(118 days)
The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.
The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria for the "Omni III Patient Monitor".
The document is a 510(k) summary and FDA clearance letter for the Omni III Patient Monitor. It primarily focuses on:
- Intended Use: Describing what the device monitors and for whom.
- Device Description: A general overview of the device's features.
- Predicate Device: Identifying a comparable existing device (Goldway UT4000F Patient Monitor).
- Substantial Equivalence: Stating that the proposed device is substantially equivalent to the predicate device in intended use and technological characteristics.
- FDA Clearance: The actual FDA letter granting clearance for the device.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in design validation reports or clinical study summaries, which are not included in the provided 510(k) summary. The FDA clearance is based on the device being substantially equivalent to a predicate device, implying that the predicate device likely had studies supporting its performance, and the Omni III is considered to perform similarly without necessarily requiring extensive new clinical studies for this specific 510(k) clearance process.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).