(268 days)
Horizon Perinatal Care Surveillance and Archival System is intended for use as a central monitoring system, providing fetal surveillance and monitoring of multiple obstetrical and fetal patients simultaneously and to correlate pertinent patient observations of physiological parameters.
Horizon Perinatal Care Surveillance and Archival's indications for use are:
- . Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
- . Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and
- . Provides remote access to the HPC S&A system.
The Horizon Perinatal Care Surveillance and Archival System consists of the Horizon Perinatal Care Surveillance and Archival software, which runs on standard "off-the-shell" hardware components (e.g., servers and workstations). Horizon Perinatal Care Surveillance and Archival uses standard 100 Mbps Ethernet networking technology and is coupled to industry standard fetal monitors that are legally marketed under FDA regulations. Each fetal monitor is attached to a networked computer. Horizon Perinatal Care Surveillance and Archival is able to interface with other pertinent hospital information systems.
The provided 510(k) summary for the "McKesson Information Solutions, LLC's Horizon Perinatal Care Surveillance and Archival System" does not contain detailed information about specific acceptance criteria, a quantitative study proving performance against those criteria, or the methodology typically associated with a clinical validation study for an AI-powered device.
Instead, the summary emphasizes verification and validation testing to ensure the system met specifications and performed as intended, leading to a determination of substantial equivalence with a predicate device (LMS Medical Systems, Ltd., CALM (K980719)).
Here's a breakdown of the information that can be extracted, and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states: "Verification and validation testing was performed on Horizon Perinatal Care Surveillance and Archival to ensure it met all specifications. The system was further validated to ensure that it performs as intended. In all instances, Horizon Perinatal Care Surveillance and Archival System functioned as intended and the results observed demonstrate substantial equivalence with the predicate device."
This indicates that internal specifications were met, and functional testing was successful, but specific quantitative performance metrics against defined acceptance criteria (e.g., sensitivity, specificity, accuracy for a detection task, or specific timing/latency metrics for a surveillance system) are not included.
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 describes "verification and validation testing" but does not detail the nature, size, or provenance of any test sets used.
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 provided. Given that this device is a "Perinatal Care Surveillance and Archival System" rather than an AI diagnostic tool, the concept of "ground truth" established by experts for a test set in the conventional sense (e.g., for disease detection) is likely not applicable or not presented in this summary. The validation would have focused on functional correctness, data integrity, and adherence to specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided.
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 mentioned. This device is a "Surveillance and Archival System," not an AI-powered diagnostic or decision support tool meant to be used by human readers in a comparative effectiveness study. Its primary function is to interface with monitors, display data, document, and archive.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not mentioned in the context of an AI algorithm. The system's performance would be evaluated on its ability to correctly acquire, display, and archive data from medical devices, not on a standalone diagnostic algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified in the context of clinical "ground truth" for a diagnostic task. The "ground truth" for this system would likely relate to the accuracy of data acquisition, display, and archiving compared to the source data from the fetal and maternal monitors, or to the expected behavior of a properly functioning software system.
8. The sample size for the training set
Not applicable. This device is described as a software system running on "off-the-shell" hardware, performing functions of surveillance, monitoring, display, and archiving. It is not presented as an AI/ML device that requires a training set in the typical sense for learning patterns or making predictions.
9. How the ground truth for the training set was established
Not applicable, as there is no indication of a training set for an AI/ML model for this device.
Summary of what the document does provide:
- Intended Use: Central monitoring system for fetal surveillance and monitoring of multiple obstetrical and fetal patients, correlating physiological parameters.
- Indications for Use: Interfaces with fetal/maternal monitors, provides surveillance, monitors labor progress, displays and archives functions; allows electronic documentation and storage of patient information; provides remote access.
- Technological Characteristics: Software running on standard hardware, uses standard Ethernet, interfaces with industry-standard, legally marketed fetal monitors, and can interface with other hospital information systems.
- Predicate Device: LMS Medical Systems, Ltd., CALM (K980719).
- Performance Claim: "In all instances, Horizon Perinatal Care Surveillance and Archival System functioned as intended and the results observed demonstrate substantial equivalence with the predicate device."
- Basis for Substantial Equivalence: Same intended use, indications for use, technological characteristics, and principles of operation as the predicate. Minor technological differences raise no new safety/effectiveness issues. Verification and validation testing demonstrated it functioned as intended.
The document focuses on the functional verification and validation of a software system against its specifications and its similarity to a predicate device, rather than a clinical performance study with specific quantitative acceptance criteria typically seen for AI/ML diagnostic or predictive devices.
§ 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).