(87 days)
The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.
The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
The PulmoTrack 5050 Wholter™ is a recording device of pulmonary sounds. The device collects the pulmonary data from 4 sensors including a sensor for ambient sounds to reduce background noise. The acquired data is filtered, undergoes A/D conversion and is stored on a flash disk. The digital data is later downloaded to a PC for analyzing using a diagnosis software package.
The PulmoTrack 5050 Wholter™ device consists of:
- . Acoustic sensors (attached to the patient using adhesive pads)
- . Tension-sensitive respiration belt
- . Ambient microphone
- A/D data acquisition device .
- . Firmware and Flash memory
- . USB cable
The provided text describes the PulmoTrack 5050 Wholter™ device, a recording device for pulmonary sounds. However, the document explicitly states that the device itself does not perform diagnosis and therefore does not require clinical testing for its own function. Its safety and efficacy were proven by bench performance tests.
The document mentions that the device is "used in conjunction with an analysis software package that is used by the PulmoTrack 2010 (WIM-PC) (K071955), which has been validated by performance tests for performing diagnosis of the recording." This implies that the diagnostic aspect (which would typically involve acceptance criteria, ground truth, and clinical study details) falls under the "PulmoTrack 2010 (WIM-PC)" software, not the PulmoTrack 5050 Wholter™ recording device itself.
Therefore, based on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and a study that proves the device meets those criteria, as the PulmoTrack 5050 Wholter™ is presented as a data acquisition and recording device, not a diagnostic device with associated performance criteria for diagnosis.
The only "performance data" mentioned for the PulmoTrack 5050 Wholter™ is:
- Performance Testing - bench tests: "The PulmoTrack 5050 Wholter underwent validation testing to ensure performance according to its specifications... All tests demonstrated satisfactory results." No specific acceptance criteria or results are provided for these bench tests.
- Performance Testing - clinical study: "The PulmoTrack 5050 Wholter™ itself does not perform diagnosis and therefore does not require clinical testing. The safety and efficacy of the PulmoTrack 5050 Wholter™ was proven by bench performance tests."
To fulfill your request for acceptance criteria and a study proving their achievement, more information would be needed about the "PulmoTrack 2010 (WIM-PC)" software, which is responsible for the diagnostic analysis.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).