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The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO analysis.

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This document, a 510(k) clearance letter for the SIMTEC INTELLIFLOW® Respiratory Analyzer, provides limited information regarding acceptance criteria and study details. Based on the provided text, the following can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size used for the test set: Not explicitly stated. The document refers to "24 waveforms recommended by the American Thoracic Society Standard of Spirometry." It implies the device was tested against these 24 waveforms.
• Data provenance: The testing was performed at "LDS Hospital." The country of origin can be inferred to be the USA, given the FDA clearance. The study appears to be a prospective verification/validation study, as it was conducted to demonstrate conformance to a standard.

3. 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 stated. The "ground truth" for the test appears to be the defined characteristics of the ATS standard waveforms themselves, not observations by human experts. The accuracy against these waveforms was assessed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not stated. The evaluation was against a defined standard (ATS waveforms) using an LFS simulator, not through human adjudication of differing interpretations.

5. 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

• No, an MRMC comparative effectiveness study was not done. This device is a respiratory analyzer for acquiring and interpreting pulmonary function data, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance assessment was done. The "Intelliflow unit was tested... to verify that it conforms to the 24 wave forms." This implies an evaluation of the device's output against a standard without direct human intervention in the interpretation during the test. The device itself is designed to "acquire analysis and interpret pulmonary function data," suggesting its primary function is standalone interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth used was the specifications of the "24 waveforms recommended by the American Thoracic Society Standard of Spirometry" as generated by an "LFS simulator." This is an objective, standardized ground truth based on a recognized industry standard for spirometry.

8. The sample size for the training set

• Not applicable/Not stated. The INTELLIFLOW® Respiratory Analyzer described here appears to be a device for data acquisition and interpretation based on established physiological principles and algorithms, not a machine learning or AI-based device that typically requires a large training set in the modern sense.

9. How the ground truth for the training set was established

• Not applicable/Not stated, as there is no indication of a training set in the context of machine learning. The device's operation is based on conformity to a standard.

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