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The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.

Manual Defibrillation: In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia. Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Cardioversion: The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.

External Pacing: The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology. As a standby when standstill or bradycardia might be expected. External pacing is indicated for adult and pediatric patients.

ECG Display: The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).

CPR Feedback: The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.

The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock. The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.

This is a 510(k) summary for the TEMPUS LS - MANUAL, a multi-function defibrillator. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and non-clinical performance testing. It does not contain information about a clinical study with acceptance criteria in the typical sense of metrics like sensitivity or specificity for an AI algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document describes "pre-established acceptance criteria" but does not explicitly list them or quantify performance metrics in a table. Instead, it states that various tests "met requirements" or "met the requirements of the standard," implying that the acceptance criteria were compliance with specific industry standards and successful operation in bench testing.

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

The document does not detail a "test set" in the context of an AI algorithm's performance. The closest analogous information is for the Human Factors validation testing:

• Sample size: 15 participants
• Data provenance: Not specified, but given the manufacturer is UK-based and the test was for usability, it's likely the participants were located in a similar context. It was a prospective study to evaluate usability.

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

This information is not provided as the document describes non-clinical testing and human factors usability, not a clinical study requiring expert-established ground truth for diagnostic accuracy.

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

This information is not provided as the document does not describe a process that would involve expert adjudication of a test set for diagnostic performance.

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 MRMC comparative effectiveness study was not done with human readers and AI assistance. This document describes a medical device (defibrillator) primarily relying on hardware and embedded software functionality, not an AI-powered diagnostic tool that assists human readers.

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

This concept is not directly applicable to the device described. The "algorithm" here refers to the device's operational functions (defibrillation waveform generation, pacing parameters, CPR metronome, etc.) rather than a diagnostic algorithm generating an output for review. Bench testing was performed for these functionalities, which could be considered "standalone" in the sense that the device's technical specifications were verified against standards.

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

For the non-clinical performance testing, the "ground truth" was the pre-established acceptance criteria derived from recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-4). For the human factors study, the ground truth was the successful and safe use of the device by participants, evaluated against predefined usability metrics.

8. The sample size for the training set

The document does not mention a "training set" as it is not for an AI/ML algorithm that undergoes a training phase with a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML 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 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.

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 and 12 Lead ECG recording, impedance pneumography, non-invasive 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 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, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, 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.q. 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 document is a 510(k) premarket notification for the Tempus Pro Patient Monitor with added accessories (ultrasound & video laryngoscope probe). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria for the performance of the device (Tempus Pro with new accessories) in detecting particular conditions or making diagnoses. Instead, the acceptance criteria are generally framed around meeting relevant standards and demonstrating equivalence to predicate devices.

Study Information & Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify a sample size for a test set in terms of patient data or images. The testing described is primarily bench testing and comparative testing to predicates at a system level, not a clinical study involving patients or diagnostic accuracy.
   • Data Provenance: Not applicable in the context of clinical data for performance evaluation. The device is manufactured by Remote Diagnostic Technologies Ltd. in the United Kingdom.

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

   • Not applicable. No clinical test set requiring expert-established ground truth is described. The tests are focused on technical performance, software compliance, and equivalence to existing devices, not diagnostic accuracy based on expert consensus.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical data interpretation or diagnostic assessment by experts requiring adjudication is described.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. The document does not describe an MRMC study. The focus is on the device's technical ability to display images from the accessories and its equivalence to predicate devices, not on how human readers perform with or without AI assistance using the device. The device itself is a monitor, not an AI diagnostic tool.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a patient monitor displaying images from accessories. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that would operate standalone or without human interpretation of the displayed image. The "algorithm" here would refer to the device's operating software and drivers for displaying the images.

6. The Type of Ground Truth Used:

   • For the bench testing of parameters, the ground truth would be based on engineering specifications, known input signals, and established standards (e.g., how accurately a known voltage signal is measured, or how faithfully a simulated ultrasound image is rendered).
   • For the software compliance, the ground truth is adherence to the requirements outlined in the FDA Guidance for Software and IEC 62304.
   • For comparative testing to predicates, the "ground truth" is the established performance and functionality of the cleared predicate devices.

