(23 days)
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:
| Acceptance Criteria (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Medical Parameter Measurement Efficacy: | |
| * Accurate vital signs measurement | * Not independently proven by clinical tests for the TempusIC™ itself. The claim is based on the use of "currently available (OEM) technology found in many legally marketed devices" and the assertion that the "Tempus 2000 is effectively identical to the devices that incorporate the same OEM technology" (referring to the predicate device). All OEM medical modules and sensors have prior 510(k) clearance and are used as intended. |
| Functional/Feature Performance (non-medical parameter): | |
| * Proper operation of integrated voice link, video camera, data connection | * "The functions and features of the TempusIC™ that are additional to the measurement of medical parameters have been tested and proven by bench and performance testing." (No specific results or acceptance criteria provided in the summary.) |
| Combined PCB and Probe Performance (for desaturation): | |
| * Performance within specification during desaturation | * "a conventional desat study was carried out to verify that the performance of the combined PCB and probe were within specification." (No specific "specification" or results provided.) |
| Ease of Use: | |
| * Meets ease-of-use design objective for trained non-experts | * "User evaluations have been carried out with representative groups of professional, non-professional but trained, and untrained users, to confirm the ease-of-use design objective has been met." (No specific metrics or results provided.) |
| Software Conformance: | |
| * Adherence to FDA's Guidance for Premarket Submissions for Software | * "The requirements of the FDA document Guidance for the Content of Premarket Submissions for Software contained in Medical Devices have been applied." |
| * Adherence to IEC 60601-1-4 | * "In addition, the requirements of IEC 60601-1-4 have been addressed." |
| Safety and Performance (General): | |
| * Conformity to GHTF essential principles | * "The device has been shown to conform to the essential principles for safety and performance defined in guidance prepared by the Global Harmonization Task Force Study Group1 (GHTF/SG1/N14R9:2005)... evidence includes performance testing, software validation, electrical safety, electromagnetic compatibility, and risk analysis." (No specific results provided.) |
| * Comparable to predicate device | * "On the basis of these results and the above referenced testing, it is our determination that the device is safe, effective and performs as well as, or better than, the legally marketed predicate device(s)." (This is a conclusion, not specific performance data.) |
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.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).