(236 days)
The LaborPro System is intended for monitoring the active phase of labor in women with term gestations and a singleton fetus in vertex presentation. The device intermittently assesses fetal head station, position and cervical dilation. Cervical dilation using LaborPro is assessed using position sensors during vaginal examination. The Labor Pro also may be used to measure cervical length, pubic arch angle and interspinous diameter using position sensors during vaginal examination. The LaborPro combines a magnetic tracking system including a transmitter and position sensor with an ultrasound imaging system (not included with the LaborPro). Measurements are displayed numerically and graphically as a function of time to show the progress of labor.
The LaborPro System is comprised of the following components:
- A magnetic based tracking system
- A system console which integrates the tracker unit electronics and the system computer,
- A touch screen monitor, used for display and operation.
- LaborPro software application
- Sensor Sleeve and reference sticker (an "off the shelf" tape and bandage adhesive).
- An 'off the shelf' ultrasound device; not supplied with the system
- An 'off the shelf CardioTocoGram (CTG) monitor (optional); not supplied with the system
LaborPro System, a minimally invasive device, assesses labor The parameters intermittently by accompanying the physician during his/her routine examinations.
The LaborPro magnetic position tracking system is designed for tracking the spatial location of the sensor tip. Spatial localization of landmarks may be simply obtained by either touching external landmarks of interest with the sensor tip and/or by marking structures of interest on a ultrasound image extracted from an "off the shelf" calibrated ultrasound probe aligned with a position sensor. The spatial localization of each sensor then may allow for the assessment of certain measurements such as cervical dilatation simply by touching points within the system's working area and yielding the relative distance/angles between the touched points in a caliper-like fashion. In addition, localization of key anatomical points either by touching external landmarks with a sensor tip or marking structures of interest on an ultrasound image enable mapping of the spatial position and orientation of the pelvis and specifically the level of the pelvic inlet plane; which is used as the relative plane for the fetal head station measurement.
The provided text describes the "LaborPro System," a device intended for monitoring the active phase of labor. However, it does not include a table of acceptance criteria or specific reported device performance metrics tied to such criteria. The document focuses more on establishing substantial equivalence to predicate devices and detailing the general testing performed.
Here's a breakdown of the information that can be extracted, and what is missing based on your request:
Missing Information:
- A table of acceptance criteria and the reported device performance: This crucial information is not present in the provided text. While it mentions "Performance Testing" and a "clinical study to validate the accuracy," specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) and the corresponding test results are not detailed.
- Effect size of how much human readers improve with AI vs without AI assistance (for MRMC comparative effectiveness study): The document does not describe an MRMC comparative effectiveness study involving AI assistance for human readers.
- Sample size for the training set: This information is not provided.
- How the ground truth for the training set was established: This information is not explicitly stated.
Available Information (Categorized as per your request):
1. A table of acceptance criteria and the reported device performance
* Not Available. The document states: "A clinical study was conducted to validate the accuracy of the LaborPro System against two independent experienced attending physicians and/or caregivers (gold-standard). The study results establish the accuracy of the LaborPro System in measuring labor parameters." However, specific numerical performance results or acceptance criteria are not given.
2. Sample sized used for the test set and the data provenance
* Sample Size: Not specified in the provided text.
* Data Provenance: The study was a "clinical study," implying prospective data collection during actual labor monitoring. The country of origin is not explicitly stated for the data itself, but the applicant (Trig Medical Ltd.) is located in Israel. The contact person for Keren Shtiegman, Ph.D., is also in Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Number of Experts: "two independent experienced attending physicians and/or caregivers."
* Qualifications: "experienced attending physicians and/or caregivers" (more specific details like years of experience or board certification are not provided).
4. Adjudication method for the test set
* The document implies a direct comparison to the "gold-standard" established by the two experts, stating the device was validated "against" them. It does not explicitly mention a formal adjudication method like 2+1 or 3+1 for discrepancies between the experts, but rather uses their combined assessment as the ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
* No. The study described is a clinical validation of the device's accuracy against human experts, not a comparative effectiveness study evaluating human readers with vs. without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
* Yes. The "clinical study" described appears to assess the LaborPro System's performance (algorithm only) in measuring labor parameters against the ground truth established by human experts. The device intermittently assesses parameters by "accompanying the physician during his/her routine examinations," suggesting it operates independently to generate measurements that are then compared to expert assessment.
7. The type of ground truth used
* Expert Consensus/Opinion: The ground truth was established by "two independent experienced attending physicians and/or caregivers (gold-standard)."
8. The sample size for the training set
* Not Available. The document does not mention a training set size.
9. How the ground truth for the training set was established
* Not Available. As the training set size or its use is not described, neither is how its ground truth was established.
§ 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.