(73 days)
The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modem, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central site using the same transmission media.
Netlink/Netscan is an accessory to Northeast Monitoring's Holter for Windows Holter Scanner (K930564) that sends recorded cardiac ECG data from remote sites to a central site using standard TCP/IP transfer protocols and where the central site is equipped with Northeast Monitoring's Holter for Windows Holter Scanner for analysis. equipped Monitoring's Holter for Windows Holter Scanner software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data which is analyzed and provides reports on eforms and patterns of consecutive waveforms. The analysis is then returned to the remote site and interpreted by trained medical personnel to diagnose patients with cardiac rhythm patterns.
Netlink/Netscan is an accessory that provides a means to transmit data to and from Northeast Monitoring's Holter for Windows Holter Scanning System . Data can be transferred via modem, cable modems, ISDN lines, T1 lines, DSL, Internet or Intranet. All transferred data is encrypted and is only accessed through a password controlled by the remote and central sites. Netlink/Netscan software contains data checks to prevent the loss or corruption of data during transmission. Nelink/Netscan will resend data if transmission is interrupted.
The provided document is a 510(k) summary for the Netlink/Netscan device, an ECG Transmission System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. The document does not contain information about specific acceptance criteria, comprehensive device performance studies, sample sizes for testing, expert adjudication, or MRMC studies. It mainly compares the technical specifications and transmission methods of the new device with a predicate device.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states, "In summary the performance between the two systems were nearly identical and supports the claim that they are substantially equivalent," but does not provide specific performance metrics or acceptance criteria that were met. The comparison focuses on hardware specifications and transmission modalities.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Nearly identical" performance to predicate device for data transmission capacity and method. |
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe any specific test set or data provenance for a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available. The document does not describe the establishment of ground truth by experts for a test set.
4. Adjudication Method for the Test Set
Not available. The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. The device is a transmission system, not an algorithm providing diagnostic outputs. The "analysis" of ECG data is performed by "Northeast Monitoring's Holter for Windows Holter Scanner software," and then "interpreted by trained medical personnel." The Netlink/Netscan facilitates the transmission of this data.
7. The Type of Ground Truth Used
Not applicable in the context of a diagnostic algorithm. The "ground truth" implicitly refers to the accuracy and integrity of data transmission, not diagnostic accuracy based on expert consensus, pathology, or outcomes data, as this device does not perform diagnosis. The document states that the software "contains data checks to prevent the loss or corruption of data during transmission," implying that the "ground truth" for its function would be successful, uncorrupted data transfer.
8. The Sample Size for the Training Set
Not applicable. The device is a data transmission system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, the device is not an AI/ML model requiring a training set.
§ 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).