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The Tempus 2000 Patient Monitor System is intended to be used when a medical situation rises at a location remote from readily available medical expertise. Situations demanding use af the Tempus 2000 Patient Monitor System can occur at remote land locations on private yachts while sailing at considerable distances from land, and during flight on commercial /private iets as well as in other situations.

The Tempus 2000 Patient Monitor is intended to be used by trained non-experts upon people rne rompac Lowell. It is designed with the most ease of use for the operator so that it can be prooming as alliably, with minimum training and with little or no support from medical staff. This allows the Tempus 2000 Patient Monitor to be used as either a stand-alone monitor or also connected to the Tempus Monitoring Station. In the latter mode, the Tempus 2000 Patient Monitor connects to a sister device, called the Tempus Monitoring Station, allowing the recorded data to be viewed, stored and manipulated by trained medical staff.

The Tempus Monitoring Station is a normal, commercial grade PC which is dedicated to running the software that enables it to communicate with the Tempus 2000 Patient Monitor. The Tempus Monitoring Station is installed at a Response Centre (typically an emergency room within a hospital) and is operated by experts from the hospital staff. The operator at the Response Centre is able to receive voice calls and data on the patient's condition for assessment and consequently advise on an appropriate course of action. Such action may include advice on treatments to stabilize the condition, or instructions to return to land or divert from the planned journey, if the patient is at sea or in the air.

The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present.

The device is intended to be applied to the patient by a trained operator who is not a medical rric device is intended to be applied to allow the operator to make any clinical decision for treatment or diagnosis. The device permits the operator to take measurements from a patient, troutinon. of aller transmission or transmit medical information to a Response Centre at the time of recording, where trained staff can make clinical assessments based on the information transmitted and advise the operator on the nature of the medical incident. A trained information transmitted annous 2000 Patient Monitor as a standalone diagnostic device.

The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The Tempus 2000 Patient Monitor is a portable, multi-parameter patient monitor. The unit is housed in a plastic enclosure and comprises a large colour screen, a rechargeable battery and a wrist-mounted keypad which incorporates a digital camera.

The device can measure a patient's ECG (Electro Cardio Graph) using a 12-lead harness, noninvasive blood pressure, temperature (infra-red tympanic), respiration rate, end-tidal exhaled CO2, pulse rate and Sp02 (blood oxygen saturation).

The device collects the patient's physiological data and displays the data in numeric and graphical form to the operator and, remotely, to a Response Centre.

The operator interfaces with the device via 8 control buttons (with an additional button on the thermometer, a battery power level button and an on/off button on the front panel) and by graphical help-screens that are displayed in a logical sequence for ease of use. The graphical holp or splayed for all operations including operating the main medical functions, no port one are acking the unit and clearing basic errors that can be expected when using the system e.g. blood pressure hose occlusions or telecoms connection errors.

The device is fitted with a colour, digital video-stills camera for transmitting images of the patient to the Response Centre.

The Tempus 2000 Patient Monitor is designed to connect only to a PC which is configured with the Tempus Monitoring Station software.

The provided text describes a 510(k) submission for a modification to an existing medical device, the Tempus 2000 Patient Monitor. The modification primarily concerns communication methods. As such, the submission focuses on demonstrating that the changes do not degrade the device's existing performance.

Here's an analysis of the provided information against your required points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new diagnostic or AI-driven device. Instead, the testing aimed to confirm that the existing performance and specifications were not negatively impacted by the modification.

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

The document does not detail specific "sample sizes" for a clinical "test set" in the context of typical diagnostic or AI performance evaluation. The testing performed was primarily bench testing to verify that the modifications did not degrade existing performance.

• No specific patient "test set" sample size is mentioned.
• No data provenance (country of origin, retrospective/prospective) for a test set is provided, as the testing described is not a clinical study involving patient data for diagnostic accuracy.

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

Not applicable. This was not a study requiring expert-established ground truth on patient data. The "ground truth" was based on existing design specifications, measured performance against known input signals, and compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is not mentioned as it's not relevant to the described modification which focuses on communication and integration, not diagnostic capability or human-AI interaction.

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

While the device itself is a "standalone monitor" in its intended use by non-experts, the "standalone" context you're likely referring to (e.g., an AI algorithm's performance in isolation) is not applicable here. The testing focused on the integrity of the device's measurement accuracy and communication functions, which implicitly involves the device operating independently in those respects.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on:

• Existing design specification criteria: The device was tested against its previously established performance metrics.
• International performance standards and guidelines: Compliance with standards like IEC60601-1 and IEC60601-1-2.
• Known input signals: Measurement accuracy would be verified using calibrated physiological simulators or known electrical signals.

8. The Sample Size for the Training Set

No training set is mentioned. This device is a traditional patient monitor, not an AI/machine learning model that requires training data.

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

Not applicable, as there was no training set.

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