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The Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), when used in conjunction with a Spacelabs Healthcare Ultraview patient monitor and telemetry receiver, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.

The 96281 also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/ circulatory functions.

The 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

The Ultraview™ Digital Telemetry System (AriaTele) are portable, battery-powered, patient-worn transmitters that monitor electrocardiography (ECG) activity and oxygen saturation (SpO2) data (96281-C only), and transmit this information to a telemetry receiver module.

There are three (3) variants of the AriaTele:

• Model 96281-A: ECG; .
• Model 96281-B: ECG with display; and .
• . Model 96281-C: ECG and SpO2 with display.

The AriaTele is compatible with the Ultraview SL 3800-38/-39 central monitor, and the Ultraview and Ultraview SL line of bedside monitors, collectively called "monitors." The AriaTele is also compatible with the 90478 Digital Telemetry System Receiver and Receiver Housing (90479-A, 90479-B). The receiver housing is related to the central monitor. The receiver module can go in the housing or in a bedside monitor.

The AriaTele functions as part of a digital telemetry system. The digital telemetry system consists of transmitters, diversity antennas, receiver modules, and either a receiver housing or a monitor. Typically, a request comes from a monitor to obtain data from electrodes and/or remote sensors attached to a patient which are connected to the transmitter. The monitor tells a receiver what channel to begin listening on-one that matches the transmitter on the patient.

Here's a breakdown of the acceptance criteria and the study information for the Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set in the context of clinical performance or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described primarily relies on engineering and regulatory compliance standards rather than clinical data.

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

This information is not provided in the document. The device's performance is evaluated against established technical standards (e.g., IEC, AAMI) rather than through expert-adjudicated clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a clinical test set requiring expert ground truth, an adjudication method is not applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. This device is a physiological monitoring system, not an AI-driven diagnostic or interpretative tool that would typically involve human reader performance comparisons.

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

The performance testing described is essentially a standalone evaluation of the device's adherence to various engineering and safety standards. The device itself (the AriaTele Telemetry Transmitter) is the "algorithm only" in the sense that its readings and functions are validated against these technical benchmarks. There's no mention of a separate "algorithm" being evaluated beyond the integrated device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on established industry standards and regulatory guidance documents. For physiological parameters like SpO2 and PR accuracy, these standards define acceptable levels of deviation from a true reference. For electrical safety, EMC, and software, the "ground truth" is compliance with the specified test procedures and limits outlined in the relevant IEC, UL, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The AriaTele Telemetry Transmitter is a physiological monitoring device, not an AI/ML model that would typically use a "training set" of data in the conventional sense. Its functionality is based on hardware and embedded software designed to meet specific physiological measurement and transmission standards.

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

This information is not applicable and not provided, as there is no "training set" for this type of device.

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