7. The Sample Size for the Training Set:

   • Not applicable. This document describes a medical device, not a machine learning or AI model that requires a training set of data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As the device does not involve a machine learning model, there is no training set or associated ground truth establishment process for it.

In summary, this 510(k) focuses on demonstrating the technical and functional equivalence of adding new accessories to an existing cleared patient monitor, rather than presenting a clinical performance study with diagnostic accuracy metrics. The acceptance criteria and performance are reported in terms of compliance with regulatory standards, successful bench testing, and equivalence to predicate devices for displaying images and transmitting data.

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 and 12 Lead ECG recording with interpretation, impedance pneumography, non-invasive blood pressure (NIBP), endtidal CO2 (ETCO2), respiration rate, pulse oximetry (SpO2), contact temperature, invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), metheglobin (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, pediatrics 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, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, 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 GP$ receiver and voice via a wired or wireless headset.

Here's an analysis of the Tempus Pro (EF) medical device submission based on the provided document, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical testing to ensure the device meets safety and performance standards. It does not contain specific quantitative "acceptance criteria" and "reported performance" like sensitivity/specificity for a diagnostic AI model. Instead, the acceptance criteria are implicit: successful completion of tests according to relevant international standards and equivalence to predicate devices.

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

The document describes non-clinical engineering and bench testing, not a clinical study with a "test set" in the sense of a dataset for an AI algorithm. Therefore, no specific sample sizes for a test set are mentioned, nor is there data provenance in terms of country of origin or retrospective/prospective for a clinical dataset. The testing primarily involved the device itself and its components.

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

Since this is a submission for a vital signs monitor and not an AI-driven diagnostic device requiring expert interpretation of outputs, there were no experts used to establish ground truth for a test set in the typical sense. Expertise was likely involved in setting the testing standards and interpreting the results of the engineering tests (e.g., verifying compliance with IEC standards), but this is not specified as "ground truth establishment."

4. Adjudication Method for the Test Set

As there is no diagnostic "test set" with subjective interpretations, no adjudication method (like 2+1 or 3+1) was used or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or reported. The device is a vital signs monitor, and the submission focuses on verifying its technical performance and substantial equivalence to predicate devices, not on the improvement of human reader performance with AI assistance. The "AI" component mentioned is the "interpretation output" of the mymisys32.dll for 12-Lead ECG, but this is presented as a pre-existing component from a cleared device (QRS Diagnostic CardioView K083749) that is now being displayed, rather than a new AI requiring an MRMC study for effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The 12-Lead ECG interpretation (part of the mymisys32.dll) is an algorithmic function. The submission indicates that "the interpretation output of the ■ mymisys32.dll, which is already an integral part of the cleared Tempus Pro, but the interpretation output is not currently displayed to the user." It further states that this dll is part of a previously cleared software package (QRS Diagnostic CardioView K083749).

This means the algorithm for ECG interpretation has been evaluated in standalone fashion as part of its original clearance (K083749). For this specific submission, the focus is on the safety and effectiveness of displaying this pre-existing interpretation, rather than re-evaluating the algorithm itself. Yes, a standalone evaluation of this ECG interpretation algorithm would have been done for its original clearance, and the current submission relies on that prior clearance.

7. The Type of Ground Truth Used

For the engineering and bench testing, the "ground truth" was established by objective technical specifications and compliance with international standards (e.g., IEC60601-1, IEC 9919, RTCA DO-160). For the ECG interpretation component (mymisys32.dll), its original clearance (K083749) would have relied on expert consensus or clinically validated ECG databases to establish ground truth for its interpretive accuracy, though this is not detailed in the provided document.

8. The Sample Size for the Training Set

This document does not describe the development or training of a de novo AI algorithm. The components added (Masimo SET Rainbow module, Medlab IBP module, QRS Diagnostic CardioView dll) are all from established, previously cleared predicate devices. Therefore, no sample size for a training set for the Tempus Pro (EF) itself is mentioned. Any training data for the individual components (like the ECG interpretation algorithm) would have been part of their original development and clearance, which is not detailed here.

