(85 days)
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound system to provide 3D clinical imaging in fetal and gynecological applications. The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations.
Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, and Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, and Segmentation of structures from 3D data.
The provided text is a 510(k) Summary for the SONOReal 3D System, which is a digital ultrasound image analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria.
Based on the provided document, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or provide quantitative performance metrics for the SONOReal 3D System in a study. The summary primarily focuses on comparing the new device (BioMediCom SONOReal 3D System) with a predicate device (EchoTech 3D FreeScan) to establish "substantial equivalence" based on function, hardware, software features, and indications for use.
The relevant comparison table provided is:
| EchoTech (Predicate Device) | BioMediCom (SONOReal 3D System) | |
|---|---|---|
| Trade Name | 3D FreeScan | SONOReal 3D System |
| 510(k) Number | K980308 | K994385 (listed as predicate's number in the table, but K012084 is for SONOReal in this submission) |
| Basic Function | Adds 3D imaging capability to commercial 2D ultrasound imaging systems | Adds 3D imaging capability to commercial 2D ultrasound imaging systems |
| Hardware | Pentium II 400 MHz, Frame Grabber (VHS/S-VHS Input), Video out, Foot pedal | Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, Handheld controller |
| Software features | Volume data acquisition w/frame grabbing of video data b/w while using an Electro magnetic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, Quantitative evaluation, Measurements & calculations | Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, No Quantitative evaluation, No Measurements & calculations |
| Indications for Use | Gynecology/OB, radiology, neurology, gastroenterology, urology, surgery, orthopedics, and oncology | Fetal/Gynecology |
Assessment: The "reported device performance" is essentially the feature set and intended use, which is deemed substantially equivalent to the predicate except for the lack of quantitative measurements and a narrower range of indications for use. There are no numerical performance metrics (e.g., accuracy, precision) provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The focus is on comparison to a predicate device's specifications and functionality.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention any experts being used to establish ground truth for a test set. This type of information would typically be found in a clinical performance study, which is not detailed here.
4. Adjudication Method
The document does not describe any adjudication method. This is consistent with the absence of a detailed performance study involving expert assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The document does not describe an MRMC comparative effectiveness study. It's a 510(k) submission focused on substantial equivalence rather than comparative effectiveness. Therefore, there's no mention of effect size for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study for the algorithm. The device, as described, is a system intended to be used "by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D clinical imaging." It does not provide "quantitative measurement capabilities or diagnostic interpretations" for standalone assessment.
7. The Type of Ground Truth Used
The document does not specify any type of ground truth used for performance evaluation. Given the nature of a 510(k) submission demonstrating substantial equivalence, the "ground truth" for approval is primarily the existence and specifications of a legally marketed predicate device.
8. The Sample Size for the Training Set
The document does not mention any training set size. As a system that does not provide diagnostic interpretations or quantitative measurements, it's unlikely to have been developed using machine learning in the way typically requiring a "training set" for an AI algorithm. Its functions (volume data acquisition, conditioning, surface rendering, segmentation) are described as direct processing tasks.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
Summary of Device Purpose and Approval Context:
The SONOReal 3D System is cleared as substantially equivalent to the EchoTech 3D FreeScan. Its purpose is to add 3D imaging capabilities to existing 2D ultrasound systems for fetal and gynecological applications. Crucially, the document states: "The SONOReal™ system does not currently provide any quantitative measurement capabilities or diagnostic interpretations. It is intended to visualize features that you may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations." This clarification indicates that the device's role is visualization, not automated diagnosis or measurement, which explains the absence of detailed performance studies against specific clinical acceptance criteria in this submission. The FDA's clearance is based on its similarity in function and safety to a predicate device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.