliance to the ATS1994 standards." This refers to the device's ability to accurately measure spirometry parameters on its own, based on its internal algorithms and hardware. The "IQTeQ application software... calculates the flow and integrates flow to calculate volume... all flow and volume data is calculated in real time."
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation appears to be ATS 1994 standards, which represent expert-consensus-based guidelines for spirometry measurements. The device's measurements are implicitly compared against these accepted industry standards.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. The device calculates parameters based on "calibration polynomial algorithm" and "12 bit data," implying a fixed algorithm informed by initial engineering and calibration rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for an AI/machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device relies on a "calibration procedure that requires 6 varying strokes from a 3 liter syringe," which is a form of calibration rather than a training set for an AI model.
§ 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).