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

Given that no de novo AI algorithm training is described for the Tempus Pro (EF) in this submission, the establishment of ground truth for a training set is not applicable to this document. For the pre-existing components (e.g., the ECG interpretation algorithm), ground truth for their training would have been established during their original development, likely through expert cardiologist consensus on annotated ECG waveforms or through comparison with established diagnostic methods.

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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 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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Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations.

Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident.

Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required.

Tempus IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).

Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The TempusIC™ is an advanced multi-parameter vital signs monitor designed for use in remote locations by trained non-expert users. It provides a wide range of features in a highly robust package, including integrated voice link and video camera.

The device remains unchanged from its previous/existing clearance with the exception that the device is now capable of receiving (wirelessly over a Bluetooth™ link) both tympanic temperature readings from a tympanic thermometer (cleared under K101264) and blood glucose data from the Entra Health Systems MyGlucoHealth glucometer (cleared under K081703),

Voice and data connections are made automatically via existing satellite or terrestrial communications systems.

The TempusIC™ is used in conjunction with TempusNET™ software, which provides a system for receiving real-time voice and vital signs data. The system enables users to receive voice, vital signs data, and still video pictures from TempusICTM devices located anywhere in the world.

The TempusNET™ system can be used by commercial response centre service providers or by individuals or organisations wishing to provide their own internal service.

It also provides a synchronised user interface, and remote control of the TempusIC™.

TempusNET™ also supports a full patient records database.

The provided 510(k) summary for the RDT Tempus IC Patient Monitor indicates that the device's clearance is based on its substantial equivalence to a legally marketed predicate device (itself, prior to the addition of wireless peripherals). The study details focus on the newly added functionalities (wireless temperature and blood glucose measurement) and their reliable and accurate transmission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets for performance metrics (e.g., accuracy, precision) for each vital sign parameter. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to predicate devices and the reliability and accuracy of data transmission for the new wireless peripherals.

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

The document primarily refers to "testing" without providing specific sample sizes for individuals or data points for the comparative or bench tests.

• Sample Size: Not explicitly stated. The description mentions "comparative testing," "bench testing," and "wireless range/co-existence testing," but details on the number of measurements, subjects, or data points are absent.
• Data Provenance: Not explicitly stated. The tests are described as being performed to "benchmark" the device and confirm reliable/accurate data transmission. It's likely these were internal laboratory or engineering tests, but no geographic or retrospective/prospective details are given.

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

This information is not provided in the document. The testing described primarily focuses on the technical performance of the wireless data transmission features of the new peripherals, rather than diagnostic accuracy established by medical experts on a "test set" of patients.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the testing described (benchmarking data transmission, wireless performance), an adjudication method as typically applied to clinical diagnostic studies is not relevant or described.

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

No, an MRMC comparative effectiveness study is not described. The document focuses on the device's performance and its equivalence to predicates, not on how human readers' effectiveness might improve with or without AI assistance. This device is a vital signs monitor, not an AI-powered diagnostic system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document describes testing of the device's components, particularly the wireless glucometer and its data transmission. This would be analogous to a standalone performance evaluation of those specific functionalities (e.g., how accurately and reliably the glucometer transmits data). However, it's not an "algorithm-only" study in the context of an AI-powered diagnostic algorithm. It's a hardware/software system performance evaluation.

The "bench testing" and "wireless range/co-existence testing" for the glucometer can be considered standalone performance evaluations of those specific functionalities.

7. Type of Ground Truth Used:

For the glucometer functionality, the ground truth would likely be established by a reference method for blood glucose measurement to determine the "accuracy" of the data received. For wireless reliability, the "ground truth" is simply whether the data was successfully transmitted and received without error, and if it matched the source data.

