Search Results

The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.

The SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is a general purpose, Track 1, ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The Beluga1™ is an ultrasound imaging probe that has been ergonomically designed for use in intraoperative procedures.

The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software. The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image. The Beluga1™ Imaging Probe has been developed for specific application in spine procedures.

The provided text does not contain detailed acceptance criteria for a specific device performance metric (like accuracy, sensitivity, specificity, etc.) that would typically be presented in a table alongside reported device performance. Instead, it describes general performance and safety testing against recognized standards.

Here's an analysis of the information available regarding acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence by conforming to recognized industry standards for safety and performance, rather than specific performance metrics (e.g., accuracy, sensitivity, specificity) for a particular clinical task.

• Acceptance Criteria (Implied by Conformity to Standards):

  • Electromagnetic disturbances requirements and tests (IEC 60601-1-2: 4th edition)
  • Safety requirements for electrical equipment (IEC 60601-1-1: 2005/(R)2012 And A1:2012)
  • Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37 ED 2.1 2015)
  • Determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359 Ed 2.1 2017-09)
  • Acoustic output measurement standard for diagnostic ultrasound equipment (NEMA UD 2 revision 3 2009)
  • Temperature rise of the device (in accordance with IEC 60601-2-37 ED 2.1 2015)
  • Biocompatibility (ISO 10993-1 5th edition 2018-08, specifically cytotoxicity, sensitization, irritation or intracutaneous reactivity tests for the medical device category of the transducer)
  • Sterilization (ISO 14937:2009)

• Reported Device Performance:
  The document states that the "SonoVision™ Ultrasound Imaging System was evaluated for performance, acoustic output, biocompatibility, cleaning and sterilization as well as thermal, electromagnetic, and mechanical safety, and found to conform with the following FDA recognized standards." This implies that the device met the acceptance criteria set by these standards. However, no specific numerical performance metrics (e.g., specific dB levels, temperature ranges, or quantitative biocompatibility results) are provided in the summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "In vivo testing was conducted to demonstrate performance of the device in human applications." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

The document does not describe an MRMC study or the use of AI assistance in improving human reader performance. The device is described as an "Ultrasound Imaging System" with "image processing software that can be used to define anatomical features," but not explicitly an AI/CAD product in the context of comparative effectiveness with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not explicitly detailed. The device is a general-purpose ultrasound system, and while it has "image processing software that can be used to define anatomical features," the summary doesn't present it as a standalone algorithm being evaluated independently of operator use. The "in vivo testing" likely involved human operators.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "In vivo testing... in human applications," the type of ground truth used is not specified. For the engineering and biocompatibility tests, the "ground truth" would be the successful adherence to the parameters and thresholds defined by the referenced standards (e.g., IEC, ISO, NEMA).

8. The sample size for the training set

The document does not mention a training set, as it describes a medical device (ultrasound system) rather than a machine learning algorithm requiring a distinct training phase.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned.

Ask a specific question about this device

Sonovision is a software application intended for capturing, viewing, archiving and management of images and study data, acquired from Ultrasound machine and other similar medical imaging systems, when installed on suitable commercial standard hardware.

Sonovision is intended for use by obstetricians, gynecologists, radiologists, ultrasound technicians and cardiologists. The system is designed for use in hospitals, medical imaging labs and medical offices.

Sonovision works as Workstation Software for Ultrasound Image Acquisition, Study Management, Reporting, Sending Studies to PACS Server or Making DICOM CD/DVD.

Sonovision is an Ultrasound Imaging Solution/Ultrasound Workstation Software for images Acquisition. Study Management & Reporting.

Sonovision capture's images and video clips from Ultrasound machine and save uncompressed images along with patient information to local database.

• Saving, searching and loading Studies into secure local Database .
• Save Studies as DICOM File, Image Files(JPG, J2K, TIFF and PNG) & Ultrasound . Reports
• Send or Retrieve Studies to PACS Server over the network .
• Make DICOM CD or DICOM DVD .
• Use computer printer to print ultrasound images .
• Image Zooming, Panning, Flipping, Rotating Options .
• Add Text Annotations on Images .
• Record Video Clips and covert them into DICOM Series/frames .

Sonovision does NOT use lossy (irreversible) compression during image handling, manipulation or storage in local Database (It creates uncompressed TIFF Files). However when user converts images or series to DICOM or other Image formats(like JPG, PNG) manually then it may apply lossy (irreversible) compression on images.

All hardware used by Sonovision 2.0 (Including computer, storage drives, network interfaces, video capture cards, monitors and printers) are commercial off-the-shelf equipment

The provided text from the 510(k) Premarket Notification for Sonovision 2.0 is a summary document primarily focused on demonstrating substantial equivalence to existing predicate devices. It does not contain details about a study to prove acceptance criteria or specific performance metrics in the way typically expected for an AI/ML medical device.

The document describes Sonovision v2.0 as an ultrasound workstation software for image acquisition, review, reporting, and archiving. Its primary functions are:

• Capturing images and video clips from ultrasound machines.
• Saving, searching, and loading studies into a local database.
• Saving studies as DICOM files, image files (JPG, J2K, TIFF, PNG), and ultrasound reports.
• Sending or retrieving studies to a PACS server.
• Making DICOM CDs or DVDs.
• Printing ultrasound images.
• Image manipulation (Zooming, Panning, Flipping, Rotating, Text Annotations).
• Recording video clips and converting them into DICOM series/frames.

Since this is a software for image handling and not an AI/ML algorithm for image analysis or diagnosis, the type of "acceptance criteria" and "study" described in the prompt's questions (e.g., accuracy, sensitivity, specificity, expert consensus, MRMC studies) are not applicable to this device as presented in the 510(k) summary. The acceptance criteria for such a system would typically revolve around functional performance, data integrity, compatibility, and user interface usability, rather than diagnostic accuracy.

Therefore, the following information is not available in the provided text:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone performance (algorithm only) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

In summary, the provided 510(k) document for Sonovision 2.0 does not include the type of detailed performance study information typically required for AI/ML diagnostic or prognostic devices as it is an image processing and management system, not a diagnostic algorithm. The "substantial equivalence" demonstration relies on comparing its features and intended use to legally marketed predicate devices, not on a clinical performance study with specific metrics like sensitivity or specificity.

Ask a specific question about this device