(55 days)
For obstetrical patients, the OBIX Perinatal Data System 7.0 provides health care professionals a method to display and archive electronic fetal monitor data and manage demographic information and documentation.
The intended use of the OBIX system is displaying and recording fetal and maternal physiological data obtained from electronic fetal monitors. The OBIX system also has these capabilities:
- Monitors fetal and maternal physiological data obtained from standard electronic fetal monitors and accompanying accessories and captures it on permanent storage media.
- Displays the monitored data for one or more patients in the patient rooms and at other locations as required by the hospital.
- Supports patient management activities, including note entry onto the electronic fetal monitor tracings and into the medical record.
- Provides tools that assist clinicians in evaluating fetal heart rate patterns.
- Generates flowsheets and graphs based on the notes recorded for the patient.
- The optional Registration Interface registers patients in the OBIX system directly from the hospital's admissions system. Patients can also be registered in the OBIX system manually, when necessary.
- Displays the Status Board (chalkboard), which shows patient rooms and key data elements in real-time format. The Status Board is typically displayed at one or more central locations, usually at the central nurses' station.
- Provides optional remote access to patient monitoring and management activities through off-site workstations connected by a virtual private network (VPN) connection or a secure hospital Web page.
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The provided document is a 510(k) premarket notification letter from the FDA for the OBIX Perinatal Data System 7.0. It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
However, the document does not contain the detailed information necessary to fully answer the questions about acceptance criteria, study design, and performance. The letter is a regulatory approval, not a scientific study report. It mentions that the FDA reviewed the information provided by the applicant, but the specifics of that information (like detailed study results, ground truth establishment, sample sizes, etc.) are not present in this document.
Therefore, I can only provide general information based on what is typically required for such submissions, and note where the specific data is missing.
Here's an attempt to answer based on the provided text and typical FDA submission requirements, with caveats where information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or reported device performance. The FDA letter confirms the device is substantially equivalent for its intended use, but does not detail the specific performance metrics or the thresholds it met.
The "Indications for Use" section describes the functionalities of the OBIX Perinatal Data System 7.0, which include:
- Monitoring and capturing fetal and maternal physiological data from electronic fetal monitors.
- Displaying monitored data for multiple patients.
- Supporting patient management activities (note entry).
- Providing tools to assist clinicians in evaluating fetal heart rate patterns.
- Generating flowsheets and graphs.
- Optional Registration Interface for patient registration.
- Displaying a real-time Status Board.
- Optional remote access.
To infer acceptance criteria, one would expect the submission to have demonstrated that these functionalities perform as intended, are accurate in their data display and capture, and do not introduce errors that could harm patients. However, the specific quantitative criteria are not in this document.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the performance studies submitted to the FDA, not in the regulatory approval letter itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish ground truth or their qualifications. This information would be part of the clinical or performance validation study details, which are not included here.
4. Adjudication Method for the Test Set
The provided document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided document does not indicate if a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it provide an effect size of how much human readers improve with AI vs. without AI assistance. The OBIX Perinatal Data System 7.0 is described as a "perinatal monitoring system" that "provides tools that assist clinicians in evaluating fetal heart rate patterns." While it assists clinicians, it is not explicitly stated as an AI-powered diagnostic tool that directly improves human reader performance in a quantifiable MRMC study context.
6. If a Standalone Study Was Done
The provided document does not explicitly state if a standalone (algorithm-only without human-in-the-loop performance) study was done. Given the description of the device as a "data system" that displays and records data and "provides tools that assist clinicians," it is likely that the performance assessment focused on the accuracy of data acquisition, display, and archiving, rather than a standalone diagnostic performance of an algorithm.
7. Type of Ground Truth Used
The provided document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data, etc.) for any studies.
8. Sample Size for the Training Set
The provided document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided document does not explain how the ground truth for the training set was established.
§ 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).