(77 days)
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, noninvasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
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 Tempus Pro is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximely (SpO2), contact temperature and invasive pressure ..
In addition, it provides the ability to transmit all vital signs data via wired Ethernet or wireless WiFi connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also capture and transmit other data including still or moving pictures via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.
The provided text describes the Tempus Pro™ Patient Monitor, a multi-parameter vital signs monitor. However, the document primarily focuses on demonstrating its substantial equivalence to predicate devices through various safety and performance tests against established standards. It does not contain specific acceptance criteria, study designs, or reported device performance metrics in the format requested.
The document states: "The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus Pro 14 is effectively identical to the devices that incorporate the same OEM technology." This suggests that the performance is expected to align with the OEM components, but explicit criteria and comparative performance data are not detailed.
Therefore, I cannot populate the table or answer all the questions as the specific information is not available in the provided text.
Here's a summary of what can be extracted and identified as missing or not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy) | Reported Device Performance |
|---|---|
| Not explicitly stated for individual parameters. The document implies performance is equivalent to predicate devices and meets relevant IEC/AAMI standards for specific functions. | Not explicitly stated for individual parameters. The document generally states that "all parameters of the device have been tested to confirm they operate to specification across their stated performance range and across their stated temperature range." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the provided text. The document lists various types of testing performed (e.g., IEC60601-1, AAMI EC11 & EC13, comparative testing to predicates, bench testing for data transmission). These are generally engineering/bench tests rather than clinical studies with patient data.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The testing described is primarily technical and regulatory compliance testing against recognized standards, not expert-adjudicated ground truth for a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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. This device is a patient monitor, not an AI-powered diagnostic system requiring MRMC studies for human reader improvement. The document mentions "telemedicine capabilities" for "obtaining support in the diagnosis and treatment decisions," but this refers to transmitting data to human experts, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware patient monitor. Its primary function is to acquire and display vital signs. While it transmits data, it's not a standalone algorithm in the AI sense. The "bench testing" to confirm data transmission reliability and accuracy could be considered a form of standalone performance evaluation for that specific function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For regulatory and performance testing (e.g., ECG monitoring, NIBP, SpO2), the "ground truth" would be established by reference instruments or simulated physiological signals that meet the accuracy requirements of the relevant industry standards (e.g., AAMI, IEC). This is typically referred to as "reference standard" data.
8. The sample size for the training set:
- Not applicable. The device is not an AI/machine learning model that typically requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document details the testing performed to demonstrate the safety and effectiveness of a medical device (Tempus Pro™ Patient Monitor) for 510(k) clearance, primarily by showing conformity to international standards and substantial equivalence to predicate devices. It does not include the type of detailed performance study results, acceptance criteria, or ground truth establishment methods typically associated with AI/diagnostic device submissions.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).