(115 days)
The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. The BirthTrack Workflow and measurements cycle have not changed with this version and signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations. However signal analysis was enhanced with a new algorithm- a "side inclination" correction algorithm. The system's GUI was also enhanced introducing a graphic illustration of CD and HS as measured by the BirthTrack system
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The document is primarily a 510(k) summary for the BirthTrack System, outlining its intended use, previous clearance, description, and substantial equivalence to predicate devices, but lacks the detailed performance study information requested.
Therefore, many of the requested fields cannot be filled.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states "Substantial Equivalence: Based on bench studies and clinical evaluation..." but does not detail the specific performance metrics or acceptance criteria used in those evaluations, nor does it report the device's performance against them.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. There is no mention of human readers or improved performance with AI assistance.
6. Standalone Performance Study (Algorithm Only)
The document mentions "bench studies and clinical evaluation" and that "signal analysis was enhanced with a new algorithm- a 'side inclination' correction algorithm." This suggests that the algorithm's performance was evaluated, but the details of a standalone study (e.g., metrics, results) are not provided.
7. Type of Ground Truth Used
This information is not provided in the document. The device measures cervical dilation and fetal head station, implying that a ground truth for these measurements would be obtained from clinical assessments (e.g., manual vaginal examinations). However, how this ground truth was collected and used in the reported "bench studies and clinical evaluation" is not detailed.
8. Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document.
§ 884.2800 Computerized Labor Monitoring System.
(a)
Identification. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.(b)
Classification. Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.