Search Results

Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).

Fibroid Mapping Reviewer Application (FMRA) is a software that allows the user to load an existing ultrasound data into the application for calibration, review, annotation and generation of a 3D rendered uterus model. It aids in the measurement of fibroid dimensions and mapping the location of fibroids in the uterus.

The ultrasound data of the patient's uterus, exported from ultrasound equipment via storage media such as a USB drive, is loaded into the proposed software. The user marks the anatomical features of the uterus and the fibroid. The software post-processes the 2D volume ultrasound images of the uterus to obtain the mapping & measurement of fibroids which are represented in a 3D rendered uterus model. It allows the clinician to know the parameters of each fibroid (like fibroid size and location) by just selecting a fibroid in the model.

The proposed device is intended to assist qualified physicians in accurate diagnosis and planning of image guided interventional of uterine fibroids.

Here's a breakdown of the acceptance criteria and study details for the Fibroid Mapping Reviewer Application (FMRA) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the total number of cases or patients used in the test set. It mentions "phantom models (i.e., incorporating simulated uterus and fibroids)" and that "input images for FMRA were also collected from 3 different ultrasound machines." This implies the test data was generated using phantom models.
• Data Provenance: The test data was generated using phantom models (simulated uterus and fibroids). The images for FMRA input were collected from 3 different ultrasound machines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: 3 certified medical professionals.
• Qualifications of Experts: They are referred to as "certified medical professionals." Specific qualifications (e.g., radiologist, years of experience) are not provided in this document.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It states "Validation testing was executed by 3 certified medical professionals," implying that these professionals were involved in the validation process, likely comparing FMRA output to MRI values and assessing if the acceptance criteria were met. There's no mention of a consensus or tie-breaking mechanism.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly mentioned or described. The study focused on validating the FMRA's accuracy against MRI, not on human reader performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the described validation is essentially a standalone (algorithm-only) performance study. The FMRA's output (spatial coordinates and fibroid dimensions) was directly compared against ground truth established by MRI values, with the "certified medical professionals" acting as evaluators of this comparison rather than integrating FMRA into a human workflow.

7. The Type of Ground Truth Used

• Ground Truth Type: MRI (Magnetic Resonance Imaging) values are considered the "gold standard for imaging" and were used as the ground truth.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. It focuses on the validation of the device after its development.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. It only describes the ground truth for the validation (test) set.

Ask a specific question about this device