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The Surveyor Telemetry Central Station is designed to monitor up to 24 adult patients during cardiovascular problematic situations, through ambulatory transmitter sources. When used as a Telemetry Central Station System, Surveyor Central is designed to work with ECG only or multiparemeter transmitters for ECG and SpO2. For each patients ECG waveforms, HR, ST values and other parameters (if available) will be displayed.

The Mortara Surveyor Central Telemetry System is intended for centralized ECG monitoring of hospital patients connected to telemetry transmitters such as the Mortara X12 Ambulatory Telemetry Transmitter (K974149), (presently marketed as the X12+), or other compatible telemetry transmitters. Patients are (101-140), (produkt) manoving in a defined area, of a variable size depending on layout and thickness of walls. In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs.

The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Indications for Use:

The Surveyor Central Telemetry System is indicated for use:

• ECG monitoring of adult patients in Coronary Care Units, Step-Down Units, Emergency . Departments. It is not designed for use in highly invasive environments, such as an operating theatre.
• Centralized ECG monitoring through a telemetry network of adult palients. Continuous analysis is . provided for all connected patients. It is not designed for use in highly invasive environments, such as an operating theatre.
• Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an . audio-visual alarm according to the alarm profile.
• . Chest Pain Evaluation.
• Evaluation of adult patients with pacemakers. .
• Evaluation of a patient's response after resuming occupational activities (e.g., after . M.I. or cardiac surgery.)
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of . patients.
• Clinical and epidemiological research studies.

The Surveyor Telemetry Central Station is a diagnostic tool intended to acquire, and provide real time ECG data of patients that require ECG monitoring during cardiovascular problematic situations. The cardiac data provided is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Surveyor Telemetry Central Station will be used for centralized ECG monitoring in a telemetry system consisting of three main components: the ambulatory ECG telemetry transmitters (X12 Ambulatory Transmitters), the receivers combined with an antenna network and the Central Station software application running on a PC.

The transmitter is attached to the patient and acquires a continuous 12-lead ECG signal. The signal is A/D converted and digital data is sent to the Central Station using wireless radiofrequency communication.

The antenna network receives the data sent by the transmitters. The network delivers the signal to the receivers installed in the Central Station PC. The receivers decode the data containing the ECG waveforms and status from the transmitters.

The Central Station retrieves the data from the receivers and performs arrhythmia and ST analysis on the signal. The result of the analysis can trigger an audiovisual alarm. The priority of each arrhythmia and ST alarm is defined in the alarm profile.

When used as a Telemetry Central Station, Surveyor Central Station is designed to work with ECG only or multi-parameter transmitters for ECG and SpO2. The Central Station can simultaneously retrieve, display and analyze ECG signals for up to 24 patients.

A single patient can be selected for reviewing data in the single patient view, which includes following displayed and printed data:

• All 12 real-time ECG leads. .
• Current average and reference QRS complex with current ST levels for all leads .
• The Central Station also stores waveforms, measurement data and alarms for 72 hours. The . waveforms can be reviewed and printed

The provided text describes the Mortara Surveyor Telemetry Central Station, its intended use, and its classification, but it does not contain any information about acceptance criteria or specific studies proving device performance against such criteria.

The document is a 510(k) submission, primarily focused on establishing substantial equivalence to predicate devices and detailing the device's characteristics and intended use. It lists applicable standards (IEC 60601-1, ANSI/AAMI EC11-1991, etc.), which set general safety and performance requirements for medical electrical equipment, but it does not report any specific test results or performance metrics that would typically be used to demonstrate compliance with acceptance criteria.

Therefore, for each of your requested points, the information is not available in the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned. The device is a telemetry central station, not an AI-assisted diagnostic tool in the sense of image interpretation.

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

• Standalone Performance Study: Not mentioned or detailed. The document emphasizes that "The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel," indicating a human-in-the-loop system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not specified.

8. The sample size for the training set

• Sample Size: Not specified. No deep learning or AI model specific training is mentioned for which a training set would be defined.

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

• Ground Truth Establishment: Not specified.

In summary: The provided document is a 510(k) summary emphasizing device description, intended use, and substantial equivalence to predicate devices. It does not contain the detailed performance study results or acceptance criteria that would typically be found in a clinical validation report or similar technical documentation. The standards mentioned refer to general safety and performance, not specific performance criteria for the arrhythmia or ST analysis algorithms.

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