(280 days)
The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice, specialty physician, and hospital settings.
SPM-300 is a pulmonary function monitoring system consisting of a spirometry data acquisition unit (spirometer handle and mouthpiece) and a host device that provides data analysis and management, display and user interface functions.
This document describes the Bionet SPM-300 Spirometer and its performance testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SPM-300 are based on compliance with ATS (American Thoracic Society) standards for spirometry measurements. The reported device performance is that it meets these standards.
| Acceptance Criteria (ATS Standards) | Reported Device Performance (SPM-300) |
|---|---|
| Accuracy for FVC | Complies with ATS standards |
| Accuracy for FEV1 | Complies with ATS standards |
| Accuracy for MVV | Complies with ATS standards |
| Accuracy for PEF | Complies with ATS standards |
| Repeatability for FVC | Complies with ATS standards |
| Repeatability for FEV1 | Complies with ATS standards |
| Repeatability for MVV | Complies with ATS standards |
| Repeatability for PEF | Complies with ATS standards |
| Electrical Safety (IEC 60601-1) | Satisfies requirements |
| EMI (Electromagnetic Interference) (IEC 60601-1-2) | Satisfies requirements |
| Biocompatibility (ISO 10993 for mouthpiece) | Meets or exceeds requirements for patient contact duration ≤ 24 hours |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials with patient data. Instead, it refers to non-clinical testing to demonstrate compliance with ATS standards. This implies the use of calibrated equipment and simulated airflow patterns to assess accuracy and repeatability. The data provenance is non-clinical, likely generated in a laboratory setting by an independent testing organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the testing appears to be non-clinical and focused on adherence to technical standards rather than clinical diagnosis, the concept of "experts establishing ground truth" in the traditional sense of medical image interpretation or clinical diagnosis doesn't directly apply. The "ground truth" for the test set would be the known, precise values generated by calibrated spirometry simulation equipment, against which the SPM-300's measurements are compared to ensure they fall within ATS-defined tolerances. The ATS standards themselves are established by expert consensus in respiratory medicine.
4. Adjudication Method for the Test Set
Not applicable since the testing is described as non-clinical and based on objective measurements against established technical standards (ATS).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a non-clinical performance study and a comparison to a predicate device for substantial equivalence, not an MRMC comparative effectiveness study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's technical specifications and measurement accuracy were assessed independently. The performance information provided pertains to the device's ability to accurately measure pulmonary function parameters according to ATS standards. This is a standalone assessment of the device's core functionality.
7. The Type of Ground Truth Used
The ground truth used for the performance testing (specifically for accuracy and repeatability of FVC, FEV1, MVV, and PEF) would be known, precisely generated airflow and volume patterns from calibrated spirometry test equipment. For biocompatibility, the ground truth refers to established ISO 10993 standards for material safety.
8. The Sample Size for the Training Set
Not applicable. This device is a spirometer for measuring lung function, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).