(84 days)
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxyhaemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts/ Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their indications for use.
The Tempus Pro Patient Monitor is a multi-parameter vital signs monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3-Lead and 5-Lead ECG monitoring, 12-Lead ECG recording, real-time arrhythmia detection and alarming, QT interval measurement and alarming, ST segment measurement and alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI, and PD, noninvasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes may also be connected to the device. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a telemedicine software system (called i2i) expected to be based in a facility far from the user e.g. a response center facility. As an alternative to i2i response center software, Tempus Pro Monitor also uses IntelliSpace Corsium, which is a web-based software platform for near real-time patient data transfer and two- way communication between healthcare professional. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic positions by an integrated GPS receiver, and voice via a wired or wireless headset.
Additionally, Tempus Pro has an optional thermal printer, which enables the user to print medical records on-demand and allows other compatible external devices to print medical records as well using the optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
The Tempus Pro is provided to the user non-sterile. No accessories manufactured by RDT for use with Tempus Pro are provided sterile. The Tempus Pro does not come into direct or indirect contact with the patient. The Tempus Pro is compatible with 3rd party manufacturer accessories, for which patient contact and sterility requirements are determined by the 3rd party manufacturer.
The provided text describes the acceptance criteria and a study to prove the device meets these criteria for the Tempus Pro Patient Monitor with the addition of the Glasgow Algorithm for 12-lead ECG interpretation.
Here's a breakdown of the requested information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All interpretations output from the Glasgow library run on Tempus Pro shall match the known reference interpretations (for Glasgow algorithm test vectors). | PASS: A total of 612 known vectors were used for comparison with interpretations from Tempus Pro. The results obtained were consistent with the results expected by Glasgow University. |
| The interpretation statement shall be printed in bulleted format without any heading and shall be identical between the Tempus display, the thermal printer output, PDF report, Intellispace Corsium review display, and Intellispace Corsium PDF. | PASS: Glasgow library was tested for reliability and consistency. Interpretation results were found to be identical on Tempus Pro, Corsium, thermal printer output, PDF reports, and Corsium PDF reports. |
| All software features tested shall output the expected result per the protocol and associated software specification (for Tempus Pro software changes testing). | PASS: All software features tested performed as specified in the protocol and associated SW specification document. |
| Outputs shall meet the acceptance criteria defined in the Integration Acceptance Test Protocol (IATP) protocol. | PASS: All outputs met the acceptance criteria defined in the IATP protocol. |
| Outputs of software and unit test shall meet the criteria defined in the relevant software specifications. | PASS: All system and unit testing met the criteria per the relevant software specifications. |
| Compliance with IEC 60601-2-25: 2011, Medical Electrical Equipment Part 2-25: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographs (Clause 201.12.1.101). | Test results confirmed that the acceptance criteria defined by IEC 60601-2-25:2011 was met. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size for testing the Glasgow Algorithm: 612 known test vectors.
- Data Provenance: The test vectors were "provided by Glasgow University". The document does not specify the country of origin of the data within these test vectors or whether they were retrospectively or prospectively collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth for the 612 test vectors provided by Glasgow University. It simply refers to "known reference interpretations."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for the test set. The validation relies on comparing the device's output to "known reference interpretations."
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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical testing was performed."
- This study focuses on the standalone performance and integration of the Glasgow Algorithm, which is an "optional off-the-shelf ECG interpretation algorithm" for the device, rather than its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the Glasgow Algorithm was conducted. The core of the software verification and validation section details how the Glasgow Algorithm's interpretations (when run on Tempus Pro) were compared against "known reference interpretations" using 612 test vectors.
- Additionally, the consistency of the algorithm's output across various display and reporting formats (Tempus Pro display, thermal printer, PDF reports, Intellispace Corsium) was verified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the Glasgow Algorithm validation consists of "known reference interpretations" provided by Glasgow University. While the underlying method for establishing these reference interpretations is not detailed, it implies a pre-established clinical gold standard for the specific ECG waveforms in the test vectors.
8. The sample size for the training set:
The document does not provide the sample size for the training set of the Glasgow Algorithm. It states that "Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm," but no training set size is mentioned.
9. How the ground truth for the training set was established:
The document does not describe how the ground truth for the training set of the Glasgow Algorithm was established. It only broadly states "Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm."
§ 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.