(98 days)
The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-recal, Trans-vaginal, Muscularive, Pedialit, Sinan Organis, Neonalia, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The ACCUVIX XG is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler image and Colopher the Gala as B mode, W mode, W mode, Color Doppler imaging, 3D imaging mode (real time 4D ) imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The ACCUVIX XG also gives the operator the ability to measure anatomical structures and offers and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX XC has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) Premarket Notification summary for the ACCUVIX XG Diagnostic Ultrasound System and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices rather than directly proving performance against acceptance criteria for a novel AI device. Therefore, much of the requested information regarding AI device-specific performance studies is not present.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the context of performance metrics for an AI algorithm, nor does it report performance against such criteria. The device is a diagnostic ultrasound system seeking substantial equivalence to predicate devices, focusing on safety standards and intended uses.
The "performance" described relates to the device's adherence to various product safety standards. The document states:
"The ACCUVIX XG has been designed to met the following product safety standards:"
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- EC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- NEMALID -1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
2. Sample size used for the test set and the data provenance
Not applicable. This is a traditional medical device submission (ultrasound system), not an AI device that would typically involve a test set for algorithm performance evaluation. The "test set" in this context would refer to internal validation of adherence to safety and performance standards, likely using physical testing on the device itself and its components, rather than a dataset of patient images. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device submission for demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not an AI device requiring ground truth for algorithm performance, no experts were used in this specific context for establishing ground truth of a test set. The validation would be against established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned, as this is related to a traditional medical device demonstrating substantial equivalence, not an AI algorithm evaluation.
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. This is not an AI device, so no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ACCUVIX XG is a diagnostic ultrasound system, which inherently involves a human operator (human-in-the-loop) for image acquisition, interpretation, and diagnosis. It is not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this document pertains to the substantial equivalence of an ultrasound imaging device, the "ground truth" relates to compliance with engineering, safety, and acoustic output standards, rather than clinical diagnoses established by expert consensus, pathology, or outcomes data for an AI algorithm.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no mention of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no training set mentioned, and therefore no method for establishing ground truth for a training set.
§ 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.