(134 days)
The CardioTech Spirometry System, Model GT-105, is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health environments.
The CardioTech GT-105 Spirometry System measures a wide range of physiological parameters such as SVC, FVC, MVV, and MV and consists of a spirometer and a flow sensor.
The flow sensor head, which includes a flow air resistance element, is mounted on the flow sensor body. Via a disposable mouthpiece and filter, the patient breathes as instructed through the flow sensor head. The pressure transducer in the spirometer then measures the differential pressure in the flow sensor head which is digitized into 12 bit data by an A/D converter.
The data can be transferred via RS-232C/USB interfaces to a PC in which Spirobank software is installed. Since the software includes a number of screens and 'buttons' that help to logically perform the function, the medical practitioner (e.g., technician) can print (reports), save and recall the data/results.
The provided document is a 510(k) summary for the CardioTech GT-105 Spirometer. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and the comprehensive study proving its performance.
The document mentions performance testing in accordance with the American Thoracic Society (ATS) standard, but it does not provide the acceptance criteria values or the specific results from that testing. It also does not describe an AI-driven device, so questions related to AI performance, such as MRMC studies, human reader improvement with AI, or standalone algorithm performance, are not applicable.
Here's a breakdown of what can be answered and what cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| (The document states testing was done "in accordance with the industry standard developed by the American Thoracic Society," but does not list specific numerical acceptance limits or the device's measured performance against them.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The device is a diagnostic spirometer, which directly measures physiological parameters. Ground truth for its performance would typically be established by comparing its measurements to a gold standard measurement system or a reference standard, rather than expert consensus on images or interpretations. The document does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See explanation above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The device described is a spirometer, a hardware device for measuring lung function. It is not an AI-driven diagnostic imaging device or an AI assistant for human readers. There is no indication of AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See explanation above. The device is a spirometer with software for data display and management, not a standalone algorithm performing diagnostic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that performance testing was conducted against the "industry standard developed by the American Thoracic Society." For a spirometer, this would typically involve comparing measurements (e.g., FVC, FEV1) to reference values established by the ATS standard or to a highly accurate calibration device, rather than expert consensus or pathology in the context of imaging. However, the exact nature of this "ground truth" or reference standard for testing is not detailed in the provided text.
8. The sample size for the training set
- Not Applicable. The device described is a spirometer, a hardware device with embedded software for data acquisition and display. It is not an AI/ML device that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
§ 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).