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The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. The data is intended to be downloaded to an analysis software package after the recording is completed.

Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker evaluation is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician

The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance Study for Holter Recorder Cardio ID+ RZ153+

The provided document describes a 510(k) summary for a new Holter Recorder, the Cardio ID+ RZ153+, seeking substantial equivalence to a predicate device, the Holter Recorder DR180 II (K001288). The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device. The study performed is a comparison of technology characteristics to demonstrate substantial equivalence, rather than a clinical performance study with specified numerical acceptance criteria for a diagnostic outcome.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the specifications of the predicate device, and the reported device performance is the specifications of the new device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: This document does not detail a specific "test set" in the context of clinical data for performance evaluation. The study relies on a comparison of technical specifications against a predicate device. Therefore, no sample size of patient data is reported for a "test set" to confirm performance against clinical endpoints.
• Data Provenance: Not applicable for a comparative technical specification study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The study is a comparison of technical specifications, not a diagnostic performance study requiring expert ground truth on patient data.

4. Adjudication Method

• Not applicable. As described above, this is not a diagnostic performance study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document does not describe an MRMC study. The device is a Holter recorder, which captures physiological signals for later analysis by software and human readers. The study focuses on the recorder's technical equivalence to a predicate device, not on the comparative effectiveness of a human-AI workflow for diagnosis.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• No. The device itself is a Holter recorder; it "is not capable of any diagnosis nor can it provide any interpretation of the data." It only displays and stores data for later analysis by "Holter for Windows software" and the user. Therefore, there is no "algorithm only" performance reported in this submission for interpretation.

7. The Type of Ground Truth Used

• Technical Specifications: The "ground truth" in this context is the published technical specifications and performance characteristics of the legally marketed predicate device (Holter Recorder DR180 II). The new device's specifications are compared against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning model, and therefore, no training set is discussed or used.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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