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The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

The provided text describes the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. However, it does not explicitly state acceptance criteria in the typical sense of quantitative thresholds for performance metrics. Instead, it outlines the scope of the device's intended use and compares its features and compliance with standards to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, explicit quantitative acceptance criteria are not presented. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, design features, safety standards compliance, and modes of operation.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Clinical testing is not required." This implies that the device's performance was not evaluated through a clinical study with a "test set" of patient data in the typical sense that would involve a sample size and data provenance (country of origin, retrospective/prospective). The assessment is based on non-clinical tests (e.g., engineering benchmarks, compliance with standards) and comparison to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as "Clinical testing is not required." Therefore, there was no "ground truth" for a test set established by experts in this context.

4. Adjudication Method:

Not applicable, as "Clinical testing is not required."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe any MRMC studies or the use of AI. The devices are diagnostic ultrasound systems, not AI-powered diagnostic aids, and the submission is for an updated version of existing devices, primarily focusing on hardware and software updates and expanded indications.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance evaluation without human-in-the-loop.

7. Type of Ground Truth Used:

Not directly applicable in the context of clinical performance evaluation (e.g., pathology, outcomes data). For the purpose of regulatory submission, the "ground truth" for demonstrating substantial equivalence is compliance with established safety and performance standards for diagnostic ultrasound equipment (e.g., acoustic output, electrical safety, biocompatibility) and functional equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device regulatory submission for an ultrasound system, not for an AI/machine learning algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this device in the context of an AI algorithm.

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