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The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.

The Retrospective II is a portable ECG memory loop recorder. It is a non-critical Type II device. The device, as well as its predicate, continuously record ECG and store several minutes of the most recent data. When the patient experiences a symptom he/she presses a button which saves this stored data. The patient then calls a receiving service and transmits the data over the telephone. The service is then able to interpret or forward the data to the patient's physician. Both the Retrospective and the Retrospective II-Elite have this same operational sequence. Both devices obtained ECG data via 3 or 5 disposable surface electrodes. The ECG signals are amplified and then digitized. A microprocessor controls the sampling of the data and then stores the data in RAM. When the symptom button is pressed the most recent stored data is then saved. When the send button is presses the saved data is recalled by the microprocessor The data is then frequency modulated and used to drive a speaker. This audio data is transmitted over a voice grade telephone line to the receiving hardware. Both devices accomplish this entire process using solid-state techniques, that is no magnetic media or moving parts are employed. Both devices are powered by alkaline batteries and have no AC power connection.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Retrospective II-Elite device:

Acceptance Criteria and Device Performance

The provided document states that the Retrospective II-Elite was designed to meet the specifications suggested by the Association for the Advancement of Medical Instrumentation (AAMI) for Ambulatory ECG Monitors. It further states that "Verification testing on a sample device has shown that the Retrospective II-Elite complies with applicable AAMI performance requirements."

However, the document does not provide a specific table of acceptance criteria or reported device performance metrics. It only refers to compliance with AAMI standards in a general sense. Without the specific AAMI standards referenced (e.g., AAMI EC38, EC13), it's impossible to create a detailed table.

Based on the information given, a generalized table would look like this:

Study Information Extracted from the Text

1. Sample sizes used for the test set and data provenance:

• Test Set Sample Size: "Verification testing on a sample device". This indicates a single or very small number of devices were tested, not a large statistical sample of patient data.
• Data Provenance: The document does not specify the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). It implies the testing was done on the device's functional performance, not on patient data.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• This information is not provided. The testing described appears to be technical verification against AAMI standards, not a clinical study involving expert interpretation of ECG data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not provided. As the testing seems to be technical verification, an adjudication method for ground truth would likely not be applicable in the traditional sense.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC comparative effectiveness study was not done (or at least, not described in this summary). This refers to technical device verification, not a clinical study comparing human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm performance study was not done. The device itself is described as a "totally passive device" that "offers no diagnosis or perform any signal analysis." Its function is purely to record and transmit, with interpretation done by a "qualified technician." Therefore, there is no internal algorithm to test in a standalone manner.

6. The type of ground truth used:

• The implicitly used "ground truth" for the device's technical performance is the AAMI performance requirements for Ambulatory ECG Monitors. The device's output (amplification, digitization, storage, transmission fidelity) was compared against these technical specifications.

7. The sample size for the training set:

• This information is not applicable/not provided. The device is described as a passive recording and transmission device, not an AI or algorithm-driven device that requires a training set for model development.

8. How the ground truth for the training set was established:

• This information is not applicable/not provided for the same reason as above.

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