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Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.

Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD). Follicle Clarity automatically calculates the number and size of hypoechoic structures in the received transvaginal ultrasound images and displays the data graphically and in tabular format in the Follicle Clarity application. Graphic displays include both measurements made by the clinician (as measured by the ultrasonographer) as well as those calculated by Follicle Clarity. Graphs can be adjusted for various views of the data. Ultrasound images received are also displayed within the Application to allow the user to verify the resolution, contrast and anatomic completeness. The user is able to enter patient information such as cycle day, estradiol level and progesterone level in the patient profile for tracking. The user also has the ability to add or delete measurements as they feel are appropriate.

The provided text describes the Follicle Clarity Software, a medical device for quantifying ovarian follicles in ultrasound images. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific quantitative thresholds. However, it describes validation activities and states that the device "met the predetermined endpoints" and "demonstrated substantially equivalent performance." Based on the performance data section, the implicit acceptance criteria would likely be a demonstration of accuracy, precision, and agreement with established manual/SonoAVC measurements within a clinically acceptable margin of error.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes for the "second validation trial" (ovaries with ≤ 3 follicles) and "third validation trial" (ovaries with ≥ 10 follicles) or the "prospective study." It broadly refers to "a phantom trial" and "a prospective study."
• Data Provenance: The document only states that the clinical validation was performed in a "prospective study." It does not specify the country of origin.

3. Number of Experts and Qualifications for Ground Truth

• The document implies that "manual measurements" by "ultrasonographer" were used as a basis for comparison in the validation trials.
• For the clinical study, it compares Follicle Clarity to "manual (ultrasonographer) measurements" and "SonoAVC measurements."
• The number of ultrasonographers or their specific qualifications (e.g., years of experience, board certification) are not specified in the provided text.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set. It suggests direct comparison to "manual measurements" and SonoAVC.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly stated as having been done involving human readers improving with AI vs. without AI assistance. The clinical study focused on comparing Follicle Clarity's performance to manual measurements and SonoAVC, not on human-in-the-loop performance improvement with the AI.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was assessed. The "Validation of the tracking and measurement accuracy of the platform was conducted through a phantom trial" and the "second and third validation trials" which compared Follicle Clarity results directly to manual measurements or internal controls appear to be assessments of the algorithm's standalone performance. The clinical study also directly evaluated Follicle Clarity's measurements against SonoAVC and manual measurements without necessarily describing human-AI interaction.

7. Type of Ground Truth Used

• Expert Consensus/Manual Measurements and Predicate Device Output:
  • For the phantom trial and two ovarian follicle validation trials (low and high count), the ground truth appears to be based on "manual measurements of phantom targets" or "manual measurements of follicles" conducted "within a DICOM viewer." This implies expert-derived measurements.
  • For the clinical validation, the algorithm's performance was compared to "manual (ultrasonographer) measurements" and "SonoAVC measurements." SonoAVC is a component of a predicate device (Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System), effectively serving as a form of established clinical truth or a benchmark cleared device.

8. Sample Size for the Training Set

• The document mentions "Machine Learning Algorithm Training" but does not specify the sample size used for the training set.

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

• The document states: "The software utilizes 'locked' (non-adaptive) machine learning algorithms to identify the contours of the targeted structure within the ultrasound image."
• It does not explicitly detail how the ground truth for training data used by these machine learning algorithms was established (e.g., by manual annotation by experts, specific protocols, etc.).

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Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image.

4D View is a standalone Software product. which can be installed on a Laptop/PC with Microsoft Windows 7, Windows 8 and as virtual machine with Windows 7 on MAC operating systems. Primary Operating Functions are:
• Display and editing of 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics).
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM)
• Adding annotations to acquired image

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's 4D View software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance, or specific clinical studies in the way a medical device validation study typically would.

Therefore, based on the provided text, I cannot provide the detailed information requested in your prompt.

Here's why and what the text does say:

• No Acceptance Criteria or Device Performance Metrics: The document states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." This means it wasn't a submission based on demonstrating specific performance against predefined clinical criteria through a new study. Instead, it relied on demonstrating that its fundamental technology, intended use, and safety/effectiveness are the same as an already cleared device.
• No Clinical Study Details: Since clinical studies were not required for this submission, there is no information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training sets.
• Focus on Substantial Equivalence: The document highlights that the 4D View "employsthe same fundamental scientific technology as its predicate device(s)" and that "The Intended Use and Indications for use have not changed from the unmodified device." The modifications introduced are the "ability for 4D View to work with additional GE Ultrasound features and data."

What the document does provide:

• Predicate Device: K101166 4D View and K122327 GE Voluson E6/E8/E8ExpertE10 Diagnostic Ultrasound System.
• Voluntary Standards Compliance: IEC62304, ISO14971, NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing, Final Acceptance Testing. These are general software development and quality control processes, not performance metrics for the device itself.
• Intended Use: "Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image."

To answer your prompt directly, an 510(k) summary for a substantial equivalence determination often does not include the detailed performance criteria and study results you are asking for, especially when clinical studies are not deemed necessary. Such details are more common in PMA (Premarket Approval) applications or 510(k)s where novel technology or new indications require new clinical evidence.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small . Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ E9 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical studies against acceptance criteria.

Therefore, the document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Because no clinical studies were performed, it is not possible to extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document instead focuses on:

• Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety.
• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, and NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Final Acceptance testing (Validation).
• Intended Use: A broad range of diagnostic ultrasound evaluations for various anatomical regions and clinical applications, with specific modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and other features like 3D/4D imaging and needle guidance) listed for each supported transducer.

In summary, the provided text does not contain the information required to populate the table or answer the questions as it pertains to clinical acceptance criteria and a study demonstrating performance against those criteria. The device's clearance was based on demonstrating equivalence, not on de novo clinical performance studies with acceptance criteria.

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