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The DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-780A 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.

The provided FDA 510(k) Premarket Notification for the Toshiba Aplio™ MX (v1.0) SSA-780A Ultrasound System (K092948) does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/CADe device would.

This document is a submission for a diagnostic ultrasound system, which falls under general controls and requires demonstration of substantial equivalence to a legally marketed predicate device. The information provided heavily focuses on intended use statements for various transducers and operational modes, rather than performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested fields cannot be extracted or are not applicable in the context of this 510(k) submission for a general ultrasound system.

Here's a breakdown of the information that can be gleaned and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided document in the form of specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity) and corresponding reported device performance metrics. The document instead lists the clinical applications and modes of operation for various transducers, largely stating that these are "previously cleared by FDA" or "new indications" for specific modes. The "performance" is implicitly tied to substantial equivalence to the predicate device and compliance with relevant standards.

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

Not provided. This type of detail would typically be found in a clinical performance study report, which is not part of this 510(k) summary (or likely not required for a Class II ultrasound system that isn't a CADe device).

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/Not provided. Since there's no mention of a specific test set or ground truth establishment in a clinical performance study context, this information is not available.

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

Not applicable/Not provided. As there is no test set or ground truth establishment described, no adjudication method would be relevant or mentioned.

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/Not provided. The Aplio™ MX (v1.0) SSA-780A is a diagnostic ultrasound system, not an AI/CADe device that assists human readers. Therefore, an MRMC comparative effectiveness study with AI assistance would not be relevant.

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

Not applicable/Not provided. This device is a general diagnostic ultrasound system, not an algorithm.

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

Not applicable/Not provided. No explicit ground truth is mentioned for performance evaluation in a clinical study context. The substantial equivalence is based on the device's technical specifications and intended use being similar to predicate devices, and compliance with standards like IEC 60601-1 and AIUM-NEMA.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of an algorithm or a training set for machine learning in this submission.

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

Not applicable/Not provided. There is no mention of an algorithm or a training set for machine learning in this submission.

Summary of what is available in the document regarding "acceptance" (understood as compliance and intended use):

The document details the Intended Use for the Aplio™ MX (v1.0) SSA-780A Ultrasound System across various transducers and clinical applications. The "acceptance criteria" in this context are implicitly that the device is safe and effective for these indications, and that it is substantially equivalent to predicate devices. This equivalence is demonstrated by compliance with international standards and direct comparison of features and intended uses.

The study that proves the device meets these (implicit) acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence. This is not a clinical performance study with quantitative results, but rather a regulatory demonstration based on technical specifications, intended uses, and compliance with recognized standards.

Implicit Acceptance Criteria (based on the document):

• Conformance to Standards: The device is designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1 (and its parts -1-1, -1-2, -1-4, -2-37), IEC 62304, AIUM-NEMA UD2, and AIUM-NEMA UD3.
• Substantial Equivalence: The device is substantially equivalent to predicate devices (Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO XG MODEL SSA-790A v4.0R001 - K092179 and v4.0 - K091295) for shared indications and modes of operation.
• New Indications Performance (implied): For "new indications" (marked with 'N' in the tables) or newly added modes/features, the implication is that their safety and effectiveness are established through standard ultrasound engineering verification, validation, and potentially pre-clinical or limited clinical evaluation to demonstrate they function as intended and do not raise new questions of safety or effectiveness compared to predicate devices for similar applications.

Reported Device Performance (based on the document, interpreted as intended capabilities):

The device performance is reported through the detailed "Intended Use" tables for the system and each transducer. These tables specify:

• Clinical Applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult/Pediatric), Transvaginal, Transesophageal (non-Cardiac/Cardiac), Musculo-skeletal (Conventional/Superficial), Peripheral vessel, Trans-rectal.
• Modes of Operation: B, M, PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, Combined (e.g., B/M, B/PWD, BDF/PWD, BDF/MDF, BDF/MDF/PWD, 2D/CWD, BDF/CWD), THI (Tissue Harmonic Imaging), Dynamic Flow, Power, CHI 2D, 4D.
• Other Features: TDI, ApliPure, MicroPure, Precision Imaging, STIC, 3D Color (Volume Color), STIC Color, Elastography.

The "P" (previously cleared) and "N" (new indication) markers in the tables indicate which clinical applications and modes have been previously cleared or are new to this device/submission.

In summary, for a diagnostic ultrasound system like the Aplio MX, "acceptance criteria are generally addressed through conformance to recognized standards, established intended uses, and demonstration of substantial equivalence to existing predicate devices, rather than through specific quantitative performance targets from dedicated clinical trials for each feature.

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