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The iT20 telemetry transmitter is intended to monitor physiological parameters including: ECG, oxygen saturation of arterial blood (SpO2) and pulse rate (PR) for adults and pediatric patients. The iT20 requires the EDAN MFM-CMS (Central Monitoring Station) to provide full functionality of the device.

The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).

iT20 collects physiological parameters by ECG cables and SPO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SPO2 and PR.

The ECG monitor samples small voltages of about 1 mV that appear on the skin as a result of cardiac activity. Three or five electrodes arranged in standard configurations called leads, are placed on the skin to sense these voltages. At least two electrodes are required for an ECG leads; The third electrode is used as a reference to reduce electrical interference. Each lead presents a heart, producing ECG waveform whose P waves, QRS complex, and T waves vary in amplitude and polarity. The signals from the different leads provide the cardiologist with a complete representation of the electrical activity of the heart, including the HR, which is interpreted as the R-to-R Interval. The timing and wave shape of ECG provides information on whether the patient's HR is characterized by arrhythmia or other altered functions requiring treatment. The ECG is also used to monitor the effects of infusing antiarrhythmia or cardiotonic agents.

SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.

The provided text describes the Edan Instruments, Inc. Telemetry Transmitter, model iT20, and its substantial equivalence to predicate devices, but it contains limited information regarding a formal acceptance criteria study of the device's performance measures directly. Instead, it focuses on comparing the proposed device's specifications to those of predicate devices and adherence to various safety and performance standards.

The document indicates that "Bench testing was conducted on the iT20 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1-8: 2006, IEC 60601-2-27: 2011, IEC 60601-2-49: 2011, ISO 80601-2-61: 2011, ANSI/AAMI EC57: 2012 standards for performance effectiveness." This implies that the acceptance criteria are met by complying with these standards.

Here's an attempt to extract the requested information based on the provided text, while noting significant gaps where the information is not present:

Acceptance Criteria and Device Performance Study for Edan Instruments, Inc. Telemetry Transmitter, model iT20

The evaluation of the Edan Instruments, Inc. Telemetry Transmitter, model iT20, primarily relies on demonstrating substantial equivalence to predicate devices and compliance with relevant international standards for safety and performance. No specific stand-alone study "proving" the device meets acceptance criteria as a new AI/algorithmic device with defined accuracy metrics is detailed, rather its performance is compared to established standards and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the operational parameters and performance accuracy specified in the comparison table with the predicate device (TMS-6016) and compliance with the listed standards.

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

The document does not specify a distinct "test set" in terms of patient data or case numbers. The performance data is stated to be derived from "Bench testing" and "non-clinical data" used for substantial equivalence determination and compliance with standards. There is no mention of geographical origin or whether data was retrospective or prospective in the context of device performance testing.

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

This information is not provided. The compliance with standards and comparison to predicate device specifications serves as the basis for performance claims, rather than a specific expert-adjudicated ground truth for a test set.

4. Adjudication method for the test set

This information is not provided, as no expert-adjudicated test set is detailed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a telemetry transmitter for physiological parameters, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The document implies that the device's functional performance (e.g., accuracy of HR and SpO2 measurement) was assessed in a standalone manner during bench testing and compliance evaluations against technical standards. The context is measuring physiological parameters rather than an algorithm producing diagnostic outputs.

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

For the performance metrics listed (e.g., HR accuracy, SpO2 accuracy), the ground truth is implicitly defined by the measurement standards and methodologies used in bench testing to assess compliance with the specified accuracy ranges (e.g., using calibrated simulators for vital signs).

8. The sample size for the training set

This information is not applicable and not provided. The device described is a hardware telemetry transmitter with embedded software for physiological parameter monitoring, not a machine learning or AI model that typically requires a distinct training set.

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

This information is not applicable and not provided, as the device is not described as involving machine learning or AI that would require a ground truth for a training set.

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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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The T12S Telemetry Transmitter is a non-invasive prescription device

• indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of real-time electrocardiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring.
• indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
• The pulse oximetry sensor is indicated for use for continuous or spot monitoring of noninvasive arterial oxygen saturation monitoring.
• indicated for use on hospital patients of any age where ambulatory monitoring of ECG and SpO2 data is done (e.g. patients in Coronary Care Units, Step-Down Units, Emergency Departments, stress testing or rehabilitation departments).
• It is not designed for out of hospital transport.
• It is not designed for use in highly invasive environments, such as an operating theatre.

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

The T12S and T12 Telemetry Transmitters are non-invasive prescription devices positioned for typical use within a clinical setting of ambulatory patients in a centralized monitoring system or other clinical settings where such telemetry is used. The Telemetry Transmitters are patient-worn diagnostic tools intended to acquire, and transmit real time ECG and SpO2 data of ambulatory patients that require ECG monitoring during cardiovascular problematic situations.

When used within a compatible multi-parameter Telemetry Central Station system, the Transmitters are designed to transmit ECG data only (T12 version) or ECG and SpO2 data (T12S). The mode will be selectable, The Transmitters will typically be used for centralized ECG monitoring in a telemetry system consisting of three main components: the ambulatory ECG telemetry transmitters (T12S or T12 Transmitters), the compatible receivers combined with an antenna network and a compatible multi-parameter Central Station software application running on a PC.

The T12 incorporates wireless electrocardiographic technology to achieve acquisition and RF transmission of simultaneous real-time 12-lead ECG data with diagnostic quality to a Mortara receiver module while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals to a compatible monitoring device where the signals are displayed, without direct connection to an electrocardiograph.

The T12S integrates wireless electrocardio and pulse oximetry technology in one device to achieve real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality and pulse oximety measurement values and waveform data to a Mortara receiver module while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals and pulse oximetry measurement to a compatible monitoring device where the signals are displayed without direct connection to an electrocardiograph or separate pulse oximeter device. The T12/T12S affords the patient complete freedom of movement. Unlimited range can also be obtained with the addition of Mortara antenna network units.

T12 / T12S Transmitters are designed to work with real-time efficiency within a multiple transmitter environment without interferences. The individual transmitter can be configured on one of 256 specific channels and allows the user to increase or decrease the channels until the desired one is selected. A design option will allow the user to set the patient cable to 5 or 10 lead-wires.

The unit operates from a single "AA"-type battery and has an internally integrated antenna which is not removable or accessible. It contains an LCD that is used for setup and status. During setup, the user can configure the unit to transmit ECG waveforms and SpO2 data, patient demographics, and other user selectable options. A language option will allow the selection of the applicable user interface language. While in normal operation, the display will show status information such as a battery gauge and lead-fail information. The user can navigate through menu options and turn the unit on and off. A front button functions as a patient alert button in normal use.

The patient hookup acquires a continuous 12-lead EGG signal. The signal is A/D converted and the digital data is sent to a compatible centralized monitor using wireless radiofrequency communication. The antenna network receives the data sent by the transmitters. The network delivers the signal to the receivers installed in a compatible Central Station PC. The receivers decode the signals and status from the transmitters for monitor display and review.

The provided text is a 510(k) Device Summary for the Mortara T12S Telemetry Transmitter. It outlines the device's description, intended use, and indications for use, as well as its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or any study data proving the device meets such criteria.

Therefore, I cannot populate the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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