(70 days)
The Telemedicine 2000 (TM2000) Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring ECG, Spirometric and Fetal/Maternal patient parameters.
The enhanced TM2000 enables receiving, storing, displaying, measuring, updating, printing and re-transmitting of patient ECG, Spirometric and Fetal/Maternal parameters and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.), and business information (e.g. billing, inventory sales etc.).
The TM2000 Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG), Spirometric and Fetal/Maternal parameters of patients.
The Telemedicine 2000 (TM2000) Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring ECG, Spirometric and Fetal/Maternal patient parameters.
The enhanced TM2000 enables receiving, storing, displaying, measuring, updating, printing and re-transmitting of patient ECG, Spirometric and Fetal/Maternal parameters and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.), and business information (e.g. billing, inventory sales 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 ECG, Spirometric and FM signals
- Intuitive, user friendly HMI
- Availability for signal/data transmission over Web
- Localization
- Reports generation
- Reports previewing and printing
- Manageable security, fail-safe protection against unauthorized access. Discretionary access control (restrictions based on privileges)
User Interface:
The TM2000 Graphic User Interface (GUI) features pull down menus and dialog boxes for representation and updating of data. Generation of GUI and implementation of the related DB connectivity mechanism shall utilize JVM and the C/C++ native methods in conjunction with the Windows API functions.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the CARD GUARD TM2000 Transtelephonic Receiving Center, focusing on its intended use, classification, regulatory compliance, and a claim of substantial equivalence to a previously cleared device (K992164).
Therefore, I cannot extract the information required for your request, such as a table of acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, or the type of ground truth used.
The document indicates that "testing was conducted to verify the system compliance with all its design specifications" in the "Design Controls and Hazard Analysis" section, but it does not provide details about these tests or their results. It also mentions an evaluation of "device Level of Concern criteria" and a determination that the system is a "moderate level of concern system," but again, no specific criteria or proof of meeting them are given.
The document concludes that the system "constitutes a safe and reliable means" and "present no adverse health effect or safety risks," which are general statements of safety and effectiveness rather than specific performance metrics and their corresponding proof.
§ 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).