• For Glucometer Accuracy (implied): A reference blood glucose measurement. The document states "benchmarking to confirm the MyGlucoHealth data was received reliably and accurately," implying a comparison to a known standard.
• For Wireless Reliability: Successful transmission and reception of data without corruption, verified against the original transmitted data.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The Tempus IC Patient Monitor is a vital signs monitoring device, not a machine learning or AI system that requires a "training set." Its functionality relies on established physiological measurement technologies and data transmission protocols.

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

This information is not applicable. As stated above, there is no "training set" for this device in the context of machine learning. The device's operation is based on physical sensors and software logic, not learned patterns from a training dataset.

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The Tempus IC Professional 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 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal CO2 (ETCO2), pulse oximetry (SpO2) and tympanic temperature.

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 ECG Harness.of the Tempus IC Professional is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The Tempus IC Professional is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals e.g. nurse. EMT, paramedic, physician, army corpsman etc. It provides 3 lead ECG monitoring, 12 lead ECG recording, pulse Oximetry, non-invasive blood pressure, sidestream Capnometry, a tympanic thermometer and user configurable alarms.

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

The device is intended to be used primarily as a standalone monitor for traditional monitoring applications. It is expected that its real-time telemedicine capabilities will be used in a minority of applications. When its telemedicine features are used it is intended that this will be for the purpose of obtaining support in the diagnosis and treatment decisions for the patient e.g. where the patient is in a remote country and the user's organisation needs to make an extraction or repatriation decision.

It is expected that the ability to transmit data in real-time will be performed in remote locations typically using satellite or terrestrial communications systems.

The provided text describes the Tempus IC Professional Patient Monitor, a multi-parameter vital signs monitor. However, it does not include detailed acceptance criteria tables with reported device performance metrics in the format requested. The document primarily focuses on regulatory approval (510(k)) and describes the device, its intended use, predicate devices, and various types of testing performed to demonstrate conformity to standards and equivalence to predicates.

Therefore, I cannot generate the requested table of acceptance criteria and reported performance directly from the provided text. The document states that "Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates. This comprised benchmarking against the Propaq for ECG and alarm performance and against the TH809 for temperature measurement performance." but does not provide specific numerical acceptance criteria or performance results from these comparative tests.

Similarly, much of the requested information regarding sample sizes, data provenance, expert ground truth, adjudication methods, and specific study designs (MRMC or standalone) are not available in the provided text. The document refers to general testing categories like AAMI EC13 for ECG, IEC standards for alarms and biocompatibility, and software validation but does not elaborate on the specific details of these studies in the context of the device's performance against defined acceptance criteria.

Based on the provided text, here is what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was performed to "demonstrate that the performance of the device is equivalent to the predicates" and to standards like AAMI EC13, IEC60601-1-8, etc., but it does not provide specific numerical acceptance criteria or the reported performance data for these parameters.

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

Not available in the provided text. The document mentions "comparative testing" and "bench testing" but does not specify the sample sizes or the provenance (country of origin, retrospective/prospective) of the data used in these tests.

3. Number of Experts Used to Establish the Ground Truth and Their Qualifications

Not available in the provided text. Ground truth methods and expert qualifications are not described for any testing.

4. Adjudication Method for the Test Set

Not available in the provided text. Adjudication methods (e.g., 2+1, 3+1, none) are not mentioned.

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

Not available in the provided text. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a vital signs monitor and does not appear to involve AI assistance for human readers in diagnostic interpretation.

6. Standalone Performance Study

The document indicates that the device is primarily intended to be used as a "standalone monitor for traditional monitoring applications" and that "bench testing" was performed to confirm reliable and accurate data transmission. However, it does not detail a specific "standalone (i.e. algorithm only without human-in-the loop performance)" study with defined metrics. The closest mention is: "The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus IC Professional is effectively identical to the devices that incorporate the same OEM technology." This suggests reliance on the performance characteristics of the OEM components rather than a novel algorithm's standalone performance.

7. Type of Ground Truth Used

Not explicitly stated in the provided text. Given the nature of the device (vital signs monitor benchmarking against predicate devices and industry standards), the ground truth for performance testing would likely be based on:

• Reference measurements from calibrated equipment: For parameters like ECG, NIBP, SpO2, ETCO2, and temperature, the accuracy would be compared against highly accurate reference devices or simulators during bench testing.
• Predicate device performance: "Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates." This implies the predicate devices' established performance serves as a comparative ground truth.

