(90 days)
The TM2000 FetalTrace Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring of patient Fetal/Maternal parameters. The System enables receiving, storing, displaying, updating, printing and retransmitting of patient Fetal/Maternal parameters and other patient related data. (such as demographics, doctors, medical history and status, diagnoses, etc.).
The TM2000 FetalTrace Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of the Fetal/Maternal parameters of patients.
The TM2000 FetalTrace Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring of patient Fetal/Maternal parameters. The System enables receiving, storing, displaying, updating, printing and retransmitting of patient Fetal/Maternal parameters and other patient related data. (such as demographics, doctors, medical history and status, diagnoses, etc.).
Operational Characteristics, Features and Functions:
- Runs on any MS Windows operating system
- Maximum database file size of 2 GB. Storage of up to 10 - 40 thousand transmissions (depending on transmitter type)
- Accessing and updating the receiving center DB. Manual entry of patient and physician detail
- Receiving and processing patients' transmitted signals and medical data
- Graphic representation of FM signals
- Intuitive, user friendly HMI
- Capability for signal/data transmission over Web (Planned for implementation in future)
- Localization
- Reports generation
- Reports previewing and printing
- Manageable security, fail-safe protection against unauthorized access. Discretionary access control, restrictions based on privileges (Not yet implemented)
The provided text describes the TM2000 FetalTrace Transtelephonic Receiving Center, a software system for remote monitoring of fetal/maternal parameters. However, it does not contain a detailed study demonstrating device performance against specific acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (TM2000 K013879 Receiving Center) and addressing regulatory requirements for a 510(k) Premarket Notification.
Here's an analysis based on the information provided, highlighting what's present and absent regarding acceptance criteria and a detailed study:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as a table with specific performance metrics (e.g., accuracy, sensitivity, specificity, or response times for data processing). The document mentions "testing was conducted to verify the system compliance with all its design specifications" (page 4), but these specifications themselves are not detailed.
- Reported Device Performance: No quantitative performance metrics are provided. The "Conclusion" states: "The system constitutes a safe and reliable means for receiving, storing, displaying, analyzing, updating, printing and re-transmitting of patient Fetal/Maternal parameters and other patient related data. Its operation present no adverse health effect or safety risks to patients when used as intended." (page 4). This is a qualitative statement of intended function and safety, not a quantified performance report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not mention any test dataset, its size, or its provenance.
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. Since there's no mention of a test set or specific performance evaluation, there's no information about experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or ground truth establishment process is described.
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 device is a "Receiving Center" software for processing and displaying fetal/maternal parameters, not an AI-assisted diagnostic tool for human readers in the typical MRMC study context. There's no mention of AI assistance or comparative effectiveness studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. While the device is software that performs tasks like receiving, storing, and displaying data automatically, the document doesn't detail a "standalone" performance study in the sense of evaluating an algorithm's diagnostic accuracy or automated interpretation without human intervention. The focus is on the functionality and safety of the system as a whole.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. As no specific performance study with a test set is detailed, the type of ground truth is not mentioned. The device deals with "Fetal/Maternal parameters," which implies objective physiological data, but how the correctness of the processing or display of this data was validated isn't specified in terms of ground truth.
8. The sample size for the training set
- Not applicable / Not provided. The document does not describe any machine learning or AI components that would require a "training set." The system's purpose outlined is data handling (receiving, storing, displaying, etc.).
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set is mentioned.
Summary of what is present and relevant to "study" information:
The document describes the TM2000 FetalTrace Transtelephonic Receiving Center as a software system designed to handle remote fetal/maternal monitoring data. It states that "testing was conducted to verify the system compliance with all its design specifications" within the framework of "Design Controls and Hazard Analysis." The system was determined to be a "moderate level of concern system." The overall conclusion is that it is a "safe and reliable means" and "present no adverse health effect or safety risks."
However, this is presented at a high level and acts as a declaration of compliance rather than a detailed report of a performance study with specific acceptance criteria, methodologies, or quantitative results. The provided information is typical for a 510(k) submission seeking substantial equivalence, emphasizing functional characteristics and safety over a detailed, quantitative performance validation study against defined acceptance metrics.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).