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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 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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"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR)

The provided text is a 510(k) clearance letter from the FDA for a medical device called "miniMAX" Peak Flow Meter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

• The FDA's decision of substantial equivalence for the "miniMAX" Peak Flow Meter.
• The regulatory classification of the device (Class II).
• General controls and potential additional controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the device: "measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma."

To answer your questions, I would need a different document, such as the actual 510(k) summary or the premarket notification submission itself, which would detail the performance data and testing conducted for the device.

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The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use.

IMI Peak Flow Meter

I am sorry, but the provided text from the FDA document does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria for the IMI Peak Flow Meter (K970507).

The document is an FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and points regarding marketing and labeling. It also includes an "Intended Use" statement. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study proving device performance against acceptance criteria. This would typically involve specific metrics like accuracy, precision, sensitivity, specificity, etc., and the results obtained.
3. Sample size used for the test set or its data provenance.
4. Number or qualifications of experts used for ground truth.
5. Adjudication method.
6. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
7. Information about a standalone (algorithm only) performance study.
8. Type of ground truth used (e.g., pathology, outcomes data).
9. Sample size for the training set or how its ground truth was established.

To obtain this information, you would typically need to consult the 510(k) summary or the full 510(k) submission for K970507, which might contain the scientific and clinical data supporting the substantial equivalence determination, including performance testing results. The provided document is only the clearance letter itself.

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