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The Ultrasound System SONIMAGE MX1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination.

The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal, cardiac, and peripheral vascular.

This device is intended for use in healthcare facilities, such as health clinics and hospitals.

Intended user for the device are physician, sonographer, and other trained qualified healthcare professionals.

Modes of operation include B-mode, PWD-mode, CWD-mode, Color Doppler-mode, Power Doppler-mode, and their Combined mode.

The Ultrasound System SONIMAGE MX1 is a portable diagnostic ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation.

This system provides ultrasound images in conventional modes of B-mode, M-mode, Color Doppler-mode, Power Doppler-mode, PW Doppler-mode and CW Doppler-mode.

The optional items are available, such as a Cradle, a Three port probe unit, an Additional Battery, and a Foot Switch with dual/triple pedals.

The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP.

This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications and are brought into contact with the body surface.

The provided text is a 510(k) summary for the Konica Minolta Ultrasound System SONIMAGE MX1. It does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria through a human-in-the-loop or standalone AI study.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K180084). The "Performance Data" section primarily lists compliance with various medical device standards (e.g., AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, IEC 62304) and references relevant FDA guidance documents for diagnostic ultrasound systems, software, and cybersecurity.

The key statement regarding performance is: "Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device." This indicates that the device's performance was evaluated through engineering verification and validation (V&V) activities against technical specifications and established standards, rather than clinical studies involving human readers or AI algorithms with specific performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information because it is not present in the provided document. The document describes a regulatory submission based on substantial equivalence, relying on standard compliance and V&V activities, not a performance study as typically seen for AI/ML-driven devices requiring clinical validation against defined acceptance criteria.

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The Ultrasound System SONIMAGE MX1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal, and peripheral vascular.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The Ultrasound System SONIMAGE MX1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation.

This system provides ultrasound images in conventional modes of Bmode, Color Doppler-mode, and PW Doppler-mode.

The optional items are available, such as a Cradle, an Additional Battery, a Three port probe unit, and a Foot Switch with dual/triple pedals.

The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP.

This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.

This document is a 510(k) Premarket Notification from Konica Minolta, Inc. for their Ultrasound System SONIMAGE MX1. It does not describe a study involving an AI/CADe device or an MRMC study. Instead, it is a submission for a conventional ultrasound diagnostic system, demonstrating substantial equivalence to a predicate device based on technological characteristics and bench tests.

Therefore, many of the requested criteria related to AI/CADe acceptance, MRMC studies, ground truth establishment for AI training/test sets, and expert adjudication are not applicable to the information provided in this document.

However, I can extract the relevant information regarding the device's acceptance criteria and the type of study performed to prove its conformity.

Acceptance Criteria and Study for Ultrasound System SONIMAGE MX1

Based on the provided text, the acceptance criteria and the study conducted are focused on demonstrating substantial equivalence to a previously cleared predicate device (K162065 - Ultrasound System SONIMAGE HS1), rather than a clinical trial proving specific performance metrics of an AI system.

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

The document does not provide a quantitative table of acceptance criteria with corresponding performance metrics as one might find for an AI/CADe system (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating:

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

• Test Set Sample Size: Not applicable in the context of human data. The "study" here refers to "Bench-tests" for accuracy verification. No human subject data test set is described.
• Data Provenance: Not applicable. The "study" is a series of non-clinical bench tests (e.g., phantom studies) to verify performance characteristics.

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

• Not applicable. This is a conventional ultrasound device, not an AI/CADe system requiring expert-adjudicated image ground truth for performance evaluation on patient data. The "ground truth" for the bench tests would be the known physical properties of the testing phantoms or simulated signals.

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

• Not applicable. No multi-reader adjudication process is described as it's a bench test of device specifications.

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

• No MRMC study was done. This is not an AI/CADe device; it's a diagnostic ultrasound system.
• The document explicitly states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment."

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

• Not applicable, as this is a conventional diagnostic ultrasound system, not an AI algorithm. Its performance is inherent in its imaging capabilities (B-mode, Doppler, etc.).

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

• For the non-clinical "Bench-tests," the ground truth would be known physical parameters/measurements of the phantoms or calibrated test equipment used for geometric accuracy, position, velocity, and time verification.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve a machine learning training set.

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