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The Ultrasound System SONIMAGE HS1 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 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 (soft tissue), and peripheral vascular.

The Ultrasound System SONIMAGE HS1 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 all its modes of B-mode, M-mode, Color Doppler-mode, and PW Doppler-mode.

The Konica Minolta Ultrasound System SONIMAGE HS1 (K142197) is a general-purpose portable ultrasound system. Its clearance is based on substantial equivalence to a predicate device (K093171 – Viamo SSA-640A, Toshiba America Medical Systems, Inc.). This type of submission relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device. Therefore, the "acceptance criteria" for this device are implicitly tied to demonstrating that it meets the safety and performance standards of the predicate and other relevant safety standards.

Here's a breakdown of the information based on your request, though it's important to note that a 510(k) summary for a substantial equivalence determination often does not include a detailed "study that proves the device meets acceptance criteria" in the same way a de novo or PMA submission might, especially for performance characteristics that are considered generally well-understood for the device type.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in terms of patient data. The evaluation for substantial equivalence relies primarily on bench testing and compliance with recognized standards. This is a common approach for ultrasound systems where the fundamental imaging technology is well-established.

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

This information is not provided in the document. As this is a 510(k) based on substantial equivalence, the "ground truth" for basic performance characteristics is often established by adherence to industry standards and engineering specifications rather than independent expert clinical review of imaging data for a "test set".

4. Adjudication Method for the Test Set

This information is not applicable/provided. No clinical "test set" requiring adjudication by experts is mentioned in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission specifically states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment." This means that a direct comparison of human readers with and without AI assistance was not part of this clearance process.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device described is an ultrasound imaging system, not an AI algorithm. Its performance is inherent to the hardware and software generating the images and Doppler outputs. It is not an "algorithm only" device.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims (e.g., geometric accuracy, Doppler accuracy) would be defined by engineering specifications, phantom measurements, and adherence to international and national standards (e.g., NEMA UD 2-2004 for acoustic output and safety guidelines). The clinical "ground truth" for diagnostic efficacy is implicitly assumed to be equivalent to that of the predicate device because the underlying technology and intended use are deemed substantially equivalent.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is an ultrasound system, not an AI algorithm that undergoes a "training set" process in the described context of this 510(k) submission.

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

This information is not applicable/provided for the same reason as point 8.

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The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.

The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program

The provided text is a 510(k) summary for a medical device called "CO Pilot" and the associated FDA clearance letter. It states that the CO Pilot is a software intended for installation on REGIUS Unitea (a Picture Archiving Communications System) and provides functions for creating annotations (line, curve, character information), measuring distances and angles, and transferring GUI data. It can process and display images from various modalities but "must not be used for primary image diagnosis in mammography."

The summary explicitly states: "Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized. The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have."

This indicates that Konica Minolta relied on demonstrating substantial equivalence to predicate devices rather than conducting a separate study with specific acceptance criteria and performance metrics for the CO Pilot itself. The summary does not include a detailed study that defines specific acceptance criteria, test sets, ground truth establishment, or multi-reader studies for the CO Pilot's performance. Instead, it argues that its performance is equivalent to already cleared devices through verification and validation activities.

Therefore, many of the requested details cannot be extracted directly from the provided text because these types of studies were not presented in this 510(k) summary as a means to prove the device meets acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of acceptance criteria for the CO Pilot's performance beyond stating that its "function quality" is substantially equivalent to predicate devices. It doesn't report specific performance metrics like sensitivity, specificity, accuracy, or measurement precision for the CO Pilot itself.

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

This information is not provided in the 510(k) summary. The summary refers to "Verification and Validation" but does not detail the datasets or studies used for these activities.

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)

This information is not provided.

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

This information is not provided.

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

A MRMC comparative effectiveness study is not mentioned. The device's primary function is annotation and measurement, not necessarily to assist human readers in diagnosis in a way that would typically be evaluated by an MRMC study demonstrating improved diagnostic accuracy.

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

The document does not describe a standalone performance study in the traditional sense for diagnostic accuracy. The device "primarily facilitates processing and presentation of medical images on display monitors" and provides "display-use annotation" and "measuring" functions. Its performance would likely be assessed on the accuracy of these functions rather than diagnostic output.

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

This information is not provided. Given the device's functions (annotation, measurement), ground truth would likely refer to the accuracy of these measurements relative to a known standard or expert measurement, but the details are not here.

8. The sample size for the training set

This information is not provided. Given the device's functions as annotation and measurement tools, it's less likely to involve a "training set" in the context of machine learning, unless specific automation features exist that weren't elaborated.

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

This information is not provided.

Summary of available information regarding acceptance criteria and study:

The 510(k) summary for CO Pilot (K133730) does not present specific acceptance criteria in a quantitative manner or a detailed study with performance metrics for the device itself. Instead, it relies on demonstrating substantial equivalence to its predicate devices (REGIUS Unitea K071436, Acies K101842, Opal-RAD TM K063337) through "Verification and Validation."

The core argument is:

• Acceptance Criteria (Implicit): The CO Pilot's "function quality," safety, effectiveness, and performance should be equivalent to or not inferior to the legally marketed predicate devices.
• Study Proving Acceptance (Method): "Verification and Validation" activities were conducted. These activities "showed equivalent evaluation outcome with the predicate devices" and confirmed "no impacts in technological characteristics" and "no differences were found" in comparison to the predicates.

No specific data related to test sets, ground truth, expert involvement, or quantitative performance metrics for the CO Pilot itself are provided in this summary.

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