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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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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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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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The intended device measures a patient's peak expiratory flow rate liters/minute.

The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.

The provided document is a 510(k) Summary for the Besmed Peak Flow Meter, seeking clearance from the FDA. It details the device's characteristics, indications for use, and a comparison to a predicate device, as well as non-clinical testing performed to demonstrate substantial equivalence.

However, this document does NOT contain information about an AI/ML-driven medical device, nor does it describe a study involving human readers, ground truth consensus, training sets, or comparative effectiveness with AI assistance.

The device in question, the Besmed Peak Flow Meter, is a mechanical, hand-held device for measuring peak expiratory flow. The performance testing discussed relates to device accuracy, repeatability, and physical durability (e.g., aging, drop test), which are standard for such mechanical instruments.

Therefore, I cannot extract the information required by your prompt because the document does not pertain to the type of device or study you are asking about (i.e., an AI/ML device study with human-in-the-loop analysis).

To answer your request, I would need a document describing the clearance or approval of an AI/ML medical device, which would include details about its acceptance criteria, ground truth establishment, training and test data, and potentially human reader studies.

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This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

MSA100BT Peak Flow Meter is a hand-held pulmonary function measuring medical device that measures patient's maximum possible exhalation which is called peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. The MSA100BT is designed for pediatric to adult patients for home use and for single user, and is intended for monitoring respiratory conditions such as asthma. The MSA100BT has an automatic memory of 250 recordings and can connect to cell phone by Bluetooth. Patients can transfer the records to phone via BLE4.0, then using app to help save and track long term. The MSA100BT is capable of measuring PEF from 50 to 900 L/min and FEV1 from 0.01 to 9.99 L. Its measuring accuracy is ± 20 L/min or ± 10% of the reading for PEF, and ± 0.050 L or ± 3% of the reading for FEV1. The MSA100BT is composed of main unit, turbine sensor, and mouth piece. After each use, the mouthpiece and turbine of the device should be cleaned by soap solution and water within 30 minutes.

The provided document is a 510(k) premarket notification for the MSA100BT Peak Flow Meter. It focuses on demonstrating substantial equivalence to a predicate device, the MSA100 Peak Flow Meter, rather than detailing a study that establishes acceptance criteria for a novel AI device and proves its performance.

Therefore, the specific information requested about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device cannot be extracted directly from this document. This document pertains to a physical medical device (peak flow meter) and its performance validation using non-clinical testing and comparison to an existing device, not an AI algorithm.

However, I can extract the performance criteria and the testing performed to demonstrate that the device complies with certain standards, which can be interpreted as fulfilling "acceptance criteria" in the context of this device's submission.

Here's the closest information I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions about AI/ML device studies, the document does not contain this information as it is not about such a device.

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for a physical device, not an AI algorithm evaluated on a data test set from specific provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for performance is established by reference standards for spirometry or laboratory tests for biocompatibility/electrical safety.
4. Adjudication method: Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
7. The type of ground truth used:
   • Performance: Reference standards specified by Standards of Spirometry (2005 Revision) and American Thoracic Society (ATS) Standard 2005 Revision.
   • Biocompatibility: Laboratory testing results against ISO 10993 standards.
   • Electrical Safety & EMC: Compliance with IEC 60601 standards.
   • Wireless: Compliance with FDA guidance.
   • Software: Software requirement specifications.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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Wing 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. Wing is not recommended for children under 5 years of age.

The Wing® Smart FEV1 and Peak Flow Meter (Wing) is an electronic peak flow monitor, that measures Peak Flow and FEV1. Wing is not recommended for children under 5 years of age.

The Wing Sensor consists of a plastic shell and a detachable electronics module. The plastic shell includes a built-in mouthpiece and an acoustic transducer. The electronics module houses a PCBA with a microphone and a 3.5mm audio cable. The audio cable is plugged into the 3.5mm audio jack (headphone jack) of a smartphone to transmit audio data to the Wing Software. The Wing Software, which includes the Wing Mobile Application (Wing App), the Wing Signal Processing Engine, and the Sparo Labs Data Management System, is used to collect, transmit, manage, store, and calculate FEV1 and Peak Flow measurements.

