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The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, intraoperative and etc.

The ACCUVIX V10 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The ACCUVIX V10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

Here's a breakdown of the acceptance criteria and study information for the ACCUVIX V10 Diagnostic Ultrasound System, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification summary for substantial equivalence. It does not contain detailed information about a "study that proves the device meets the acceptance criteria" in the way one might expect for a clinical trial validating an AI algorithm. Instead, it describes how the device meets safety and performance standards and is substantially equivalent to previously cleared predicate devices. Therefore, the "acceptance criteria" here refer to regulatory and safety standards, and "device performance" relates to its intended uses and modes of operation, which are compared to the predicate devices. There is no information about AI-specific validation studies, as this device predates such common regulations.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACCUVIX V10 are based on its compliance with established safety standards and its substantial equivalence to predicate devices, particularly regarding its intended uses and modes of operation. The device performance is deemed acceptable if it meets these existing standards and offers functionalities comparable to or improved over the predicate devices.

Table 1: Acceptance Criteria (Regulatory Standards) and Reported Device Performance

Study Information (Based on the 510(k) Summary)

As this is a 510(k) Pre-Market Notification for a diagnostic ultrasound system (filed in 2009), the "study" referred to is a demonstration of substantial equivalence to legally marketed predicate devices, rather than a clinical trial validating a new AI algorithm's performance against a ground truth.

There is no information in the provided document for the following points, as these types of studies and details are typically associated with performance validation of novel AI/ML devices, which is not the nature of this submission:

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a 510(k) substantial equivalence submission for an ultrasound system. The demonstration of equivalence relies on device specifications, technical characteristics, and safety standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 document is for a general diagnostic ultrasound system, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies as understood today.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of "Study" in this Context:

The "study" or justification for approval in this 510(k) is the demonstration that the ACCUVIX V10 Diagnostic Ultrasound System is substantially equivalent to the following predicate devices:

• K070813, ACCUVIX V10 Diagnostic Ultrasound System
• K092159, ACCUVIX V20 Diagnostic Ultrasound System

Substantial equivalence is established by showing that the device has the same intended use and similar technological characteristics as the predicates, or if there are differences, that these differences do not raise new questions of safety and effectiveness. The document extensively lists safety standards the device meets and its various modes of operation and clinical applications, comparing them to what was previously cleared in the predicate devices. The presence of 'P' (previously cleared) and 'N' (new indication) for various transducers and clinical applications illustrates this comparison to the predicate devices.

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