8. Sample Size for the Training Set

Not applicable/Not available in the provided text. The Tempus IC Professional is a vital signs monitor that utilizes OEM technology. The document does not describe any machine learning or AI algorithms that would require a "training set" in the conventional sense for a diagnostic device.

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

Not applicable/Not available in the provided text. As there is no mention of a training set or machine learning algorithms, this information is not provided.

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Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations.

Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident.

Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required.

Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The TempusIC™ is an advanced multi-parameter vital signs monitor designed for use in remote locations by trained non-expert users. It provides a wide range of features in a highly robust package, including integrated voice link and video camera.

Voice and data connections are made automatically via existing satellite or terrestrial communications systems.

The TempusIC™ is used in conjunction with TempusNET™ software, which provides a system for receiving real-time voice and vital signs data. The system enables users to receive voice, vital signs data, and still video pictures from TempusICTM devices located anywhere in the world.

The TempusNET™ system can be used by commercial response centre service providers or by individuals or organisations wishing to provide their own internal service.

It also provides a synchronised user interface, and remote control of the TempusIC™

TempusNET™ also supports a full patient records database.

The provided text describes the TempusIC™ Patient Monitor, but it explicitly states that "Clinical tests have not been performed" to prove the efficacy of the measurement techniques. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on the following:

• Substantial Equivalence: The device is claimed to be substantially equivalent to previously cleared predicate devices (Tempus 2000 Patient Monitor, K033410 & K0443 (note: K0443 is likely a typo for K04436 as per the text)).
• OEM Modules: All medical modules and sensors used in the TempusIC™ have prior 510(k) clearance and are used as intended by their manufacturers.
• Bench and Performance Testing: Functions and features additional to the measurement of medical parameters have been tested by bench and performance testing.
• Desat Study: A "conventional desat study" was carried out to verify that the performance of the combined PCB and probe were within specification. However, the details of this study, its acceptance criteria, or its results are not provided.
• User Evaluations: User evaluations were conducted to confirm ease-of-use, not clinical performance.
• Conformity to Essential Principles: Evidence of conformity to GHTF guidance (GHTF/SG1/N14R9:2005 and SG1/N011: 2008) is cited, including performance testing, software validation, electrical safety, electromagnetic compatibility, and risk analysis. Again, specific performance acceptance criteria and results are not detailed.

Given this, I cannot provide a table of acceptance criteria and reported device performance based on clinical studies, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies for clinical performance, as these were explicitly not performed.

However, based on the information provided, here's what can be inferred about the type of justification used for device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
As clinical tests for efficacy were not performed, there is no "test set" in the sense of patient data for clinical performance evaluation. The "desat study" mentioned is vague on sample size and provenance. User evaluations involved "representative groups," but the size is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as clinical tests were not performed. For user evaluations, "professional, non-professional but trained, and untrained users" were involved, but their number and specific qualifications (beyond "professional" or "trained") are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as clinical tests were not performed.

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, an MRMC study was not done. The device description does not involve AI or reader interpretation in that context. The system involves remote medical staff interpreting data and advising operators, but this is not an MRMC study on device performance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
The device itself is a "standalone monitor" in its basic use, but its full intended use involves human interpretation of its transmitted data by medical professionals. Since no clinical performance study was done for the device as a whole, it's not possible to describe a standalone algorithm-only performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical performance, as clinical tests were not performed.
For the "desat study," the "specification" serves as a form of ground truth, but its origin and specific values are not presented.
For user evaluations, the "ease-of-use design objective" was the ground truth, assessed by user feedback.

8. The sample size for the training set:
Not applicable, as no algorithm requiring a training set for clinical performance is detailed. Data collected by the device would be for patient monitoring, not for training a predictive algorithm within the device for clinical decision-making.

9. How the ground truth for the training set was established:
Not applicable, as no training set is described.

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