(236 days)
The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.
Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
The OneFlow FVC is a handheld, battery operated, electronic spirometer. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
The provided document describes the OneFlow FVC, a handheld electronic spirometer. The performance data section refers to adherence to the American Thoracic Society's "Standardization of Spirometery" 1994 update. However, the document does not explicitly define specific numerical acceptance criteria for this device beyond stating that "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." Therefore, a table of acceptance criteria and reported device performance with specific values cannot be fully populated from the given text.
Based on the provided information, here's a breakdown of the requested details:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as per ATS "Standardization of Spirometry" 1994 Update) | Reported Device Performance |
|---|---|---|
| Accuracy | Recommended limits for a monitoring device (as per ATS 1994 update) | "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." |
| Repeatability | Recommended limits for a monitoring device (as per ATS 1994 update) | "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." |
| Durability/Longevity | Accuracy/repeatability maintained after 3 years typical use simulation | "Testing to simulate 3 years of use did not alter the accuracy or repeatability of the device." |
Note: The specific numerical values for accuracy and repeatability limits, as defined by the ATS 1994 update for a monitoring device, are not present in the provided text. The document only confirms the device met these unstated recommendations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document mentions "testing the OneFlow FVC" but does not give a number of devices or data points in the test set.
- Data Provenance: The testing was "Non-clinical performance data" compiled by the applicant (Clement Clarke Int. Ltd) in the United Kingdom. It is a retrospective evaluation of the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The ground truth for this spirometer performance evaluation is not based on expert consensus on image interpretation or clinical diagnosis. It's based on adherence to technical standards.
- Qualifications of Experts: Not applicable. The evaluation relies on the methods described in a recognized technical standard (ATS "Standardization of Spirometery" 1994 update) rather than a panel of clinical experts establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of performance testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the device against technical standards, not on human reader performance with or without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the study evaluates the standalone performance of the OneFlow FVC device. The testing described focuses solely on the device's ability to accurately measure spirometry parameters according to the ATS 1994 update, without human interpretation in the loop as part of the performance evaluation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is based on technical standards and simulated conditions. Specifically, performance was evaluated "in accordance with the methods described in the American Thoracic Society's document 'Standardization of Spirometery' 1994 update," with a focus on meeting the "limits for a monitoring device during evaluation." Additionally, a "simulation of three years typical use" was conducted as part of the durability ground truth.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The OneFlow FVC is a measurement device, not an AI/ML algorithm that requires a training set. The device's design and calibration would be based on engineering principles and established physical processes, not a data-driven training set in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device. The device's functionality is based on its hardware design (venturi pressure system, microprocessor, sensors) and software algorithms for measurement, which are calibrated and developed according to engineering specifications and industry standards.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).