Search Results

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

Note: The document lists the predicate's accuracy as "±10 L/min or ±10%, whichever is greater" for both PEF and FEV1. For the proposed device, it only lists PEF accuracy as "PEF ± 20 L/min or PEF ± 10% of the reading," which is a different (and less stringent) accuracy specification compared to the predicate, but it does state that "Measurements of PEF meet the requirements in the standard." The exact performance values beyond meeting the standard are not explicitly detailed for the proposed device, but it explicitly states the device meets the requirements of the standard for PEF measurements for accuracy and repeatability.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "Performance testing was conducted on the Electronic Peak Flow Meter for the measurement of peak expiratory flow (PEF)."

• 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)
  Not applicable. For a peak flow meter, the ground truth is typically established by objective measurements from a calibrated spirometer/flow source, not expert interpretation.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  Not applicable. Adjudication is not typically used for objective device performance testing of a peak flow meter. Performance is compared against a reference standard.

• 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 an Electronic Peak Flow Meter, which is a measurement device, not an AI-assisted diagnostic tool requiring MRMC studies.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  The performance testing described is a standalone evaluation of the device's measurement capabilities. The text states: "Performance testing was conducted on the Electronic Peak Flow Meter for the measurement of peak expiratory flow (PEF)."

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  The ground truth for performance testing (accuracy and repeatability) of a peak flow meter is established by a reference standard, typically a highly accurate and calibrated flow generator or spirometer that simulates breaths with known PEF values. The study followed the "ATS/ERS Task Force: Standardisation of lung function testing - Standardisation of spirometry 2005" which defines the methodologies for these ground truth measurements.

• 8. The sample size for the training set
  Not applicable. This device is a measurement instrument, not an AI/ML device that requires a training set. The embedded software "is used to control the whole system of operation" and "is solidified into the hardware" after compiling.

• 9. How the ground truth for the training set was established
  Not applicable. This device is a measurement instrument, not an AI/ML device that requires a training set and corresponding ground truth.

Ask a specific question about this device