(191 days)
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.
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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)
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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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.