(72 days)
The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications. The FETAL ASSIST is specifically intended for use in the following specific areas: - antenatal monitoring in the hospital, doctors office, health clinic, home or community. - External Labour monitoring. - Waterbirth monitoring using optional waterproof transducers. - Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the measurement of uterine activity for women with a history of preterm birth. - Domiciliary Non Stress Testing applications. The FETAL ASSIST is a prescription device.
The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs). CTG traces are displayed in real time on the Liquid Crystal Display (LCD) which is integral to the Host Unit and can be reviewed or downloaded to an external printer and/or central location. The Assist can be powered by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.
The provided text describes the "FETAL ASSIST" device and its intended uses, along with the FDA's acknowledgement of its substantial equivalence to predicate devices. However, the document is a 510(k) summary and FDA clearance letter, which typically does not include detailed study results, acceptance criteria, or performance data in the format requested.
Therefore, much of the requested information regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
Not provided. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria or study outcomes in a quantitative manner. No performance attributes or measurements are mentioned against any acceptance thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document does not mention any specific test set, sample sizes, or data provenance for any studies.
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. No information regarding experts or ground truth establishment for a test set is included.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided. No adjudication method for a test set is mentioned.
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 provided. The "FETAL ASSIST" is described as a fetal monitor that produces and displays cardiotocographs (CTGs). It is not an AI-assisted diagnostic device, and thus, a multi-reader multi-case comparative effectiveness study with AI assistance would not be applicable or expected for this device based on the description.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not provided. The FETAL ASSIST is a monitoring device that generates CTGs for human interpretation. It is not an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided. The document does not discuss the establishment of ground truth as it pertains to performance studies.
8. The sample size for the training set
Not provided. No information about a training set is included, as this is a monitoring device, not a machine learning model.
9. How the ground truth for the training set was established
Not provided. No information about a training set or its ground truth is included.
§ 884.2730 Home uterine activity monitor.
(a)
Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.(b)
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).