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The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.

The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

This is a 510(k) premarket notification for an ultrasound system, not a study evaluating an AI device or a diagnostic test. Therefore, the traditional acceptance criteria and study design details often found in submissions for AI/ML-enabled devices or new diagnostic tests are not explicitly present in the provided document.

The document primarily focuses on establishing substantial equivalence to previously cleared devices for various clinical applications and operational modes of the Toshiba APLIO Ultrasound System (SSA-770A) and its associated transducers. The "acceptance criteria" here refer to the regulatory requirement of demonstrating that the device is as safe and effective as a legally marketed predicate device. The "study" described is the 510(k) submission process itself, which relies on comparison to predicate devices and adherence to relevant industry standards and regulations.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth) are not applicable in the context of this 510(k) submission as it is not a performance study for a novel algorithm or diagnostic metric.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices, adhering to recognized standards, and ensuring the device's technical specifications and intended uses fall within acceptable parameters for diagnostic ultrasound systems. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices for the specified indications.

The tables within the document describe the intended clinical applications and modes of operation for the SSA-770A system and each of its transducers. A "P" indicates "Previously Cleared by FDA" for that application/mode, while "E" indicates "Added under Appendix E (LTF)" (likely referring to the FDA's "Least Technologically Advanced" guidance for substantial equivalence). This means the device meets the "acceptance criteria" for these applications by demonstrating they are equivalent to or derived from previously cleared functionalities.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document is a 510(k) premarket notification for an ultrasound system, not a clinical performance study with a test set of patient data. The regulatory approval is based on substantial equivalence to predicate devices and adherence to relevant standards for diagnostic ultrasound. There is no mention of a specific "test set" of patient data in the context of validating algorithmic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As per point 2, there is no explicit test set or ground truth establishment by experts described in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As per point 2, no test set requiring adjudication is described.

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 a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI-related comparative effectiveness is mentioned or relevant here.

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

• Not Applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no "standalone algorithm" performance assessed in this context.

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

• Not Applicable. There is no mention of ground truth in the context of validating a diagnostic algorithm's performance. The "ground truth" for this submission is effectively the established safety and effectiveness of the identified predicate devices and compliance with regulatory standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable. As per point 8, there is no training set, and therefore no ground truth establishment for a training set.

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