(66 days)
The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patients' home on the order of a physician.
The Sense4Baby Model B+ is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (nonstress) testing. The system transmits the measured data to a gateway device, and then a HIPAA-Compliant web based portal for storage and physician review.
The Sense4Baby System Model B+ is a perinatal monitoring system. The provided text details its safety and performance testing to demonstrate substantial equivalence to a predicate device, the Phillips/HP Series 50XM Fetal Monitor.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for specific performance metrics (e.g., accuracy of fetal heart rate detection). Instead, the acceptance criteria for performance are generally stated as achieving "substantial equivalence" to the predicate device. The reported performance is a declaration that these criteria have been met through various tests.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance, functionality, and reliability. | "Verification and validation activities established the performance, functionality, and reliability characteristics of the device with respect to the predicate." |
| "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results demonstrated substantial equivalence." | |
| Compliance with applicable voluntary safety standards. | "The Sense4 Baby System Model B+ complies with applicable voluntary safety standards..." |
| "Safety testing performed... demonstrated that the Sense4Baby System Model B+ is as safe and effective as the predicate device." | |
| Minimization of hazards from hardware and software errors. | "The possibility of hazards arising from hardware and software errors was further minimized in compliance with ISO 14971:2007 and ISO 13485:2003." |
2. Sample Size for Test Set and Data Provenance
The provided text does not contain information about a specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily "bench testing" and "simulated use testing," rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a clinical test set with patient data is not described in the provided sections, there is no information regarding experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no clinical test set with human assessment is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described in the provided text. The submission focuses on demonstrating substantial equivalence through bench and simulated use testing against a predicate device, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The provided text describes "Software testing" as part of the performance bench testing. However, it does not provide details of a standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for the algorithm itself, without human intervention. The focus is on overall system performance meeting predicate specifications.
7. Type of Ground Truth Used
For the described "Performance Testing (Bench)" and "Simulated Use testing," the "ground truth" implicitly refers to the established specifications and functionalities of the predicate device. The goal was to demonstrate that the Sense4Baby system's performance, functionality, and reliability matched or were equivalent to these predicate specifications.
8. Sample Size for the Training Set
The provided text does not contain any information about a training set or its sample size. This submission focuses on hardware and software verification and validation, not on the development or training of an AI/machine learning algorithm with a distinct training dataset.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth would have been 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).