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Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEVI (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.

Smart One is a pocket-sized system for monitoring the following respiratory parameters: PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). For each of these two parameters, the result is a number shown on the smartphone screen. PEF is also associated with a three zone monitoring system that, according to the result, may be green, yellow or red. Smart One is made up of two elements - the device and a Mobile Medical Application for smartphones (or tablets) that communicate via Bluetooth Smart 4.0.

The provided text describes specific performance tests for the Smart One device, particularly focusing on non-clinical testing. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test set sample size: Not explicitly stated for each test beyond mentioning "a Pulmonary Waveform Generator" for the performance test.
• Data provenance: The performance test was conducted "in MIR facilities" using a Pulmonary Waveform Generator. Other tests (electrical safety, EMC, mechanical durability, temperature/humidity, wireless transmission, biocompatibility, software V&V) are generally bench tests or internal company evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not specified. The tests described are primarily engineering and performance bench tests against established standards (e.g., ATS, IEC, ISO) rather than clinical evaluations requiring expert human interpretation of medical data. The ground truth for these tests would be the controlled outputs of the Pulmonary Waveform Generator or the specified limits within the engineering standards.

4. Adjudication method for the test set

• Not applicable / Not specified. As the tests are objective engineering and performance evaluations against predefined standards, an adjudication method for human interpretation is not relevant.

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. This document does not describe an MRMC comparative effectiveness study. The device is a peak flow meter for spirometry, a diagnostic tool measuring physiological parameters, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

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

• Yes, effectively. The performance tests described (e.g., "A performance test has been carried out on the bench according to the American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005' ... using a Pulmonary Waveform Generator.") are standalone evaluations of the device's accuracy in measuring PEF and FEV1. The device itself (including its internal algorithms) is being evaluated against known, controlled inputs from the waveform generator. The mobile medical application primarily displays and compares the device's output rather than performing the core measurement algorithm.

7. The type of ground truth used

• Standardized references and objective measurements:
  • For accuracy of PEF and FEV1: The "Standardization of Spirometry - 2005" document from the American Thoracic Society (ATS) and a "Pulmonary Waveform Generator" which provides known, controlled respiratory flow patterns.
  • For electrical safety and EMC: IEC 60601-1:2005 and IEC 60601-1-2:2007 standards.
  • For biocompatibility: ISO 10993-1:2009.
  • For software: FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

8. The sample size for the training set

• Not applicable / Not specified. This document describes a medical device (a peak flow meter) which is based on physical measurement principles (turbine flow meter, infrared interruption) rather than a machine learning or AI algorithm that would require a distinct "training set" in the context of deep learning. The "training" here would be the engineering calibration and firmware development of the device based on physics and physiological principles.

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

• Not applicable / Not specified. See point 8. The device operates on established physical principles for flow measurement. Its "training" or calibration would involve ensuring the sensor accurately translates physical airflow into digital values that conform to spirometry standards, likely using highly accurate reference instruments and controlled flow sources, rather than a "ground truth" derived from expert labeling of a dataset for machine learning.

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The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.

The GoSpiro is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.

The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.

It is used with the GoSpiro App display and communications software on a smartphone or tablet.

The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11.

The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and avoids the need for individual calibration prior to performing a test.

The Monitored Therapeutics, Inc. GoSpiro® is a diagnostic spirometer intended for use by adults and children over 5 years old in physician's offices, clinics, and home settings for basic lung function and spirometry testing. It is a single-patient use device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests and compliance with established standards, but it does not explicitly list quantitative acceptance criteria for each spirometry parameter (e.g., FVC, FEV1) with specific numerical ranges. Instead, it states that "The GoSpiro passed the acceptance criteria for all the listed testing requirements and specifications." and "The performance and specifications demonstrate that the devices meet the ATS 2005 requirements for pulmonary function testing." This implies that the acceptance criteria are adherence to the ATS 2005 guidelines for spirometry, and the device met these.

However, the document does provide specific performance metrics in the comparison tables, which can be interpreted as demonstrating the device's capabilities relative to its predicates and standards.

2. Sample size used for the test set and the data provenance

The document states that "ATS / ERS waveform simulator testing" was performed and passed. However, it does not specify the sample size (number of waveforms or individuals) used for this test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as this was likely a bench/simulator test rather than a clinical study with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document because the testing appears to be primarily technical/bench validation against established spirometry standards (ATS/ERS waveform simulator testing) rather than a clinical study requiring expert ground truth for diagnostic accuracy.

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

An adjudication method is not applicable or not described in the provided text, as the testing was focused on the device's technical performance against a simulator and compliance with standards, not on interpreting images or clinical outcomes that would require adjudicators.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. The GoSpiro is a diagnostic spirometer that measures lung function, not an AI-powered diagnostic system requiring human interpretation comparison.

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

The performance testing described ("ATS / ERS waveform simulator testing") represents a standalone evaluation of the algorithm's accuracy at measuring flow, volume, and time against a known standard. Although not explicitly called an "algorithm-only" study, the nature of testing against a simulator implies measuring the device's output independently. The document states that the device performed all calculations to meet ATS/ERS requirements and included quality control measurements and indices of measurement quality.

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

The ground truth for the device's performance appears to be established by ATS/ERS waveform simulator testing. This refers to a standardized set of flow-volume and volume-time curves designed to test spirometer accuracy against known, ideal physiological breathing patterns. These simulators provide a "gold standard" input against which the device's measurements are compared.

8. The sample size for the training set

This refers to a software or AI model's training data. The document does not mention a training set as the device is a hardware spirometer with embedded firmware/software for calculations, not a machine learning or AI model that undergoes a separate training phase with a distinct dataset.

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

As there is no mention of a "training set" for an AI model, this information is not applicable in the provided text. The device's functionality relies on established physiological principles and engineering specifications, validated against standardized simulator inputs.

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