(127 days)
The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital in the mital in the mater vital care facilities, the home, workplace for monitoning of addits (11) facilities, the home, workplace and alternate care settings.
The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt.
The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion temperature, body orientation and motion.
The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitor, to provide physiology research and performance measuroment purpos research and performance measurement purposes.
The Equivital™ Vital Signs Physiological Monitor comprises two components:
i) A chest belt containing skin electrodes and an expansion sensor
ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device.
The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate.
The sensor also provides the following information:
- ECG and Respiration physiological waveforms .
- An indication of the user's activity level derived from a movement detection sensor .
- Body orientation and indications for change in orientation .
- Skin surface temperature .
- Alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function
- . Indications and alerts if physiology exceeds predefined boundaries
- Alternate secondary skin temperature measurement using infrared thermometer .
The device offers two variants for the wireless interface: a low power radio interface and a general purpose interface using Bluetooth™ technology.
The device offers two battery power options for the user, rechargeable or primary disposable cells.
The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.
This document describes the Equivital™ Vital Signs Physiological Monitor EQ02, but it does not contain a detailed study demonstrating its performance against specific acceptance criteria for each measured parameter.
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (Equivital EQ01) and compliance with relevant safety and electromagnetic compatibility standards.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This table cannot be fully populated as specific performance acceptance criteria (e.g., accuracy ranges for heart rate, respiration rate, temperature) and the numerical results of studies proving these criteria were met are not explicitly provided in the given text.
The document states that "Performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated as recommended by available guidance from the agency." This implies that performance was verified against the requirements of these standards, but the specific numerical acceptance criteria and the device's measured performance against them are not detailed.
| Parameter | Acceptance Criteria (from Standards, e.g., ANSI/AAMI EC13) | Reported Device Performance (numerical results of testing) |
|---|---|---|
| ECG Heart Rate | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" against ANSI/AAMI EC13 |
| Respiration Rate | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" |
| Skin Temperature | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" against ASTM E1965 98 (2009) |
| Activity Level | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" |
| Body Orientation | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" |
| Physiological Alerts | Not explicitly stated in document | "successfully demonstrated as recommended by available guidance from the agency" against ANSI/AAMI EC13 |
| Safety | EN60601-1 | "successfully demonstrated" |
| EMC | IEC60601-1-2 | "successfully demonstrated" |
| Biocompatibility | ISO 10993-1 | "successfully demonstrated" |
| Software | EN60601-1-4 | "meets the requirements" |
| Environmental | IP67 | "successfully demonstrated" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "Performance measurement and review" and "testing undertaken" but does not detail the methodology, sample sizes, or data provenance for these tests.
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)
This information is not provided in the document. The document describes a medical device for physiological monitoring, not a diagnostic imaging or AI device requiring expert ground truth for image interpretation. The "ground truth" for vital signs monitoring would typically come from comparison to a highly accurate reference device or direct physiological measurements, not expert consensus in the same way an AI diagnostic model would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations (e.g., radiology studies). For a vital signs monitor, the comparison would be against a reference standard or objective measurements, not subjective human interpretations requiring adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device. This is a vital signs monitor, not an AI-powered diagnostic tool, so such a study would not be applicable in this context. The device's function is to collect and transmit physiological data, not to assist human readers in interpreting complex cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" physiological monitor in the sense that it collects and processes data to derive heart rate, respiration rate, and other parameters directly from sensor inputs. The performance claimed (e.g., accurate heart rate calculation) is inherent to its algorithms. However, the document does not report a specific "standalone" performance study in the context of an AI algorithm being evaluated against human performance or ground truth. It refers to performance measurement against standards, which implies the device's accuracy in measuring various parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific "ground truth" methods used for the performance evaluations. However, based on the nature of medical device testing for vital signs monitors, the ground truth would typically be established by:
- Comparison to a gold-standard reference device: For parameters like heart rate, respiration rate, and temperature, laboratories use highly accurate and calibrated reference instruments to provide the "true" value against which the device under test is compared.
- Direct physiological measurements: In some cases, direct measurements (e.g., manual respiration counts, core body temperature probes) might be used as a reference.
It would not typically involve expert consensus, pathology, or outcomes data for the primary performance assessment of vital sign accuracy.
8. The sample size for the training set
This information is not applicable and not provided. The Equivital™ Vital Signs Physiological Monitor EQ02 is described as a telemetry device and monitor, not an AI/machine learning model that undergoes "training" in the conventional sense with a distinct training set. Its functionality is based on established signal processing and sensor technologies, not adaptive learning from a large dataset.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As stated above, the device does not use a "training set" in the context of machine learning. Its algorithms are likely based on fixed rules and signal processing techniques designed and validated through engineering principles.
§ 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.