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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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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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