(27 days)
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode, M-Mode, Color Flow Doppler Mode, Pulsed Wave Doppler Mode, and E-Mode.
This document is a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It outlines the safety and effectiveness of the UltraVision 2 Diagnostic Ultrasound System by comparing it to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with specific acceptance criteria and outcome metrics for diagnostic accuracy. Substantial equivalence is determined by demonstrating that the new device has the same intended use and operational characteristics, or if different, that these differences do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" here are largely compliance with regulatory standards and similarity to the predicate device in terms of technical specifications and safety.
| Aspect of Acceptance Critera | Description | Reported Device Performance (UltraVision 2) |
|---|---|---|
| Intended Use | The device's intended use must be the same as or within the scope of the predicate device's intended use, and its clinical applications should not raise new safety/effectiveness concerns. | "This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis." This use is "narrowed, but still in the scope of the predicate device." |
| Technological Characteristics & Operational Principles | The device should use the same fundamental scientific technologies and operational characteristics as the predicate device, or any differences should not raise new safety/effectiveness concerns. | Uses "the same fundamental scientific technologies" and supports the "same operating modes (B, CFD, M, E, Shear, PWD) and the same measurement functions for anatomic structures." Operational characteristics (installation, use, power supply) are "the same." |
| Electrical & Mechanical Safety & Thermal Safety Standards | The device must comply with relevant safety standards. | Complies with IEC 60601-1: 2007, IEC 60601-2-37: 2008. |
| EMC Evaluation | The device must comply with electromagnetic compatibility standards. | Complies with IEC 60601-1-2 4th edition. |
| Acoustic Output Evaluation | The device must comply with acoustic output standards. | Complies with IEC 61157 AIUM/NUMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound. |
| Biocompatibility Evaluation | Patient contact materials must be evaluated and determined acceptable under ISO 10993. | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. "Both systems have the same acceptance level for biocompatibility." |
| Disinfection | Disinfection methods for patient-contact parts (probes) must be specified and acceptable. | Probe: .55% Ortho Phthalaldehyde, 2.4% Glutaraldehyde (same as predicate). |
| Performance (Displayed Depth) | Range of displayed depth for imaging. | 20 mm to 300 mm (similar to predicate's .5 cm to 30 cm). |
| Performance (Gray Scales) | Number of gray scales for imaging. | 256 (same as predicate). |
| Performance (2D Measurement Accuracy - Depth/Distance) | Accuracy of distance measurements. | 5% (same as predicate). |
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 explicitly states: "Clinical Test: Clinical testing not required." This indicates that no clinical "test set" in the traditional sense of patient data was used to demonstrate the device's diagnostic performance for its 510(k) clearance. The assessment was based on non-clinical engineering and safety testing, and a comparison of technical specifications to a predicate device. Therefore, information on sample size, data provenance, or study design for diagnostic performance is not applicable here.
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)
Not applicable, as no clinical test set requiring ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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
Not applicable. The UltraVision 2 Diagnostic Ultrasound System is a standalone ultrasound imaging device, not an AI-assisted diagnostic tool. No MRMC study or AI-related performance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The UltraVision 2 is an ultrasound imaging system, not an algorithm. Its performance is evaluated as an imaging device, not as an AI or algorithmic diagnosis tool. The "E-mode" (Elastography) provides a "qualitative representation of relative tissue stiffness," but it is an imaging mode, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth was conducted. The "ground truth" for this submission focuses on compliance with technical and safety standards, as well as the functional equivalence of the device to its predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.