(117 days)
The BCI® model WW1000 handheld pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians, and home users. The intended patient population ranges from infant to adult. It can be used on patients with low perfusion. The WW1000 may be used in the hospital or clinical environment, during emergency land transport, and in the home.
The BCI® model WW1000 handheld pulse oximeter is intended for spot-check applications. The WW1000 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a red LED display and an ON/OFF button. The WW1000 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective
The provided text describes the BCI® model WW1000 Pulse Oximeter, its intended use, and the performance testing conducted to support its substantial equivalence. However, it does not explicitly state specific, quantifiable acceptance criteria in the form of a table for device performance (e.g., accuracy +/- X% with Y% confidence). Instead, it refers to general performance expectations and the results of clinical desaturation studies.
Thus, I will synthesize the information provided to construct a response that best addresses your request, highlighting what is available and what is not.
Here's an analysis of the acceptance criteria and study information for the BCI® model WW1000 Pulse Oximeter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state a table of quantifiable acceptance criteria with specific thresholds for accuracy, precision, or other performance metrics. Instead, it broadly states that "Results of the three individual clinical desaturation trials indicate that the WW1000 pulse oximeter performs as intended and is safe and effective for use." and that "The Micro-power OEM board produced the same readings (within ±1 digit) in all three host devices" during comparison testing.
Without explicit acceptance criteria, it's impossible to create a direct comparison table. However, the document does imply that the device performance was deemed acceptable based on the clinical desaturation studies (Desat 24, 27, and 40) and comparison testing, which confirmed the expected functionality and consistency across different host devices.
Implied Acceptance Criterion (based on comparison testing):
- Deviation between Micro-power OEM board and host devices:
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).