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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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