(322 days)
The Fetal Monitors are intended for non-invasive monitoring of fetal and maternal physiological parameters during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
The proposed fetal monitors, including F30, F45, F50, F85 and F90 are intended for providing continuous monitoring, displaying, printing and recording of basic fetal and maternal parameters. including uterine activity (UA), dual fetal heart rate (FHR) and fetal movement (ITM), and extended maternal parameters, including electrocardiograph (ECG), non-invasive blood pressure (NIBP) . Pulse Oxygen Saturation (SpO2) , Pulse Rate (PR), Temperature (TEMP) and Respiration Rate (RESI').
This looks like a 510(k) premarket notification for a medical device, which typically does not include detailed clinical study data in the public summary. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device based on technical characteristics and adherence to recognized standards. Therefore, many of your requested details about studies, ground truth, and expert evaluation will likely not be present in this type of document.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table (Table 3-1) where the "acceptance criteria" are implied by compliance with various international standards, and the "reported device performance" is a statement of compliance. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device's medical functions, as the submission relies on demonstrating equivalent technical specifications to a predicate device.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Statement of Compliance) |
|---|---|
| Comply with IEC 60601-1 (Safety) | Comply with IEC 60601-1 |
| Comply with IEC 60601-1-2 (EMC) | Comply with IEC 60601-1-2 |
| Comply with NEMA UD2 (Acoustic Output) | Comply with NEMA UD2 |
| Comply with IEC 60601-1-8 (Alarming) | Comply with IEC 60601-1-8 |
| Biocompatibility (No cytotoxicity, irritation, sensitization) | No cytotoxicity, irritation and sensitization |
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 focuses on non-clinical tests (e.g., electrical safety, EMC, biocompatibility) rather than clinical performance data from a test set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. This information would be relevant for a clinical performance study, which is not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided. This information would be relevant for a clinical performance study, which is not detailed here.
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 provided. This device is a fetal monitor for measuring physiological parameters, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a monitoring system and does not appear to involve a standalone algorithm in the sense of AI performance evaluation. The "non-clinical tests" mentioned (IEC and NEMA standards) are performed on the device itself to verify its design specifications and electrical/biocompatibility safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the context of clinical accuracy. For the non-clinical tests, "ground truth" would be the established specifications and limits defined by the referenced standards (e.g., a specific threshold for electromagnetic emissions, a defined limit for acoustic output).
8. The sample size for the training set
- Not applicable / Not provided. This document describes a traditional medical device (fetal monitor) rather than an AI/ML-based device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set for an AI/ML model is involved here.
§ 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).