(295 days)
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.
| Performance Metric (Acceptance Criteria per Standards/Predicate Comparison) | Reported Device Performance (iT20) |
|---|---|
| ECG Function: | |
| HR Calculation Range (Adult) | 15 bpm to 300 bpm (Similar to predicate) |
| HR Calculation Range (Pediatric) | 15 bpm to 350 bpm (Improved range compared to predicate's 15-300 bpm) |
| HR Accuracy | ±1% or 1 bpm, whichever is greater (Same as predicate) |
| HR Resolution | 1 bpm (Same as predicate) |
| ECG Sensitivity | ≥300 µVPP (Improved sensitivity compared to predicate's ≥200 µVPP) |
| ST Numeric Range | -2.0 mV to +2.0 mV (Same as predicate) |
| ECG Bandwidth (Diagnosis) | 0.05Hz to 150Hz (Improved range compared to predicate's 0.1 Hz to 40 Hz) |
| ECG Bandwidth (Monitor) | 0.5Hz to 40Hz (Same as predicate) |
| ECG Bandwidth (Surgery) | 1Hz to 20Hz (Same as predicate) |
| CMRR (Diagnosis) | >95dB (the Notch filter is off) (Similar to predicate's 105dB) |
| CMRR (Monitor/Surgery) | >105dB (the Notch filter is on) (Similar to predicate's 105dB) |
| Pace Pulse Indicator (Amplitude, Width, Ascending Time) | Meets IEC 60601-2-27: 2011, Sect. 201.12.1.101.12 requirements for specific ranges (Improved compared to stricter predicate's minimal amplitude) |
| SpO2 Function: | |
| Measurement Range | 0-100% (Same as predicate) |
| Accuracy (Adult/Pediatric) | ±2 % (70% to 100%), Undefined (0% to 69%) (Similar to predicate, with clarification for 0-69%) |
| Resolution | 1 % (Same as predicate) |
| Pulse Rate Measuring Range | 25 bpm to 300 bpm (Similar to predicate's 18-300 bpm) |
| Pulse Rate Accuracy | ±2bpm when MR: 25 bpm to 300bpm (Improved compared to predicate's varying ±3, ±6, ±9 bpm) |
| Pulse Rate Resolution | 1 bpm (Same as predicate) |
| Environmental Specifications (Operating): | |
| Temperature Range | 0°C to +40°C (Same as predicate) |
| Humidity Range | 15% to 95% (non-condensing) (Same as predicate) |
| Altitude Range | 86kPa to 106kPa (Similar to predicate's 70.0 to 106.0kPa) |
| Compliance Standards: | |
| Electrical Safety | Complies with IEC 60601-1:2005/A1: 2012 |
| EMC | Complies with IEC 60601-1-2:2007 |
| Alarms | Complies with IEC 60601-1-8: 2006 |
| ECG Performance | Complies with IEC 60601-2-27: 2011, ANSI/AAMI EC57: 2012 |
| Multi-parameter Patient Monitoring Equipment | Complies with IEC 60601-2-49: 2011 |
| Pulse Oximeter Equipment | Complies with ISO 80601-2-61: 2011 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-5-10 |
| Software | Verified and Validated per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Concern Level: "major") |
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.