(83 days)
The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output and body temperatures.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
The Horizon SE is a modified device, a system identical to of the Horizon SE Cathlab with the addition of EtCO2 measurement.
I am sorry, but the provided context does not contain the information required to fulfill your request. The document describes a medical device, its intended use, and its 510(k) clearance, but it does not detail performance acceptance criteria or the study that proves the device meets those criteria. Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts used to establish ground truth.
- Adjudication methods.
- Details of a multi-reader multi-case comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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).