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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-, 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:

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."

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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: QT measurement / alarming and ST measurements / 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; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) The monitor is intended to be used as a stand-alone monitor or as a telemedicine system measurements. (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 monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI and Pl), non-invasive 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 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.

This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer, which enables the user of a Tempus Pro to print medical records on-demand. Additionally, compatible external devices may also print medical records on the Tempus Pro's optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).

The provided text describes a 510(k) submission for the Tempus Pro Patient Monitor. However, this submission (K173768) is specifically for a modification to the existing Tempus Pro device, which is the addition of an optional thermal printer. The document explicitly states: "This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer..." and "No changes have been made to the device's indications for use, intended use, or fundamental scientific technology as a result of the modification that has prompted this submission."

Therefore, the provided text does not contain the acceptance criteria or study details for the core functionalities of the Tempus Pro Patient Monitor (e.g., ECG monitoring, arrhythmia detection, NIBP, SpO2 measurements). It only discusses the non-clinical evidence related to the addition of the thermal printer.

Here's a breakdown of what can be extracted from the provided text regarding this specific modification:

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

The document states: "Non-clinical testing has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate." However, it does not provide specific acceptance criteria (e.g., print speed, resolution, accuracy of printed data) or performance data (e.g., results of specific tests for thermal printer quality).

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified for the thermal printer.
• Data Provenance: The testing was "non-clinical testing," but further details (e.g., country of origin, retrospective/prospective) are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. This was non-clinical testing related to a printer, not diagnostic accuracy requiring expert interpretation of medical images or signals.

4. Adjudication method for the test set:

• Not applicable/Not specified. This was non-clinical testing related to a printer, not diagnostic accuracy 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 study was not mentioned. The device modification is a thermal printer, 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 specified. This is a hardware modification (thermal printer), not an algorithm.

7. The type of ground truth used:

• Not applicable/Not specified. For the thermal printer, the "ground truth" would likely relate to the ability of the printer to accurately reproduce data the device generates, rather than a medical ground truth (like pathology). The document only mentions "safety and efficacy."

8. The sample size for the training set:

• Not applicable/Not specified, as this submission is for a hardware modification (thermal printer) and not an algorithmic device requiring a training set.

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

• Not applicable, as there is no training set mentioned for this modification.

In summary: The provided document is a 510(k) summary for an administrative change and a modification to the Tempus Pro Patient Monitor (addition of a thermal printer). It states that non-clinical testing was performed for this modification to ensure substantial equivalence regarding safety and efficacy, but it does not provide specific acceptance criteria, performance data, sample sizes, expert details, or ground truth methodologies for the thermal printer functionality, nor for the original device's performance. The original Tempus Pro Patient Monitor (K170567) would have contained this information for its core functionalities.

Ask a specific question about this device

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.

Ask a specific question about this device

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:

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.

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