(239 days)
The HP Series 50 OB TraceVue is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive obstetrical surveillance of up to 30 patients at central station, all bedsides, nurses' lounges, physicians' lounges and offices. The HP Series 50 OB TraceVue allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alerting and optional storage. The specific medical indication for use of this device is: This device is a prescription device. This device is not intended to contact the patient. This device is used continuously in Obstetrical Departments Basic and advanced fetal trace alerting for both antepartum and intrapartum applications. The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information during obstetrical period, and to document relevant information (surveillance) as needed by care providers.
The Series 50 OB TraceVue is intended to replace the former HP Obstetrical Information Management System 80235B and M1370A. TraceVue combines the features of the former devices with the features of new PC technologies. The HP Series 50 OB TraceVue allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alerting and optional storage. The modular system approach of the HP Series 50 OB TraceVue offers the flexibility to build a stand-alone solution or to create complete networks that provide a monitoring and alerting solution for the entire OB department. It replaces traditional OBGYN paper Charts/Records with a configurable computerized version that has the capability to automatically gather data from various sources, enter the data, and then visually display the data in a comprehensive manner. In addition it offers applications that support clinical decisionmaking, care management, Continuous Quality Improvement (CQI), and research. The patient population includes those patients monitored on HP predicate devices. The hardware for this system is off-the-shelf PCs and servers which meet the performance specification identified.
The provided text describes the HP Series 50 OB TraceVue, an Obstetrical Surveillance and Archiving System. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement of compliance. This summary will extract the available information and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hardware Safety: Compliance with relevant safety standards for ITE devices (UL 1950, IEC 950, EN 60950). | The safety of this PC device is shown by compliance to relevant safety standards for ITE devices such as UL 1950, IEC 950, EN 60950 for the hardware. |
| Software Safety: Verified by Hazard analysis and software validation to ensure the product performs as intended. | Software safety is verified by Hazard analysis and software validation to ensure the product performs as intended. |
| Electrical Safety: System electrical safety and interface driver compatibility requirements. | The electrical Safety requirements for the System as well as the compatibility requirements for the Interface Drivers have been carefully validated and successfull tested. The results have proved that Trace Vue meets these requirements. |
| Intended Use Equivalence: Performance data indicating substantial equivalence to legally marketed predicate devices regarding safety, effectiveness, and intended use. | Description statements were mainly not relied on to show substantial equivalence to legally marketed devices: instead, performance data from device validation is used as well. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety effectiveness and intended use. |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error rates for clinical decision-making support features, if any).
- Detailed quantitative performance results for clinical functions (e.g., accuracy of alerting, data transfer reliability, or display fidelity). The document only states that requirements were "met" or tests were "successful."
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the document.
- Sample Size for Test Set: Not mentioned.
- Data Provenance (country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts and their Qualifications for Ground Truth
This information is not provided in the document. There is no mention of experts establishing ground truth for any test set. The validation seems to rely on technical compliance and comparison to predicate devices rather than clinical performance evaluation against expert consensus.
4. Adjudication Method for the Test Set
This information is not provided in the document. As there's no mention of a test set evaluated by experts, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device is described as an information management system that aids clinical decision-making, not a diagnostic AI tool that directly improves human reader performance in interpreting images or traces.
6. Standalone (Algorithm Only) Performance
This information is not explicitly provided in the document in the context of an "algorithm only" performance study. The document focuses on the system as a whole, integrating data from various sources and providing surveillance and alerting. While it mentions "applications that support clinical decisionmaking," it doesn't isolate and test the performance of these "applications" as standalone algorithms. The "software validation" mentioned is for ensuring the product performs "as intended," which is broad.
7. Type of Ground Truth Used
The primary "ground truth" used for validation appears to be:
- Compliance with safety standards: For hardware and electrical safety.
- Functional performance to design intent: For software validation and meeting electrical safety/compatibility requirements.
- Substantial equivalence to predicate devices: For intended use and technological features.
There is no mention of clinical ground truth such as expert consensus, pathology, or outcomes data being used to evaluate the device's accuracy in specific clinical tasks (e.g., detecting fetal distress, predicting outcomes). The device's role is described as gathering, storing, displaying data, and offering alerts, implying its validation was more about reliability and functionality rather than diagnostic accuracy.
8. Sample Size for the Training Set
This information is not provided in the document. The document refers to "validation" but does not detail a machine learning training process or sample sizes for such.
9. How Ground Truth for the Training Set Was Established
This information is not provided in the document, as there is no mention of a traditional machine learning training set or associated ground truth establishment.
§ 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).