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The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

The EventStation enables the physician to receive and review ECG recordings transmitted by the patient from a Reynolds CardioCall event recorder and other compatible event recorders. The EventStation consists of a personal computer with voice modem, operating under Windows 98, and special software written by Reynolds Medical Ltd. The computer is assembled by Reynolds from standard components, and has been modified so that the operating system cannot be changed and unauthorized software cannot be loaded.

The provided text describes the Reynolds EventStation ECG Trans-Telephonic Receiving System and its 510(k) submission. However, it does not include detailed acceptance criteria or a specific study proving the device meets them, as requested.

The document states that an "Equivalence test has been done on patients, to show that the EventStation is equivalent to a predicate device," but it offers no details about this test, its methodology, results, or the acceptance criteria used.

Therefore, I cannot provide the complete table and information as requested because the necessary data is absent from the provided text.

Specifically, the following information is NOT available in the document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance Data" section (6) only mentions:

• Non-clinical tests: The software was tested in accordance with EN60950, EN 55022, and EN50082, and "undergone extensive validation testing." These are standards for safety and electromagnetic compatibility, not clinical performance metrics.
• Clinical tests: "An Equivalence test has been done on patients, to show that the EventStation is equivalent to a predicate device." No details of this test are provided.

Conclusion: The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed report of clinical study design, acceptance criteria, and specific performance metrics. It indicates that an equivalence test was conducted but does not provide the specifics required to answer your questions.

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