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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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iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG. respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2).

The arrhythmia detection and ST Segment analysis are intended for adult only.

The monitor is additionally intended for use during patient transport inside of the hospital environment.

The monitor is not intended for airplane, helicopter transport, home use and MRI environments.

The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment.
iM20 can be utilized in two ways, as an independent monitor and as a module of V series Patient Monitor (including models elite V5, elite V6 and elite V8). When used as an independent monitor, it can simultaneously monitor, store, review several parameters data. And transfer patient data to V series patient monitor only under the transport mode. As a highly portable monitor, its compact design makes it particularly appropriate inside hospital and vehicle ambulance transport environments.
When as a multi-measurement module, when the iM20 is directly connected to a V series patient monitor, it can provide the measurements, trends, and patient information. When connected, the V series Patient Monitor controls the connected iM20, including all alarm functionality. So no alarms are available on iM20 in such application and iM20 takes power from the V series Patient Monitor.

This document focuses on the Edan Instruments Inc. Patient Monitor, model iM20 (K152552), and its equivalency to predicate devices. It lists performance data based on non-clinical and clinical studies to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a detailed comparison table between the proposed device (iM20) and a predicate device (Philips Medizin.Systeme Boeblingen GmbH IntelliVue MP2 cleared under K102562), focusing on various physiological parameters and technical specifications. A second comparison table is provided for the reference device Edan Instruments, Inc. iM70 (K131971), specifically for PR from NIBP and CO2 function.

Since the provided text does not present a separate "acceptance criteria" table and "reported device performance" table, but rather a comparison with performance metrics of a predicate device, the following table synthesizes the information from the "Predicate Device Comparison" section to represent acceptance criteria (from the predicate) and the reported device performance (for the iM20). Differences are explicitly noted as "Different." Where the proposed device's performance aligns with the predicate, it is marked "Same."

Acceptance Criteria (Based on Predicate Device) and Reported Device Performance (iM20)

Comparison to Reference Device iM70 (Specifically for PR from NIBP and CO2 Function)

2. Sample Sizes and Data Provenance for Test Set

• Clinical Testing Sample Size: Not explicitly stated in terms of patient numbers or case count.
• Data Provenance: The NIBP clinical testing was conducted as per ISO 81060-2: 2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type." The document does not specify the country of origin for the clinical data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not provide information on:

• The number of experts used to establish ground truth for the test set.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is provided. The study focuses on the device's technical and clinical performance against standards and a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

The document primarily describes the performance of the entire "iM20 Patient Monitor device, consisting of all the modules and accessories in the system." While it details performance parameters of various physiological monitoring algorithms (ECG, NIBP, SpO2, CO2), it does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study in the detailed sense of a specific data set applied only to the algorithm for evaluation. However, the bench testing and NIBP clinical validation are evaluations of the device's inherent measurement capabilities.

7. Type of Ground Truth Used

• For ECG, RESP, NIBP, SpO2, IBP, TEMP, CO2: The measurements of these physiological parameters are compared against the expected performance defined by international standards (e.g., ISO, IEC) or against the performance of a predicate device. For NIBP, the ground truth is established through clinical validation against "automated measurement type" as per ISO 81060-2:2013, which typically involves comparison to a reference standard measurement method (e.g., auscultatory method).
• For Biocompatibility: Compliance with ISO 10993-1, (Cytotoxicity, Skin Sensitization, Skin Irritation).
• For Electrical Safety and EMC: Compliance with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2007.
• For General Performance (Bench Testing): Compliance with various IEC/ISO standards specific to each parameter.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size, as it describes a medical device clearance submission based on equivalence to predicate devices and adherence to performance standards, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established

Not applicable, as no training set is mentioned in the context of this device's submission.

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