(78 days)
The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. As the R-Test Evolution (previous model), this version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. The registered data could be sent by a modem or by an e-mail application software.
The R-Test Evolution 3 is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight cable which can be worn without any discomfort. The R-Test Evolution 3 is connected to the patient by the electrodes and the cable. Cardiac events are memorized by the R-Test Evolution 3 and then transferred for interpretation: either by a decoder, the Decotest to an electrocardiograph (or an ECG monitor), or to a computer, or by a cable directly to a computer. This transfer is generally done at the physician's surgery at the following visit. It can also be transferred by phone or by e-mail, by modem, either from the patient's home, or from the office of a physician working in connection with an interpretation center. The R-Test Evolution 3 can also transmit real time ECG recordings by telephone; and after reading or not read level and the R-Test Evolution 3 can continue recording any further pathological events which may occur on the same patient. Using a computer enables you to: define the conditions and criteria of the recordings to be made by the R-Test Evolution 3, to select, organize and store the patient data and the results of a procedure, and to print them using specific report parameters.
I am sorry, but the provided text does not contain any information about the acceptance criteria for the R-Test Evolution 3, nor does it describe any specific study conducted to prove the device meets such criteria.
The document primarily focuses on presenting the device for FDA clearance. It includes:
- Safety & Effectiveness Data Summary: This section describes the device, its intended use, and lists conformity to various standards (EN 60601-1, 93/42/EEC, EN 46002, ISO 9001, ISO 13485). It states that testing for conformity to these standards will be completed, reviewed, and approved prior to release, but it does not detail these tests or their results.
- FDA Clearance Letter: This letter confirms the device's substantial equivalence to legally marketed predicate devices.
- Indications for Use: This section reiterates the device's intended use.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or comparative effectiveness studies based on the information given.
§ 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).