(187 days)
The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries
Please note that the provided text is a 510(k) summary, which is a regulatory document. While it mentions performance testing and compliance with standards, it does not contain a detailed study report with all the requested information for a scientific paper.
Therefore, I can extract the available information but significant parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, ground truth establishment methods, expert details, and MRMC studies, are not present in this regulatory summary.
Here's an attempt to answer your questions based only on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ATS standards) | Reported Device Performance (as implied by conclusion) |
|---|---|
| Requirements for accuracy defined by the American Thoracic Society (ATS) | Demonstrated compliance with ATS accuracy requirements. |
| Compliance with hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification | Demonstrated compliance with hardware and software requirements. |
| Conformance to applicable requirements in Section (h)(1)-(7) and Section (i) of Appendix A of 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" | Demonstrated conformance to these specified sections. |
| Conformance with IEC601-1 requirements for electrical safety | Demonstrated conformance to IEC601-1. |
| Biocompatibility testing in accordance with G95-1 / ISO-10993 | Demonstrated compliance with G95-1 / ISO-10993. |
Note on "Reported Device Performance": The document states that testing was conducted and demonstrates compliance or conformance. It does not provide specific numerical performance metrics (e.g., specific accuracy percentages, standard deviations, or ranges of error) as a scientific study report would.
Additional Information Not Contained in the Document:
Due to the nature of a 510(k) summary (which focuses on regulatory compliance and substantial equivalence rather than detailed research study reporting), the following information is not available in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
- 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, as no expert-based ground truth is explicitly mentioned for performance evaluation in this context. The "ground truth" for a spirometer is typically established by physical standards and calibrated devices.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the type of device and testing described.
- 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. This is a spirometer, not an AI-assisted diagnostic imaging device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The spirometer itself is a standalone device in terms of measuring lung function. The testing described would inherently be evaluating the algorithm/device's standalone performance against known physical standards.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a spirometer, the "ground truth" for accuracy testing would typically involve comparisons to established physical standards (e.g., highly accurate flow/volume simulators or other calibrated spirometers). The document mentions "requirements for accuracy defined by the American Thoracic Society," implying that the ground truth is based on these established physiological and measurement standards.
- The sample size for the training set: Not applicable. Spirometers are not typically "trained" using patient data in a machine learning sense. Their function is based on physical principles of flow measurement.
- How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
Summary of what's available vs. what's missing:
The document clearly states:
- The device is a spirometer.
- It uses ultrasonic technology for flow measurement.
- It claims substantial equivalence to predicate devices (Puritan-Bennett Renaissance Spirometer and others).
- Performance testing was conducted to demonstrate compliance with ATS accuracy requirements, hardware/software specifications, specific FDA guidance sections, IEC601-1 for electrical safety, and ISO-10993 for biocompatibility.
- The overall conclusion is that it is substantially equivalent and safe/effective.
However, it lacks the granular detail of a research study that would provide specific sample sizes, demographic information of a test set, detailed numerical performance results (e.g., mean absolute error, precision measurements), and specific methodologies for establishing ground truth beyond reference to general standards.
§ 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).