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The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.

Diagnostic Ultrasound imaging of the human body as follows: Abdominal, Pediatric, Small Organ (Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients), Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Includes imaging for needle guidance.

Diagnostic Ultrasound System with Accessories

The provided text is a 510(k) summary for the Diasus Diagnostic Ultrasound System. It primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics for a novel AI device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as it describes a traditional medical device clearance process based on technological equivalence.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the Diasus's characteristics, which are presented as being "comparable" and "substantially equivalent" to the predicates. Specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided, as this is an ultrasound system and not an AI diagnostic device in the modern sense.

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

• Not applicable. This document describes a 510(k) clearance based on substantial equivalence to predicate ultrasound devices. It does not contain information about a test set with patient data for assessing AI algorithm performance. The comparison focuses on hardware specifications, imaging modes, and intended uses.

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

• Not applicable. As above, no test set with ground truth is described.

4. Adjudication method for the test set

• Not applicable.

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 device is a diagnostic ultrasound system, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

• Not applicable. This is a hardware ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No specific ground truth methodology is described or required for this type of 510(k) submission focusing on substantial equivalence of a general ultrasound system.

8. The sample size for the training set

• Not applicable. This document does not describe an AI system with a training set.

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

• Not applicable. This document does not describe an AI system with a training set.

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