(34 days)
ViTelCare™ C-Turtle Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
The ViTelCare™ C-Turtle Patient Monitoring System is a PC based Telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
This 510(k) submission (K060712) for the ViTelCare™ C-Turtle Patient Monitoring System does not contain the kind of detailed study information typically found in submissions for AI/ML-driven devices requiring performance metrics and clinical studies.
The submission focuses on demonstrating substantial equivalence to predicate devices (ViTelCare™ Turtle 400 and Turtle 800) primarily based on combining existing functionalities (monitoring data collection and transmission with added videoconferencing). It asserts that there are "no technical differences with any implications for safety and effectiveness" compared to the predicates.
Therefore, many of the requested categories about acceptance criteria, study design, ground truth, and reader studies are not applicable or cannot be extracted from the provided text.
Here's a breakdown of what can be inferred and what is explicitly not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided. The submission states "no technical differences with any implications for safety and effectiveness" between the C-Turtle and its predicate devices, implying that the performance of the C-Turtle is expected to be equivalent to the already cleared predicates without requiring new performance acceptance criteria or a dedicated performance study for this specific device.
2. Sample size used for the test set and the data provenance
Not applicable. No new performance testing is detailed in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new performance testing is detailed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new performance testing is detailed in this submission.
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. This device is a patient monitoring system for data collection and communication, not an AI/ML-driven diagnostic aid that would involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not described as having a standalone algorithm for diagnostic or interpretive performance. Its function is to collect, manage, and transmit patient data and facilitate videoconferencing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new performance testing is detailed in this submission.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device requiring a training set and established ground truth in this context.
Summary of Device and Rationale for Limited "Study" Information:
The ViTelCare™ C-Turtle Patient Monitoring System is a telemedicine system designed for collecting, managing, and communicating patient monitoring data (vital signs, self-assessment, other physiological data) from home to a remote healthcare practitioner. Its primary new feature noted in this submission is the addition of videoconferencing functionality, combining features already present in two previously cleared predicate devices (ViTelCare™ Turtle 400 and Turtle 800).
The core argument for clearance is substantial equivalence based on the absence of "technical differences with any implications for safety and effectiveness" compared to its predicates. This means the FDA's review primarily focused on:
- Comparing the intended use of the C-Turtle to the predicates.
- Confirming that the technological characteristics (data collection, transmission, videoconferencing) are similar or leverage already-cleared technologies.
- Ensuring appropriate labeling and protocols (derived from VA, DoD, etc.) are included.
Because this submission is for a device combining existing, cleared functionalities without introducing novel diagnostic algorithms or new risks, a detailed clinical study with performance metrics, ground truth, and reader studies (as one would expect for an AI/ML device) was not required or provided.
§ 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).