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SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.

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This document is a 510(k) premarket notification decision letter for a Peak Flow Meter, not an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, such as details on a test set, expert ground truth, MRMC studies, or training data. The document focuses on regulatory compliance and substantial equivalence to predicate devices for a physical medical device.

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Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

Aluna 2 consists of three main components:

• A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth.
• A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume.
• An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.

The provided text is a 510(k) summary for the medical device Aluna 2, a peak flow meter for spirometry. It compares the Aluna 2 to its predicate device, the original Aluna, and details the non-clinical testing performed to establish substantial equivalence.

However, the document explicitly states: "Clinical testing was not required." This means there was no clinical study conducted involving human subjects to directly prove the device meets acceptance criteria for improved human reader performance with AI assistance, or standalone performance against clinical ground truth.

Therefore, many of the requested points regarding acceptance criteria and study design for clinical or AI-driven performance cannot be answered from the provided text, as this type of study was not performed. The device's substantial equivalence was demonstrated through non-clinical bench testing and adherence to standards for accuracy, safety, and software.

Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, focusing on the technical specifications and non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The acceptance criteria are derived from the specified accuracy, linearity, repeatability, and impedance/resistance limits required by the "2019 ATS Update v. 2005 ATS Guidelines" and ISO standards. The reported device performance is implicitly demonstrated by the statement: "The results of these tests indicate that Aluna 2 is substantially equivalent to the predicate device." and the fact that it tightened some specifications compared to the predicate.

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This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.

The device is made up of two elements – the Electronic Peak Flow Meter and a Mobile Medical Application for smartphones that communicate via Bluetooth. The device is a portable device that can measure the Peak Expiratory Flow (PEF). The Electronic Peak Flow Meter consists of the main unit, turbine, and blowing mouthpiece.

Electronic Peak Flow Meter software is embedded in the main control unit, which is used to control the whole system of operation. After compiling, the program is solidified into the hardware. The combination of software and hardware realizes the functions for electronic peak flow meter.

When Electronic Peak Flow Meter connected to APP of communication devices (such as a mobile) through Bluetooth. The changes of the patient's PEF data within one week can be monitored by APP, so that it is more convenient to monitor the respiratory health status.

This document is a 510(k) premarket notification for an Electronic Peak Flow Meter (model DL-DF01). It states that performance testing was conducted according to the ATS/ERS Task Force: "Standardisation of lung function testing - Standardisation of spirometry 2005" to evaluate accuracy and repeatability of PEF measurements.

Here's a breakdown of the requested information based on the provided text, recognizing that some details directly related to the study's execution and ground truth might not be explicitly stated in this high-level summary:

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

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This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.

The Peak flow meter is composed of Main Unit and Mouthpiece.
Mouthpiece: Mouth blowing.
Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit.
The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.

The provided document describes the Shanghai Sonmol Medical Equipment Co., Ltd. Peak Flow Meter (models SMPF-2S, SMPF-3A) and its substantial equivalence to a predicate device. Below is a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to performance tests conducted according to the American Thoracic Society Standard of Spirometry (2005 Revision). The acceptance criteria are implicit in the accuracy specifications, which are compared to the predicate device.

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

The document does not explicitly state the sample size for the performance test set. It mentions "Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance of the device according to American Thoracic Society Standard of Spirometry (2005 Revision)."

The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. However, based on the context of a 510(k) submission, these would typically be controlled laboratory or simulated environment tests, not involving human patient data collection in a clinical setting in the same way a clinical trial would.

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. The performance tests appear to be based on engineering and standardized testing rather than expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1, none) are not applicable or mentioned as the testing performed is based on direct measurement validation against established standards for spirometry devices, not interpretation by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting images or data.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While not an "algorithm" in the AI sense, the performance tests (accuracy, repeatability, range) are essentially standalone studies of the device's measurement capabilities. The device is intended for direct measurement by the patient/user, not for interpretation by a human-in-the-loop in a collaborative diagnostic setting.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be based on:

• Established physical standards: The American Thoracic Society Standard of Spirometry (2005 Revision) provides the specifications for expected performance.
• Reference measurements: The accuracy and range are compared against predicate and reference devices, implying a standard of truth is upheld by these devices or by the testing methodologies described in the ATS standard.
• Engineering specifications: The device is tested against its own design specifications and regulatory standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a hardware measurement tool; it does not involve a "training set" in the context of machine learning algorithms.

