Search Results

Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

Safey Pocket Spirometer is a prescription use medical device to help respiratory patients keep track of their lung health. This device is a portable spirometer intended for above 5 years of age. Safey Pocket Spirometer is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Pocket Spirometer 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 interpretable spirometry values. 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 document, a 510(k) Summary for the Safey Pocket Spirometer, outlines the device's technical characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device (Spirobank G, K072979). While it details various non-clinical tests and adherence to standards, it does not provide acceptance criteria tables or the specific results of the ATS/ERS flow/volume simulator test in a format that directly addresses the prompt's request for "acceptance criteria and reported device performance" with specific numerical values for metrics like accuracy, precision, sensitivity, or specificity.

The document states: "The Safey Pocket Spirometer device was tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005'. The results obtained show that Safey Pocket Spirometer display results within ATS limits." This implies that the device met the ATS standards for spirometry accuracy, but the numerical acceptance criteria and the actual performance results are not explicitly tabulated.

Therefore, the following response will infer some acceptance criteria based on the comparison table and general industry standards (ATS/ERS) and report the device's performance as "meets ATS limits" where specific numbers are not provided. Much of the requested information (e.g., sample size for test/training sets, number and qualifications of experts, adjudication methods) is absent from this 510(k) summary, as these details are typically required for studies involving qualitative or diagnostic AI/ML models with human performance components, rather than a quantitative measurement device like a spirometer.

Acceptance Criteria and Device Performance for Safey Pocket Spirometer

The Safey Pocket Spirometer is a diagnostic spirometer. The primary performance evaluation for such devices revolves around the accuracy of flow and volume measurements against established standards, such as those from the American Thoracic Society (ATS) and European Respiratory Society (ERS).

1. Table of Acceptance Criteria and Reported Device Performance

Given the information provided in the 510(k) summary, the acceptance criteria are implicitly based on the ATS/ERS standards, and the reported performance is that the device meets these standards. The comparison table with the predicate device also indicates shared performance characteristics.

Note: The document only states that "The results obtained show that Safey Pocket Spirometer display results within ATS limits." It does not provide the exact numerical results for accuracy beyond stating that it meets the accepted limits.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a separate "test set" sample size in terms of human subjects or distinct spirometry measurements. The performance testing was conducted on a "Flow/Volume Simulator." The number of samples/measurements performed on this simulator is not specified.
• Data Provenance: The testing was non-clinical, done on a simulator, and focused on device accuracy rather than patient data. The device manufacturer, Safey Medical Devices Pvt Ltd, is based in Pune, Maharashtra, India.

3. Number and Qualifications of Experts for Ground Truth

This type of device (a diagnostic spirometer) does not typically require human experts to establish "ground truth" in the same way an AI/ML diagnostic imaging device would. The ground truth for spirometry measurements is established by physical standards and calibrated simulators, often traceable to national or international metrology standards. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable. As the testing was conducted on a flow/volume simulator, no human adjudication was involved in generating the "ground truth" measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a standalone measurement device, not an AI-assisted diagnostic tool designed to improve human reader performance. Its performance is validated against physical standards, not human interpretations.

6. Standalone Performance (Algorithm Only)

The provided data describes the standalone performance of the device (Safey Pocket Spirometer) and its integrated software. The device's ability to accurately measure and report spirometry values (volume, flow, etc.) is the core of its standalone performance. The testing against ATS/ERS standards on a flow/volume simulator represents this standalone (algorithm/device only) validation.

7. Type of Ground Truth Used

The ground truth used was based on physical standards and calibrated spirometry flow/volume simulators. These simulators are designed to generate precise and known flow and volume patterns, serving as the "true" values against which the device's measurements are compared. The reference for these ground truth values is the American Thoracic Society (ATS) Document "Standardization of Spirometry - 2005."

8. Sample Size for the Training Set

Not applicable/Not specified. This device operates on an "infrared interrupt" concept to measure flow and volume, which relies on physical principles and calibration rather than machine learning models that require large training data sets. Therefore, there's no "training set" in the context of an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning algorithm. The device's method of operation is based on established physics and engineering principles, not learned patterns from data.

Ask a specific question about this device