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TTM5000 is a fully featured, non-invasive 9 Volt battery operated ECG (Electrocardiogram) Event Recorder. The intended use of TTM5000 is to record electrical heart signals (Electrocardiogram) of the patient. The recorded analog data can be transmitted over the telephone lines to a transtelephonic ECG receiving system. it is used mainly by Cardiologists and Internists to detect transient arrhythmias. The device is also called arrhythmia recorder.

TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder.

This document (K973267) is a 510(k) summary for the TTM5000 Telephonic EKG Monitor, which aims to demonstrate substantial equivalence to a predicate device (Heartrak, K960499). It does not contain a detailed study report with specific acceptance criteria and performance metrics for the TTM5000 device itself.

Based on the provided text, I can infer the following:

• Acceptance Criteria: Not explicitly stated as specific numerical thresholds (e.g., sensitivity, specificity). The acceptance here is based on substantial equivalence to the predicate device, implying that the TTM5000 must perform similarly to the Heartrak. The document highlights shared characteristics as the basis for this substantial equivalence.

• Device Performance: The document states that the TTM5000 records 40 seconds of Electrical Heart Signals (Electrocardiogram) and transmits the audible analog signal through telephone lines, with output at the transtelephonic ECG recording system being a conventional ECG display. This mirrors the stated capabilities of the predicate device.

Here's a breakdown of the requested information, with explicit notes about what is NOT available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not provided. The document does not describe a clinical study or a test set used to independently evaluate the TTM5000's performance against specific metrics. The substantial equivalence argument relies on shared characteristics and intended use with a predicate device.
• Data Provenance: Not provided. Since no specific test set is described, there's no information on country of origin or whether data was retrospective or prospective.

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

• Not applicable. As no specific test set or clinical study is described for the TTM5000 in this document, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

• Not applicable. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document describes a telephonic EKG monitor, which is a device for recording and transmitting ECG signals, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant to this submission and was not conducted.

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

• Not explicitly described. The document focuses on the device's functional equivalence to the predicate. While the device itself performs the recording and transmission automatically (standalone operation for its primary functions), there is no separate "algorithm only" performance evaluation described in the sense of a diagnostic algorithm's accuracy that would typically be evaluated standalone. The output is a "conventional ECG display," which still requires human interpretation.

7. The type of ground truth used

• Not applicable for TTM5000 performance. Since no specific study evaluating the TTM5000's diagnostic accuracy is detailed, there's no mention of ground truth (e.g., pathology, outcomes data). The "ground truth" for the 510(k) submission is that the predicate device (Heartrak) is already legally marketed and presumed safe and effective for its intended use.

8. The sample size for the training set

• Not applicable. The TTM5000 is described as an ECG event recorder and transmitter, not a device that utilizes machine learning or AI requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on the functional and technical similarities between the TTM5000 and a predicate device. It does not contain a detailed report of a clinical study or performance testing with specific acceptance criteria, sample sizes, or ground truth establishment for the TTM5000's diagnostic capabilities. The claims of safety and efficacy are general and rely on the substantial equivalence to the already marketed predicate device, as well as adherence to Good Manufacturing Procedures.

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