(210 days)
The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.
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This document is a 510(k) clearance letter for the COSMED Pony FX, a pulmonary function testing system. It indicates that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the information requested in your prompt regarding:
- Acceptance criteria and reported device performance (Table 1)
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size and ground truth establishment for the training set
The document primarily focuses on the regulatory clearance process, the device's indications for use (basic lung function tests and pulse oximetry), and regulatory compliance. It does not include details about specific performance studies or the methodology used to demonstrate substantial equivalence beyond a general statement of review.
Therefore, I cannot fulfill your request for a detailed description of the acceptance criteria and study findings based on the provided text.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).