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The Spirolab and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.

The device carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with predicted values and percentage deviations calculation of the main parameters plus Flow/Volume and Volume/time curves and the interpretation of the measured values following the international spirometry standards (ATS/ERS).

The provided document describes the MIR Spirolab and Spirolab II, which are spirometers intended to measure lung function. The document details the device's technical characteristics, intended use, and the testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested to ensure it performs safely and accurately within its intended environments and that it complies with American Thoracic Society (ATS) Spirometry standards. This implies that the ATS standards define the acceptance criteria for spirometry performance. However, the specific quantitative acceptance criteria (e.g., accuracy ranges for FVC, FEV1, etc.) and the precise reported device performance against these criteria are not explicitly listed in a table format.

The document generally states: "The results demonstrates that the MIR Spirolab and Spirolab II are durable, safe (operator and patient), and perform within its specifications."

Without explicit quantitative values from the ATS standards and the device's exact measurements against them, a detailed comparison is not possible from this document alone.

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

The document states: "Spirometry testing was performed according with American Thoracic Society (ATS) Spirometry standards." However, it does not provide any details regarding:

• The sample size used for the spirometry performance testing.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document. For a spirometer, the "ground truth" would generally refer to an established reference standard for lung function measurements, often using highly calibrated and accurate spirometry equipment, overseen by qualified personnel. The document only mentions compliance with ATS standards, which inherently include best practices for measurement.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication typically applies when multiple human readers interpret data, which is not directly applicable to the automated measurements of a spirometer in the same way.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is relevant for AI systems that assist human readers in interpreting complex images or data, which is not the primary function of a spirometer. The device is a standalone measurement tool.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The document explicitly states: "Testing was done to ensure that the MIR Spirolab/Spirolab II would perform safely and accurately within the environments for which it is to be marketed." And "Spirometry testing was performed according with American Thoracic Society (ATS) Spirometry standards." This indicates that the algorithm and hardware's performance were evaluated directly against established standards.

7. Type of Ground Truth Used

The ground truth used for performance comparison was based on American Thoracic Society (ATS) Spirometry standards. This implies that the device's measurements were compared against accepted reference ranges and accuracy requirements defined by these international standards, which are expert consensus-driven.

8. Sample Size for the Training Set

The document does not mention a training set. This is because the MIR Spirolab and Spirolab II are described as using "the same algorithms for spirometry parameters calculation" as a predicate device and performing standard spirometric tests (FVC, VC, MVV). This suggests a rule-based or established algorithmic approach rather than a machine learning model that would require a dedicated training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set or machine learning algorithms, the establishment of ground truth for a training set is not applicable in this context. The device relies on established scientific principles and algorithms for spirometry.

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