(122 days)
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.
| Acceptance Criteria (Standard / Guidance) | Reported Device Performance |
|---|---|
| Volume Accuracy (ATS/ERS): 3% or 0.1 L, whichever is greater | 3% or 0.1 L, whichever is greater (Matches predicate) |
| Peak Flow Accuracy (ATS/ERS): 10% or 24 L/m (0.40 L/s), whichever is greater | 10% or 24 L/m (0.40 L/s), whichever is greater (Matches predicate) |
| Electromagnetic Compatibility (IEC 60601-1-2:2014) | Passed (Tested as per standard) |
| General Requirements for Basic Safety & Essential Performance (IEC 60601-1:2005+AMD1:2012) | Passed (Tested as per standard) |
| Usability (IEC 60601-1-6:2010, AMD1:2013) | Passed (Tested as per standard) |
| Home Healthcare Environment Requirements (IEC 60601-1-11:2015) | Passed (Tested as per standard) |
| Biocompatibility (ISO 10993-1:2009) | Passed (Tested for cytotoxicity, irritation, sensitization) |
| Software Development Life Cycle / Verification & Validation (IEC 62304 & FDA Guidance) | Passed (Software considered "moderate" level of concern) |
| FCC Part 15 Subpart B and C (Intentional/Unintentional Radiators) | Passed (Device tested as per standard) |
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.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).