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

This information is not applicable and not provided, as there is no machine learning training set for this device.

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Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.

The device is designed for children greater than five years of age, adolescent and adult subjects.

Safey Peak Flow Meter is an over-the-counter medical device to help respiratory patients keep track of their lung health. This device measures Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). Safey Peak Flow Meter is a pocket device intended for home use and operates on two AAA type standard alkaline batteries.

Safey Peak Flow Meter works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to PEF and FEV1. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.

The provided text describes the Safey Peak Flow Meter and its associated mobile application, which appears to be a Class II medical device intended for home use to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). The document K200832 details the device's substantial equivalence to a predicate device, Smart One (K181666).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Safey Peak Flow Meter are primarily derived from international standards and guidance documents, particularly those related to accuracy for spirometry devices.

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

The provided summary does not explicitly state the sample size used for the primary accuracy testing of the device. It mentions that the device was "tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry -2005'".

• Sample Size: Not specified in the provided document for the "Flow/Volume Simulator" test.
• Data Provenance: The document implies that the testing was conducted in India by the manufacturer Safey Medical Devices Pvt Ltd as the company is based there. The nature of the testing with a simulator indicates it is a prospective test (performed specifically for this submission).

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

For the accuracy testing against ATS/ERS standards using a Flow/Volume Simulator, the "ground truth" is established by the calibrated output of the simulator itself, which is designed to produce precise, known flow and volume profiles. Therefore, no human experts were used to establish ground truth for this specific performance test. The standard itself (ATS Standardization of Spirometry -2005) provides the expert consensus on what constitutes accurate spirometry measurements.

4. Adjudication Method for the Test Set

As the accuracy testing was conducted against a Flow/Volume Simulator, which provides a definitive and calibrated reference, no adjudication method involving human reviewers was necessary or applicable. The device's measurements were compared directly to the simulator's known outputs.

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 MRMC comparative effectiveness study was done or reported in the provided document. The Safey Peak Flow Meter is a direct measurement device, not an AI-assisted diagnostic tool that interprets complex medical images or signals requiring human expert review. Its performance is evaluated based on its accuracy in measuring PEF and FEV1 against a calibrated standard.

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

Yes, the primary performance testing (accuracy of PEF and FEV1 measurements) was a standalone algorithm-only performance assessment. The device, through its embedded algorithm, calculated PEF and FEV1, and these measurements were compared against the outputs of a Flow/Volume Simulator. This evaluation did not involve a human in the loop for the actual measurement determination. The device's mobile app displays these results to the user, but the core measurement is standalone.

7. The Type of Ground Truth Used

The ground truth used for the accuracy of PEF and FEV1 measurements was calibrated output from a Flow/Volume Simulator, defined by the American Thoracic Society (ATS) Document "Standardization of Spirometry -2005" standards.

8. The Sample Size for the Training Set

The provided document does not detail any machine learning or AI model training for the core PEF and FEV1 measurement function, nor does it specify a training set size. The device operates on an "infrared interrupt concept" to measure the rotation of a vane within a turbine, which is a physical principle rather than a data-driven AI model in the traditional sense. While there is software in the device and app, it appears to be deterministic for calculations and data management, and the document focuses on software verification and validation rather than training data.

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

Since no specific training set for a machine learning model is mentioned for the direct measurement function, the concept of "ground truth for the training set" as it relates to AI models is not applicable in this document. The ground truth for the device's operational accuracy relies on the physical principles and calibration against the ATS standards via the simulator.

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Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.

Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Aluna device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the technological differences (rechargeable battery, cloud data storage, game function) "have undergone testing to ensure the device is as safe and effective as the predicate" and that "non-clinical performance bench testing including FEV1/PEF measurement accuracy and repeatability per 2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" was performed. While the specific numerical performance results are not explicitly listed in a separate "reported performance" column, the conclusion section states that "performance characteristics for the proposed Aluna are assessed to be substantially equivalent to the predicate device," implying that the device met these stated accuracy criteria.

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

The provided FDA 510(k) summary does not specify the sample sizes used for the FEV1/PEF measurement accuracy and repeatability testing. It only mentions that these tests were performed as "non-clinical performance bench testing."

Regarding data provenance, the document does not explicitly state the country of origin or if the data was retrospective or prospective. Given it's a bench test, the data would be generated in a controlled laboratory environment.

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

The document does not mention the use of experts to establish ground truth for the test set. For FEV1/PEF accuracy testing, the "ground truth" is typically established by comparing the device's readings against a highly accurate standard spirometer calibrated to known volumes and flows, or established physical simulators that produce precise airflow patterns. This is a technical measurement, not an expert interpretive judgment.

4. Adjudication Method for the Test Set

Not applicable. The accuracy testing described is a technical comparison against a standard, not an interpretive task requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The Aluna device is a peak-flow meter, which measures physiological parameters. Its effectiveness is assessed through accuracy and repeatability against established standards, not through human reader interpretation of images or data. Therefore, a study comparing human readers with and without AI assistance is not relevant to this type of device.

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

Yes, a standalone performance assessment was done. The FEV1/PEF measurement accuracy and repeatability testing assesses the algorithm's ability to accurately measure lung function parameters by itself, without human intervention in the measurement process (though a human operates the device).

7. The Type of Ground Truth Used

For the FEV1/PEV measurement accuracy and repeatability testing, the ground truth would be established by:

• Highly accurate standard spirometry equipment or flow/volume simulators: These devices are precisely calibrated and serve as the reference standard against which the Aluna device's measurements are compared. The "2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" explicitly details the methods and standards for this type of testing, which involves comparing the device's output to known, accurate flow and volume signals.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. The Aluna is a medical device for measuring physical parameters, not an AI model that learns from a dataset in the traditional sense (e.g., machine learning for image classification). While there might be internal algorithms for signal processing or data analysis within the device, the summary does not detail the development or validation of such algorithms using a distinct training set. The emphasis is on the device's performance against established physical measurement standards.

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

Not applicable, as a traditional "training set" and associated ground truth establishment (as seen in AI/ML contexts) are not described for this device in the provided document. The device's performance is validated through specific bench testing against established physical and physiological measurement standards.

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This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.

The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.

The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.

The provided text describes the acceptance criteria and a study for the Smart Peak Flow Meter (Model: B1).

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)

• Performance Test (Accuracy, Repeatability, Flow Resistance): The document states "All of the tested parameters meet the requirements in the standards," but it does not specify the sample size used for the performance testing.
• Human Factor Engineering Study:
  • Sample Size: 20 participants
  • Data Provenance: Not specified, but likely a prospective study conducted for regulatory submission.

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)

The document refers to conformance with the American Thoracic Society (ATS) Standard 2005 Revision for performance testing. For such standards, the "ground truth" is typically defined by the standard's specifications and measurement methods using reference equipment. No information is provided about human expert involvement in establishing a ground truth for the performance test itself. For the human factors study, the "ground truth" would be the observed user interaction and satisfaction, not expert medical opinion.

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

Not applicable. The performance testing relies on comparison to standardized measurements against the ATS 2005 standard, not human adjudication of medical findings. The Human Factor study measures user performance and feedback, not a diagnostic outcome requiring adjudication.

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

Not applicable. The device is a "Smart Peak Flow Meter" for spirometry, which directly measures physiological parameters (PEF and FEV1). It does not involve "human readers" or AI assistance in interpreting images or data in a way that an MRMC study would be relevant.

