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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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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; real-time arrhythmia detection / alarming; QT measurement / alarming and ST measurements / alarming: 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 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 measurement / alarming and ST measurements / alarming pulse oximetry, non-invasive blood pressure, sidestream capnometry, 2 channels of contact temperature, impedance respiration, up to 4 channels of invasive pressure and user configurable alarms.

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 provided text describes a 510(k) submission for the Tempus Pro Patient Monitor with Enhanced Features, specifically the addition of arrhythmia detection/alarming, QT measurement/alarming, and ST measurements/alarming.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the Arrhythmia detection, ST elevation, and QT interval measurements were evaluated in accordance with FDA guidance on arrhythmia detection and alarm, using the FDA recognized consensus standard EC57 (FDA Rec No: 3-118). However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for these features. It only states: "A summary report demonstrating compliance with the guidance and associated standard is presented as part of this 510(k) submission." and "In each case the results of this testing confirmed that acceptance criteria defined by the relevant standard, or other appropriate reference document had been met."

Without access to the "summary report" or the full 510(k) submission, we cannot extract specific numerical acceptance criteria or reported device performance for the new features. The table below reflects the information that is available.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that the evaluation was performed in accordance with "FDA guidance on arrhythmia detection and alarm" and "the FDA recognized consensus standard EC57 (FDA Rec No: 3-118), which defines methods of presenting results when testing against specified ECG databases."

However, the provided text does not specify the sample size (e.g., number of patients, number of ECGs) used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of the ECG databases used. EC57 typically refers to standard databases like MIT-BIH Arrhythmia Database, but this is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for the test set. For standard ECG databases (like those referenced by EC57), ground truth is typically established by multiple expert cardiologists.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set. If standard ECG databases were used, the ground truth annotations would have been established prior to the device under test being evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs without AI assistance. The focus of this 510(k) appears to be on the device's standalone performance in arrhythmia detection and measurement against established standards.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone study was done. The document states that "Arrhythmia detection and alarms, ST elevation and QT interval measurements... were evaluated in accordance with FDA guidance on arrhythmia detection and alarm... This guidance calls for use of the FDA recognized consensus standard EC57 (FDA Rec No: 3-118), which defines methods of presenting results when testing against specified ECG databases." This indicates the algorithm's performance was evaluated independently against pre-annotated databases, which is a standalone assessment.

7. Type of Ground Truth Used

The ground truth used would be expert consensus annotations as provided in the "specified ECG databases" referenced by the EC57 standard. These databases contain ECG recordings with validated annotations of arrhythmias and other cardiac events, established by a panel of cardiologists.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the algorithms. It is possible the algorithms were pre-trained and integrated, or that general ECG databases were used for training, but this is not detailed.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. If standard ECG databases were used for training, the ground truth would have been established by expert consensus annotations within those databases.

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