(125 days)
Intended to perform spirometry in hospital and clinical environments, for adult patients and pediative patients aged 6 years and above.
The SPIROLYSER® Q13 is an electronic spirometer operating on a PC, for the exploration of respiratory function. The spirometer is composed of a single-use sensor that propels the air (FLEISCH principle) and obtains a difference in pressure. Definition of Fleisch type pneumotachograph: A pneumotachograph that measures flow in terms of the proportional pressure drop across a resistance consisting of numerous capillary tubes in parallel. The SPIROWIN® EXPERT software acquires samples sent by the spirometer and determines a flow and a volume so as to display the curves and deduce results. The SPIROLYSER® 013 spirometer is a portable device. In normal use, the patient holds it by the handle, placing the single-use sensor in the mouth. The SPIROLYSER® Q13 is directly powered by the computer USB port via its USB lead. The SPIROWIN® EXPERT software (on the attached PC) calculates, displays and stores data to help the practitioner in the exploration of a patient's respiratory function.
Here's a breakdown of the acceptance criteria and study information for the Q13 SPIROLYSER® based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance Study for Q13 SPIROLYSER®
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Q13 SPIROLYSER® are largely aligned with the performance characteristics of its predicate device, the SPIROLYSER SPL-50 (K010761), and additionally demonstrate compliance with the ATS 2005 Spirometry Testing Recommendations.
| Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Q13 SPIROLYSER®) | Notes |
|---|---|---|---|
| Measurement Range | -9 l/s to +14 l/s | -14 L/s to +14 L/s | New device is better, exceeding predicate's range. |
| Volumes | 0 to 10 liters | 0 to 10 liters | Same as predicate. |
| Accuracy | +/- 3% | "Bench testing also included Compliance with ATS 2005 Spirometry Testing Recommendations. Using its flow/volume Pulmonary Waveform Generator the FIM MEDICAL has carried out all essential requirements recommended by the American Thoracic Society (ATS 2005). The measurements were performed several times in order to check repeatability, as well as the performance of the Spirolyser® Q13 spirometer. All the results obtained are below the tolerated maximum errors on all the FT and PW curves tested, in both positive and negative flows. All test results were satisfactory." |
7. Type of Ground Truth Used
- Ground Truth Type:
- Technical Specifications: The primary ground truth for accuracy, range, and resolution was based on the design specifications derived to meet or exceed those of the predicate device.
- ATS 2005 Spirometry Testing Recommendations: This serves as a widely accepted industry standard for spirometry device performance, and the device was tested against its requirements for flow/volume and pulmonary waveform generation.
- Flow/volume Pulmonary Waveform Generator: This physical instrument provided the controlled and known inputs against which the device's measurements were compared.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not mention a "training set" in the context of machine learning or AI. The Q13 SPIROLYSER® is a traditional spirometer and does not appear to utilize machine learning for its core measurement functions, and therefore, a training set for an algorithm is not applicable.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as no training set for a machine learning algorithm was used or described.
§ 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).