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The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gvnecology, Obstetric. Cardiac, Small parts. Urology, Musculosketal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.

Acclarix AX3 Series/ Acclarix LX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text describes a 510(k) premarket notification for a Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove a device meets those criteria for novel technology.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not available in this document. The document primarily focuses on explaining how the new device is similar to already approved ultrasound systems and transducers.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in terms of specific performance metrics with acceptance criteria and their corresponding reported values. Instead, the document claims substantial equivalence to predicate devices based on:

• Intended Use/Indications for Use
• Mode of Operations
• Design principles
• Hardware and software platforms
• Transducer types
• Acoustic Output (stated to be below FDA limits)
• Materials of transducers and needle guide brackets

2. Sample size used for the test set and data provenance:

• Test Set Sample Size: Not provided. The document states "Clinical testing is not required" and primarily relies on non-clinical tests and comparison to predicate devices.
• Data Provenance: The document implies that the "clinical applications" and "imaging modes" added to the new device are based on what was already cleared for the Acclarix LX9 series (K192879) and other predicate devices (K200232 and K201693). This suggests a reliance on retrospective data and established performance of predicate devices, rather than new prospective clinical trials for this specific submission. The origin of the data for the predicate devices is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not applicable. Since clinical testing was not required for this submission, there was no separate test set requiring new ground truth establishment by experts for specific AI algorithm performance.

4. Adjudication method for the test set:

• Not applicable. No specific adjudication method is mentioned as there was no dedicated clinical test set described for new performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No, an MRMC study was NOT done. The document explicitly states "Clinical testing is not required" and focuses on substantial equivalence based on technical specifications and previously cleared indications. There is no mention of human readers or AI assistance.

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

• Not applicable. This document is for a diagnostic ultrasound system, not an AI algorithm. While the system may employ internal processing (which could include algorithmic components), the submission does not detail testing of standalone AI performance against a ground truth.

7. The type of ground truth used:

• Not applicable for novel performance claims. The "ground truth" implicitly relies on the established and cleared performance of the predicate diagnostic ultrasound systems and their associated transducers. The "Acoustic output testing" was done "as per the guideline 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated June 27, 2019," which suggests adherence to industry standards and regulatory guidance for ultrasound device performance, rather than clinical ground truth for a specific medical condition.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or training of a new AI algorithm. It refers to a diagnostic ultrasound system and its transducers.

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

• Not applicable. As no new AI algorithm development is described, there is no training set or ground truth specific to an algorithm's training.

Summary of what the document does provide:

The document serves as a 510(k) submission arguing for the substantial equivalence of the new Edan Instruments Diagnostic Ultrasound Systems (Acclarix AX3 series and Acclarix LX3 series) to existing cleared predicate devices. The arguments are based on:

• Non-clinical performance tests demonstrating compliance with relevant electrical safety, EMC, and acoustic output standards (ANSVAAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10).
• Comparison of intended use, indications for use, mode of operations, design principles, hardware/software platforms, and transducer types to previously cleared Edan Instruments ultrasound systems (K192791, K192879) and other predicate devices (K200232, K201693).
• The argument is that the differences are minor and do not raise new questions of safety or effectiveness. For example, new clinical applications, transducers, and imaging/measurement modes have already been cleared on other predicate devices.

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