Search Results
Found 1 results
510(k) Data Aggregation
(147 days)
EASY ON-PC SPIROMETER
The ndd Medical Technologies Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Spiroson-AS). The Easy on-PC software is installed on a Windows based PC or laptop computer to which the Easy on-PC sensor is connected.
In order to conduct simple diagnostic spirometry testing, the Easy on-PC sensor is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (spirette).
The sensor is an ultrasound flow sensor that measures the transit-time to determine flow velocity, volume and molar mass of the gas. The collected data is transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
The document focuses on the Easy on-PC Spirometer, and the primary performance evaluation mentioned is against standards for diagnostic spirometry.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Adherence to American Thoracic Society (ATS) recommendations for accuracy and precision in diagnostic spirometry tests. | "Dynamic wave form testing confirmed that the Easy on-PC Spirometer meets recommendations published by the American Thoracic Society (ATS) for accuracy and precision for the intended diagnostic spirometry tests." |
| Conformance with IEC 60601-1 requirements for electrical safety. | "The device was tested to demonstrate conformance with IEC 60601-1 and IEC 60601-1-2 requirements for electrical safety." |
| Conformance with IEC 60601-1-2 requirements for electrical safety (specifically electromagnetic compatibility). | "The device was tested to demonstrate conformance with IEC 60601-1 and IEC 60601-1-2 requirements for electrical safety." |
| Biocompatibility of materials used. | "The materials used meet the requirements for biocompatibility in accordance with ISO 10993." |
| Software verification and validation to meet specified criteria. | "Software verification and validation revealed that the Easy on-PC software meets the specified criteria." |
| Substantial equivalence to the predicate device (Brentwood/Midmark Diagnostics IQmark Digital Spirometer) in terms of technological characteristics, specifically an equivalent level of accuracy for flow measurement. | "The device has the same technological characteristics as the predicate devices except for the use of ultrasonic technology for flow measurement. Testing was conducted that demonstrates this method of flow measurement is as accurate as the methods used in predicate devices and therefore substantially equivalent to the predicate device." (The ATS compliance listed above implicitly supports this, as the predicate would also need to meet such standards.) |
2. Sample Size for the Test Set and Data Provenance
The document mentions "Dynamic wave form testing" to confirm ATS recommendations. This typically involves using a calibrated syringe or similar device that generates known flow-volume curves. The document does not specify the sample size (e.g., number of waveforms, number of tests, specific range of volumes/flows tested) or the data provenance in terms of patient data (e.g., country of origin, retrospective/prospective). The testing described is a technical performance validation rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For technical performance testing against ATS standards, the "ground truth" would be established by the precise and calibrated nature of the waveform generation equipment, not by clinical experts making diagnoses.
4. Adjudication Method for the Test Set
This information is not mentioned in the document, as the testing described is primarily technical performance validation against a standard, not a subjective clinical assessment requiring adjudication.
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
A MRMC comparative effectiveness study was not performed, nor is it applicable to this device. This device is a diagnostic spirometer, which directly measures physiological parameters (flow, volume). It does not involve human "readers" interpreting output in the way an AI-assisted diagnostic imaging system would. The "assistance" it provides is the measurement itself and presentation of results, not interpretive aid to a human reader in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary performance evaluation described is "standalone" in the sense that the device itself (the sensor and software) takes measurements and processes them to produce results in accordance with ATS standards. There's no mention of a human-in-the-loop performance evaluation in the context of improving diagnostic accuracy; rather, the device is the diagnostic tool.
7. The Type of Ground Truth Used
The ground truth used for the primary performance claim (meeting ATS recommendations) was established by standardized, simulated waveforms generated by "dynamic wave form testing." This is a form of technical or engineering ground truth based on established physical and physiological standards for spirometry. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not describe any "training set" as this device is a measurement instrument based on physical principles (ultrasound transit-time) and does not rely on machine learning or AI models that require data training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of ground truth for such a set is not applicable to this device.
Ask a specific question about this device
Page 1 of 1