When taking a lung function measurement, the user launches the Wing App, which serves as Wing's user interface, on his or her smartphone and connects the Wing Sensor by plugging it into the smartphone's headphone jack. The Wing App prompts the user to perform the lung function test after the user has indicated that they would like to take a lung function measurement. As the user blows through Wing Sensor, the acoustic transducer induces oscillations in the airstream and an acoustic tone is created by the airstream. The microphone, located in the electronics module, detects this acoustic tone. The frequency of the acoustic tone (i.e. the number of oscillations) is proportional to flow rate of the air as it passes through the acoustic transducer. With flow rate and correspondent time, the FEV1 can be calculated. Wing is provided non-sterile.

Here's a breakdown of the acceptance criteria and the study information for the Wing Smart FEV1 and Peak Flow Meter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated as human subject data was not used for the primary performance assessment. The "test set" for the primary performance claim was a set of "ATS 24 and 26 Standard Waveforms."
• Data Provenance: The standard waveforms are theoretical or simulated data generated by a "pulmonary waveform generator" to represent various flow patterns. This is a controlled, synthetic environment, not real-world human data.

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

• This information is not applicable as the ground truth for the primary performance testing (accuracy and precision of FEV1 and PEF) was based on ATS Standard Waveforms, which are established industry standards rather than expert consensus on individual cases.

4. Adjudication method for the test set:

• This information is not applicable as human readers or experts were not used to assess the performance against the standard waveforms. The device's measurements were quantitatively compared against the known values of the standard waveforms.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. The document explicitly states: "The subject of this premarket submission, Wing, did not require animal or clinical studies to support substantial equivalence."

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

• Yes, a standalone performance assessment was done. The bench testing against ATS standard waveforms evaluates the device's (hardware and software combined) ability to accurately measure FEV1 and PEF without human interpretation or intervention in the measurement process itself.

7. The type of ground truth used:

• The ground truth for the primary performance claim (FEV1 and PEF accuracy/precision) was established industry standards (ATS Standard Waveforms).
• For biocompatibility, the ground truth was the acceptance criteria defined by ISO 10993 standards.
• For electrical safety and EMC, the ground truth was compliance with IEC 60601 standards.

8. The sample size for the training set:

• This information is not provided in the document. Software validation and verification were conducted, suggesting development and testing, but details on a "training set" (if applicable for machine learning components) are absent. Given the device's function as a measurement tool rather than a diagnostic AI, it's possible a traditional "training set" in the machine learning sense wasn't used, or not deemed relevant for this submission.

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

• As the sample size for the training set is not provided, how its ground truth was established is also not provided in the document.

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This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatic to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation which is called "peak flow" (referred to in medical terms as PEF-Peak Expiratory Flow) and "forced expiratory volume" (commonly known as FEV1) in one second. Regular monitoring of the peak flow is useful for monitoring diseases of the airways such as asthma, C.O.P.D, or chronic bronchitis, is usually used for patient home use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The sponsor has performed bench tests to demonstrate the MSA100 Peak Flow Meter performs within specifications." This suggests the testing was laboratory-based rather than involving human subjects for performance evaluation.

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. The testing appears to be based on engineering and laboratory standards, not clinical ground truth established by medical experts for individual cases.

4. Adjudication method for the test set:

Not applicable. The testing described involves bench tests against specified performance metrics and adherence to international standards, not subjective expert adjudication of results.

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. This device is a measurement instrument (Peak Flow Meter) and does not involve AI or human "readers" interpreting data in a typical MRMC study context.

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

The device is a standalone instrument for measuring PEF and FEV1. The "algorithm only" concept doesn't directly apply as it's a physical device with embedded measurement technology (turbine transducer, photoelectric conversion). The performance described is its standalone measurement accuracy.

7. The type of ground truth used:

The ground truth used for specific performance metrics (like accuracy for PEF and FEV1) would be established by reference standards or calibrated equipment used in the bench testing. For biocompatibility and electrical safety, the ground truth is adherence to the specified ISO and IEC standards.

8. The sample size for the training set:

Not applicable. This device is a hardware measurement instrument tested against established engineering and performance standards, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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