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The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

The document describes a 510(k) submission for the SDI AstraSonic Diagnostic Spirometer. The study performed aims to demonstrate substantial equivalence to a predicate device, the ndd Medical Technologies EasyOne Spirometer.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state acceptance criteria in a quantitative table. Instead, it describes a comparison methodology to establish equivalence. The core "acceptance criterion" is that the AstraSonic spirometer's measurement accuracy for flow should be equivalent to the predicate device.

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

• Sample Size for Test Set: The study utilized 26 waveforms. This refers to a standardized set of waveforms defined by the American Thoracic Society (ATS) for evaluating spirometer performance. These are likely simulated waveforms, not real patient data.
• Data Provenance: The 'data' (waveforms) are predefined standards from the American Thoracic Society, not originating from a specific country or collected retrospectively/prospectively. They represent a standardized, objective input for testing.

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

This information is not provided in the document. The "ground truth" for the test set (the 26 ATS waveforms) is inherent in the definition of those waveforms themselves as a benchmark for spirometer accuracy, not established by human experts in this context.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of using standardized ATS waveforms, there wouldn't typically be a need for expert adjudication in the way it's applied to, for example, image interpretation. The device's measurements would be compared against the known characteristics of the input waveforms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance is affected by an AI system. The AstraSonic spirometer is a diagnostic device for measuring lung function, not an AI system assisting human readers with clinical interpretation.

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

Yes, a standalone performance evaluation was the primary method. The study involved a "direct comparison of the Astrasonic spirometer and the predicate device... using the 26 waveforms described by the American Thoracic Society." This means the device's algorithmic and mechanical performance was tested independently against a known standard, without human-in-the-loop interaction for performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was standardized scientific benchmarks/specifications, specifically the 26 waveforms described by the American Thoracic Society.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Spirometers like the AstraSonic typically do not employ machine learning models that require "training sets" in the conventional sense. Their function relies on established physical principles (ultrasonic measurement of flow) and algorithms (to derive values from this flow).

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

This information is not applicable for the reasons stated above (no typical "training set" for this type of device).

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