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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 & 5 Lead ECG monitoring; 12 Lead ECG recording with interpretation; real-time arrhythmia detection / alarming; OT measurements / alarming; impedance pneumog; impedance pneumography; noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (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 is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG monitoring, 12 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment measurement & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpCO, PVI and PI), non-invasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes can be attached to the device.

In addition, it provides the ability to transmit all vital signs data via wired or wireless 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 send pictures or video via an integrated camera, geographic position by an integrated GPS receiver, and voice via a wired or wireless headset.

The Tempus Pro was originally cleared under K130773 and was subsequently amended with new features under K133988 (extended SpO2, invasive pressure and 12 Lead ECG Interpretation), K134014 (ultrasound and laryngoscopy) and K133973 (ECG arrhythmia alarming). This 510(k) is to consolidate the Indications for Use statements that are different across the four 510(k)s.

Based on the provided document, the device in question is the Tempus Pro Patient Monitor, and this 510(k) submission (K170567) is primarily for consolidating existing Indications for Use statements from previous 510(k) clearances (K130773, K133988, K134014, and K133973). The document explicitly states that no new technological changes were made and therefore, no new performance testing or clinical studies were necessary to demonstrate substantial equivalence for this specific submission.

Therefore, the information required to populate the fields regarding acceptance criteria and performance studies for a new device or new feature is not present in this document. The document primarily focuses on regulatory consolidation rather than detailing new performance data.

Here's how to interpret the request based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. This submission is for consolidating existing indications for use. No new performance data or acceptance criteria are discussed as there are no new technological changes. The previous clearances (K130773, K133988, K134014, K133973) would have contained such information for the specific features cleared at those times (e.g., 12 Lead ECG Interpretation, extended SpO2, invasive pressure, ultrasound, laryngoscopy, ECG arrhythmia alarming).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No new test sets were performed for this consolidation. The document states: "Non-clinical evidence was not necessary to demonstrate substantial equivalence." and "Clinical evidence was not necessary to demonstrate substantial equivalence."

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)

• Not applicable / Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided.

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

• Not applicable / Not provided. The Tempus Pro is a patient monitor, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable / Not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided. There is no mention of a training set as this is about a patient monitor, not an AI/ML model being trained.

9. How the ground truth for the training set was established

• Not applicable / Not provided.

In summary: The provided document is a 510(k) clearance letter and an Indications for Use statement for the Tempus Pro Patient Monitor. This specific submission (K170567) serves to consolidate previously cleared Indications for Use statements. It explicitly states that no new non-clinical or clinical evidence was required to demonstrate substantial equivalence because there were no technological differences between the predicate devices and the subject device (which is essentially the same device with a consolidated IFU). Therefore, detailed performance data, acceptance criteria, study sizes, or ground truth establishment methods for this submission are not available in the given text. Such details would have been part of the previous 510(k) submissions (K130773, K133988, K134014, K133973) when the individual features were originally cleared.

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