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

The primary performance tests (accuracy, repeatability, flow resistance) are effectively standalone tests of the device's measurement capabilities against a standard. The human factors study evaluates the user interface and overall device usability for human users, making it a human-in-the-loop evaluation for that aspect. However, the core measurement functionality is standalone.

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

The ground truth for the performance tests (PEF and FEV1 accuracy) is based on the American Thoracic Society (ATS) Standard 2005 Revision. This standard defines the acceptable range and methodology for measuring these physiological parameters, likely involving calibrated reference equipment.

8. The sample size for the training set

Not applicable. The device is a measurement device for spirometry, not a machine learning or AI-driven diagnostic tool that requires a "training set" in the conventional sense.

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

Not applicable, as there is no "training set" in the context of this device.

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Peak.me is intended for monitoring FEVI (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.

Peak.me is a hand-held Peak Flow Meter device that is intended for monitoring FEV1 (forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for pediatric to adult users. Peak.me is not recommended for children under 5 years of age.

Peak.me consists of a mechanical unit, which physically attaches to the user's smartphone, and a software application which analyzes the measurements and serves as a disease management platform. The device uses the smartphone's internal upper microphone as a sensor and does not include any electrical parts.

As the user exhales through the mechanical unit, it produces acoustic waves with a frequency proportional to the exhalation airflow rate, which then propagates to the smartphone's internal upper microphone.

Peak.me software application analyzes the sound and displays the results. Furthermore, the application includes a review of past measurements. It enables manual input of symptoms and medication usage and provides guidance for correct usage and more.

The provided text describes the 510(k) summary for the "Peak.me" device, a peak-flow meter for spirometry. The document focuses on demonstrating substantial equivalence to a predicate device ("Wing Smart FEV1 and Peak Flow Meter," K152276) rather than a comprehensive de novo validation study. Therefore, some of the requested information regarding detailed study methodology (e.g., sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies) is not explicitly present.

However, based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Peak.me device are primarily based on the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update for accuracy and precision.

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

• Test Set Sample Size: The document does not explicitly state a specific "test set" sample size for either the accuracy/precision validation or the other performance tests. The performance data section broadly indicates that "Lab performance tests, design validation and software verification and validation tests were conducted."
• Data Provenance: The studies were laboratory-based performance tests, not clinical studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable. The device validation included testing with specific smartphone models: Samsung Galaxy S6, Samsung Galaxy S6 edge, Samsung Galaxy S7, and Samsung Galaxy S7 edge.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The performance data describes lab tests against a known standard (ATS 1994 Update), which would typically be measured using calibrated equipment rather than expert consensus on medical images or patient data.

4. Adjudication Method for the Test Set

This information is not provided as the device's validation was based on objective performance measurements against a standard, not expert review or adjudication of data points.

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 performed. The document explicitly states: "No clinical study was conducted. Peak.me has the same intended use, clinical indication and technology and no clinical studies were necessary to show substantial equivalency with its predicate device."

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

The performance data primarily focuses on the standalone mechanical unit's ability to accurately measure PEF and FEV1 when connected to a smartphone and using the application. The measurements themselves are generated by the device's mechanism and software analysis of the acoustic signal. While the user interacts with the device, the core performance validation (accuracy of measurements) is essentially standalone performance against a gold standard.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation was based on objective measurements against the accuracy and precision requirements defined by the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update. This implies the use of calibrated spirometry equipment as a gold standard for comparison during lab testing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Peak.me device is a mechanical unit that uses a smartphone's microphone to derive measurements through physical principles (acoustic waves proportional to airflow). It is not an AI/machine learning device that requires a "training set" in the conventional sense for model development. The software "analyzes the sound and displays the results" based on established algorithms for converting acoustic signals to flow rates and volumes, not via a learned model from a dataset.

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

This information is not applicable as there is no mention of a training set for an AI/machine learning model. The device's operation is based on physical principles and signal processing, not a trained statistical model.

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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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