(156 days)
The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing.
The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer. It is intended as a configurable, portable, noninvasive pulmonary function tester (PFT) system. These tests are suitable for both pediatric and adult patient testing.
The KoKo LEGEND is a configurable, non-invasive pulmonary function tester (PFT) testing system. It is a diagnostic spirometer.
The provided text is a 510(k) summary for the KoKo LEGEND Diagnostic Spirometer and does not contain detailed information about a specific study testing the device's performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
Instead, it declares conformity to recognized standards and lists technical specifications, which implicitly serve as acceptance criteria for a diagnostic spirometer.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
For a diagnostic spirometer, the "acceptance criteria" are primarily established by recognized performance standards. The device's "reported performance" is its technical specifications, which are implicitly stated to meet these standards.
| Acceptance Criteria (from ATS Standardization of Spirometry 1994 Update) | Reported Device Performance (KoKo LEGEND) |
|---|---|
| Appropriately calibrated (e.g., with a 3-liter syringe) | 3-liter calibration syringe |
| Resistance |
§ 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).