(433 days)
Diagnostic Spirometry. Patient Population: Male/Female, Podistric to Adult. Device Functionality: Diagnostic Spirometry. Spirometric Parameters: FVC, MVV, SVC, and FEF. Environment of Use: Hospital, Clinical and Home Use. Prescription device by a physician.
The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases. The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy. The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.
Here's an analysis of the provided text regarding the SpiroCard device, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Study Details for SpiroCard
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the SpiroCard. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (PFM Professional 7000) and meeting "specifications" through testing.
However, based on the description, we can infer the primary performance expectation:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (PFM Professional 7000) for measuring breathing functions. | "The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device...measures and calculates the results the same...The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy." |
| Ability to measure FVC, MVV, and SVC breathing functions accurately. | "The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms. The results of both tests supported substantial equivalence and met specifications." |
| Implied: Accuracy of measurements comparable to predicate device. | "The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy." (Suggests improved accuracy over predicate, but no specific numbers provided.) |
2. Sample Size for the Test Set and Data Provenance
The document states: "The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms."
- Sample Size for Test Set: Not specified. The exact number of waveforms generated or the duration/number of tests performed is not mentioned.
- Data Provenance: Not applicable in the traditional sense, as it was a simulated study using a Pulmonary Waveform Generator, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this study was established by the American Thoracic Society Standard waveforms generated by the Pulmonary Waveform Generator. There were no human experts involved in establishing the "ground truth" for the test set of waveforms.
4. Adjudication Method for the Test Set
None. Since the "ground truth" was derived from standardized waveforms, there was no need for human adjudication. The device's output was compared directly against the known, standardized waveform parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the technical performance of the device itself against standardized waveforms, not on how human readers interact with or are influenced by the device's output. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, a standalone performance study was done. The description of the testing against the Pulmonary Waveform Generator directly evaluates the device's (SpiroCard's) ability to measure and calculate spirometric parameters without human intervention or interpretation as part of the core measurement. The output of the device (measurements and calculations) was compared to the known values of the standard waveforms.
7. Type of Ground Truth Used
The type of ground truth used was standardized scientific waveforms (American Thoracic Society Standard waveforms).
8. Sample Size for the Training Set
Not applicable/Not specified. The SpiroCard is described as a diagnostic spirometer that measures and calculates breathing functions based on physical principles (pressure produced by a pneumotachometer, correction factors, and formulas). It does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. Its "knowledge" is embedded in its design, specific sensors, and pre-programmed algorithms/formulas.
9. How Ground Truth for the Training Set Was Established
Not applicable. As the device does not appear to use a machine learning model requiring a training set, the concept of establishing ground truth for a training set does not apply here. The device's functionality is based on established physiological principles and measurement techniques.
§ 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).