(169 days)
When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.
The Smart Wedge algorithm is designed to provide the value at end-expiration of the pulmonary artery occlusion pressure (PAOP) signal, also called pulmonary wedge pressure, pulmonary capillary wedge pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and to assess the quality of the pulmonary artery occlusion pressure measurement.
The Smart Wedge algorithm is intended to be used with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The device performance is reported for two main aspects: PAOP (Pulmonary Artery Occlusion Pressure) Identification and PAOP Measurement. The acceptance criteria can be inferred from the reported performance results and the comparison to the predicate device, especially the statement: "Results for the Smart Wedge algorithm met or exceeded predicate device performance." While explicit numerical acceptance criteria aren't listed as "targets," the provided performance values serve as the acceptable outcomes.
| Smart Wedge Algorithm Parameter | Implicit Acceptance Criteria (Target/Goal) | Reported Device Performance (Mean with 95% CI) |
|---|---|---|
| PAOP Identification | High Sensitivity (close to 100%) | Sensitivity: 100% [100, 100] |
| (based on 225 PAP waveforms) | High Specificity (close to 100%) | Specificity: 96% [92, 100] |
| High Positive Predictive Value (PPV) (close to 100%) | PPV: 95% [89, 99] | |
| High Negative Predictive Value (NPV) (close to 100%) | NPV: 100% [100, 100] | |
| PAOP Measurement | Low Mean Absolute Error (MAE) (e.g., |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).