(162 days)
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor compatible Reynolds Monitoring products and also to act as a "control panel" for thes that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied with all products. The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated data bases are replaced by the Sentinel database. Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common data base, Sentinel stores data collected from each patient in the section of the database, dedicated to that patient. When used as a method for operating the device, the user selects the iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program. Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later. Sentinel will work on a single computer, but it has been re-configured to be also used in a network
The provided text describes Sentinel, a software product for managing cardiology device databases. It is a Special 510(k) submission, meaning it compares the device to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include specific quantitative acceptance criteria or detailed device performance metrics. Instead, it states:
| Criterion | Acceptance | Reported Device Performance |
|---|---|---|
| Safety and Efficacy | Equivalent to predicate device (DelMar Reynolds CardioNavigator Plus, K051960) | "Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." |
| Functionality | Organize and manage databases for compatible Reynolds Monitoring products, act as a "control panel," and replace dedicated individual product databases. | "Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products." |
| Analysis | No capacity for analyzing electrocardiograms. | "Sentinel has no capacity for analyzing electrocardiograms." (When used with Pathfinder, Pathfinder is loaded separately and called by Sentinel, but with no other control links). |
2. Sample Size for Test Set and Data Provenance
The document does not specify a sample size for a test set. It mentions "extensive validation" but provides no details on the number of cases, patients, or the origin (country, retrospective/prospective) of any data used for testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention any experts being used to establish ground truth. Given that this is a database management and control panel software, the "ground truth" would likely be related to data integrity, successful data transfer, and correct device operation rather than clinical interpretation requiring expert consensus.
4. Adjudication Method
The document does not specify any adjudication method, as there's no mention of expert review or clinical assessment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or reported. The device is a database management system, not an interpretive algorithm that would be used by human readers for diagnosis.
6. Standalone Performance Study
The text states: "Sentinel has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." However, no specific standalone performance study with quantifiable results is described. The validation appears to be functional and integration testing rather than an algorithmic performance study in the typical sense.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Based on the device's function, the "ground truth" would likely relate to:
- Data Integrity: Verifying that data captured by the monitoring devices is correctly and completely stored, retrieved, and displayed by Sentinel.
- Functional Correctness: Ensuring that Sentinel correctly acts as a "control panel" for compatible devices, allowing users to configure devices and receive downloaded data as intended.
- System Compatibility: Confirming that Sentinel works with various compatible Del Mar Reynolds Medical monitoring products.
8. Sample Size for Training Set
The document does not specify a sample size for a training set. This type of software (database management and control panel) typically undergoes software development and functional testing rather than machine learning training that requires a "training set."
9. How Ground Truth for Training Set Was Established
Since there is no mention of a training set for machine learning, the establishment of ground truth for a training set is not applicable to this document. The "ground truth" in the context of this software would be defined by the functional requirements and specifications of the system and its integration with the compatible monitoring devices.
§ 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).