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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.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data. The performance evaluation was primarily conducted via bench testing using a "flow/volume Pulmonary Waveform Generator."
• Data Provenance: Not applicable in the context of patient data. The testing was conducted by FIM MEDICAL, the manufacturer. The document does not specify the country of origin of patient data, as human subjects were not used for performance validation.
• Retrospective or Prospective: Not applicable as the study was bench testing, not clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for the bench testing was established by the specifications of the "flow/volume Pulmonary Waveform Generator" and the ATS 2005 Spirometry Testing Recommendations.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no human adjudication of diagnostic findings from a patient test set. The validation was against established technical specifications and standards (ATS 2005).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not reported. The device is a diagnostic spirometer, and its performance was evaluated in terms of its technical measurement accuracy against established standards, not its ability to improve human reader interpretation of results in a clinical setting.
• Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was conducted, and the device's function does not involve AI-assisted interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, a standalone performance evaluation was conducted. The "bench testing" described in the summary represents the algorithm's (and hardware's) standalone performance. The device independently acquires, calculates, displays, and stores spirometry data. The document states:

  "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.

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