(15 days)
The TM2005 Personal Medical Phone™ software system is designed to manage data from remote patients and physicians. The system users are patients, physicians and administrators. Each user has a unique access to database according to his permissions in the system.
The system enables the user to connect to the Internet Server, view and update data according to the user permissions, download data via PDA or PC. This includes ECG, and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.).
An external means (CGTTM) is provided for displaying, measuring, and printing the downloaded ECG.
The system includes a DB Management application and a means to receive data via Internet. It also provides auxiliary tools to enable the administrator to add users, set user permissions, link between users (patients/doctors and a Backup utility).
The Personal Medical Phone™ Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG) parameters of cardiac patients.
The TM2005 Personal Medical Phone™ software system is designed to manage data from remote patients and physicians. The system users are patients, physicians and administrators. Each user has a unique access to database according to his permissions in the system.
The system enables the user to connect to the Internet Server, view and update data according to the user permissions, download data via PDA or PC. This includes ECG, and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.).
An external means (CGTTM) is provided for displaying, measuring, and printing the downloaded ECG.
The system includes a DB Management application and a means to receive data via Internet. It also provides auxiliary tools to enable the administrator to add users, set user permissions, link between users (patients/doctors and a Backup utility).
The provided documentation is a 510(k) Premarket Notification for the TM2005 Personal Medical Phone™ Center. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain information about acceptance criteria for device performance, nor a study proving the device meets them, as typically found for novel device approvals. Instead, it focuses on demonstrating that the TM2005 is substantially equivalent to a previously approved predicate device (TM2000 Receiving Center K992164) and meets relevant safety standards.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A) - This document does not specify performance acceptance criteria for diagnostic accuracy or efficacy. The submission is a 510(k) for substantial equivalence, focusing on safety and technological similarities to a predicate device, rather than novel performance claims requiring specific acceptance thresholds. | N/A - No specific device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures are reported as part of a study to meet acceptance criteria. |
2. Sample size used for the test set and the data provenance
- N/A. The document does not describe a clinical performance study with a test set. The submission is based on substantial equivalence to a predicate device and adherence to safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As no clinical performance study with a test set is described, there is no mention of experts or ground truth establishment for such a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. No clinical performance study with a test set 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
- N/A. The device is described as a system to manage, receive, store, display, and re-transmit patient ECG and other related data. It is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. The device is a data management system, not an algorithm with standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. As no clinical performance study is described, there is no mention of ground truth types.
8. The sample size for the training set
- N/A. The document does not describe a machine learning algorithm or an AI training set.
9. How the ground truth for the training set was established
- N/A. As no machine learning training set is described, there is no information on how its ground truth would be established.
Summary of the K024365 510(k) Submission:
The TM2005 Personal Medical Phone™ Center is a software system designed to manage remote patient and physician data, including ECG and other patient-related information. It enables users to connect to an Internet server, view/update data, and download data. An external means (CGTTM) is mentioned for displaying, measuring, and printing downloaded ECGs.
The submission is a Special 510(k) based on substantial equivalence to the predicate device, the TM2000 Receiving Center (K992164). The primary difference noted is that TM2000 is a DB server, while TM2005 is a web server supporting JSP files, which the submitter claims has "no effect on safety, and are intended to improve the system effectiveness."
Conclusions on Safety and Effectiveness:
The document concludes that the TM2005 system is a "safe and reliable means for receiving, storing, displaying, updating, and re-transmitting of patient ECG and other patient related data." It states that its operation presents "no adverse health effect or safety risks to patients when used as intended." This conclusion is derived from a "rigorous design evaluation and the System Safety and Risk analysis," which categorized the device as a "moderate level of concern system." The manufacturer also states conformance with various medical device standards (e.g., IEC 601-1, ISO 9002) and FDA guidances.
In essence, this 510(k) notification demonstrates substantial equivalence primarily through technical comparison to a predicate device and adherence to recognized safety and quality standards, rather than through a clinical performance study with defined acceptance criteria.
§ 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).