(89 days)
The Tempus IC2 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. The Tempus IC2 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.
The Tempus IC2 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 IC2 measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETC02, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).
The Tempus IC2 is suitable for use on adults or children (over 10 years old and over 20kg in weight).
The Tempus IC2 device is a portable vital signs monitor that can measure 12 Lead ECG, non-invasive blood pressure. SpO2 and pulse rate. ETCO2 and respiration rate, temperature (via an unmodified thirdparty Bluetooth enabled tympanic thermometer) and blood glucose (via an unmodified third-party Bluetooth enabled glucometer). It also provides an integral camera, built-in third-party Bluetooth headset, touchscreen and membrane button controls, user removable lithium-ion battery and Ethernet, Wi-Fi and cellular phone communications. These are all the same features as provided by the Tempus IC.
The Tempus IC2 is intended primarily to be used as a telemedicine device for trained, non-healthcare practitioners in remote locations e.q. cabin crew on aircraft. It is designed to be and to transmit all data displayed to a healthcare practitioner in a different location. The healthcare professional receives the data on a PC installed with a programme called i2i. The device also transmits still or lowrate moving images (from the device to the i2i software) and also transmits voice communications through the use of an off-the-shelf Bluetooth headset which is connected to the Tempus IC2. These descriptions are all the same as the Tempus IC.
The Tempus IC2 is provided in a bag which stores the device and the accessories and consumables needed to operate the device. This is the same as the Tempus IC which is also provided with a bag.
The document does not contain specific acceptance criteria, reported device performance metrics (such as sensitivity, specificity, accuracy, or AUC), or detailed study results for a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
However, it does provide general information about non-clinical testing performed to establish substantial equivalence to predicate devices. Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for the device's diagnostic capabilities. Instead, it states that "the results of this testing confirmed that acceptance criteria defined by the relevant standard, or other appropriate reference document had been met." The comparisons table on page 4 details specifications for several vital sign measurements (SpO2, Pulse Rate, Respiration Rate, ETCO2, Temperature) and indicates that the technology used in Tempus IC2 is "equivalent to that used in the Tempus IC" or has "generally similar specification."
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SpO2:
- Tempus IC2 Range: 1-100%
- Tempus IC2 Accuracy (adults/child): no motion or low perfusion +/- 3 digits 70-100%
- Tempus IC Range: 50% - 100 %
- Tempus IC Accuracy: ±2 % at 70 % - 100 %
- Comparison: Both use previously cleared OEM technology; Tempus IC2 technology is equivalent.
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Pulse Rate:
- Tempus IC2 Range: 25 - 239 BPM
- Tempus IC2 Accuracy (all ages): no motion ≤3 digits, motion ≤5 digits
- Tempus IC Range: 25 - 300 BPM
- Tempus IC Accuracy: ±1bpm
- Comparison: Technology used in Tempus IC2 remains substantially equivalent.
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Respiration Rate (Capnometer):
- Tempus IC2 Range: 0 - 149 BPM
- Tempus IC2 Accuracy: 0-70 BPM ±1 BPM, 71-121 BPM ±2 BPM, 122-149 BPM ±3 BPM
- Tempus IC Range: 2-150 BPM
- Tempus IC Accuracy: ± 1BPM
- Comparison: Both enable monitoring via capnometry with similar specifications.
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Sidestream ETCO2:
- Tempus IC2 Range: 0 - 150 mmHg
- Tempus IC2 Accuracy: 0-38 mmHg ±2 mmHg, 39-150 mmHg (accuracy not fully specified in snippet)
- Tempus IC Range: 0 - 150 mmHg
- Tempus IC Accuracy: ±2 % - ±10 %
- Comparison: Both utilize sidestream technology with similar specifications.
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Tympanic Temperature:
- Tempus IC2 Range: 32°C - 43°C
- Tempus IC2 Accuracy: ±0.2°C (36-39°C) ±0.4°C (39°C)
- Tempus IC Range: 34°C - 42.2°C
- Tempus IC Accuracy: ±0.2°C (36-39°C) ±0.3°C (39°C)
- Comparison: Both use third-party Bluetooth tympanic thermometers; technology in Tempus IC2 remains substantially equivalent.
2. Sample size used for the test set and the data provenance
The document mentions "Comparative testing has been performed using calibrated patient simulation equipment." This suggests that the testing was likely performed on simulated data/equipment rather than human patients. Details regarding the specific sample size of these simulations or data provenance (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. The testing described uses "calibrated patient simulation equipment," implying a ground truth established by the simulator's settings, not by human experts.
4. Adjudication method for the test set
Not applicable, as ground truth was established by calibrated patient simulation equipment, not expert consensus.
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 is mentioned in the provided text. The device is a patient monitor, not an AI diagnostic tool involving human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "comparative testing" with "calibrated patient simulation equipment" could be considered a form of standalone performance assessment against a known simulated ground truth for the vital sign parameters. However, it's not described as an "algorithm only" study in the context of advanced AI diagnostics. The device itself is a measurement tool.
7. The type of ground truth used
The ground truth for the vital sign measurements was established by "calibrated patient simulation equipment."
8. The sample size for the training set
Not applicable. The document discusses device verification and validation against predicate devices and standards, not the training of an AI algorithm from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI training set.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).