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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 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, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

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This document is a 510(k) clearance letter from the FDA for a new ultrasound system, the KONICA MINOLTA SONIMAGE HS1. It lists the device's indications for use and associated transducers and operating modes. No information about acceptance criteria or a study that proves the device meets specific acceptance criteria for AI performance is present in the provided text.

The document describes the intended use of the ultrasound system for general diagnostic purposes, including various clinical applications such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and cardiac imaging, using different operational modes like B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), and Color Doppler.

Therefore, the requested information cannot be extracted from the given text as it does not pertain to AI performance or related studies.

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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 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, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

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, PW Doppler-mode, and Elastography-mode. It is also capable with Anatomical M-mode, CW Doppler-mode and CF/PW-TDI-mode with Sector transducer. The optional items are available, such as a Pole Cart with storage basket, a power extension 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.

The provided text describes the Konica Minolta Ultrasound System SONIMAGE HS1 and focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about a study evaluating performance metrics (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance) are not present in this document.

However, I can extract information related to the device's technical acceptance and the basis for its clearance.

Acceptance Criteria and Reported Device Performance

The document states that the system's geometric accuracy, elastography position, and the accuracy of position and velocity for various Doppler modes were tested. The "acceptance criteria" here refer to meeting the expectations for these technical characteristics, aligning with existing standards and predicate devices, rather than predefined clinical performance thresholds.

Regarding a "study that proves the device meets the acceptance criteria":

The document explicitly states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment."

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristic comparison and non-clinical testing. The "study" aspects mentioned are primarily non-clinical bench tests.

Here's what can be inferred about the "study" (non-clinical testing) from the provided text:

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

   • The document does not specify a "sample size" for a test set in the context of clinical images or patient data. The evaluations were "bench-tests," implying controlled laboratory settings rather than patient data.
   • Data provenance is not mentioned, but given it's a submission by KONICA MINOLTA, INC. from Japan, the testing would likely have been conducted internally or by relevant testing facilities. The tests are non-clinical, so "retrospective or prospective" is not applicable in the patient data sense.

2. 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 the testing involved "geometric accuracy verification," "position for Elastography-mode," and "accuracy verification of the position and the velocity for Color Doppler-mode, PW/CW Doppler-mode and TDI-mode," the "ground truth" would be established by engineering specifications, calibrated phantoms, and measurement standards, not by human experts interpreting clinical images.

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

   • Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which was not the nature of these non-clinical bench tests.

4. 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 a conventional ultrasound system, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical imaging device operated by a human, not a standalone algorithm.

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

   • The ground truth for the non-clinical tests would be based on physical and engineering measurements against established standards and validated test methods (e.g., using phantoms for spatial accuracy, calibrated flow models for Doppler velocity accuracy).

7. The sample size for the training set:

   • Not applicable. This document describes a medical device clearance based on substantial equivalence and non-clinical engineering tests, not an AI/machine learning model that requires a training set.

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

   • Not applicable (see point 7).

In summary, the provided information outlines a regulatory submission where the Ultrasound System SONIMAGE HS1 demonstrated substantial equivalence to predicate devices through non-clinical bench testing, ensuring adherence to technical specifications, safety standards, and performance characteristics consistent with its intended use as a conventional ultrasound imaging system. Clinical studies were explicitly stated as not required.

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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), peripheral vascular, and Cardiac.

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, Mmode, Color Doppler-mode, and PW/CW Doppler-mode. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual pedals. 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 Konica Minolta Ultrasound System SONIMAGE HS1 and its transducers are medical devices intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The system is substantially equivalent to legally marketed predicate devices (K142197 and K061605).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific numerical performance acceptance criteria in the traditional sense of an original device evaluation. Instead, the "acceptance criteria" are implied by conformity to established standards and proven equivalence to predicate devices, particularly regarding safety and technological characteristics.

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

The document states that non-clinical tests (Bench-tests) were performed. It does not specify a "test set" in terms of patient data or studies. The evaluation is based on comparing engineering and performance specifications to predicate devices and adherence to international standards. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable as per the provided text for this determination of substantial equivalence.

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 applicable as there was no clinical test set described that required expert-established ground truth. The evaluation was based on engineering and performance comparisons.

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

This information is not applicable as there was no clinical test set described requiring adjudication.

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

This information is not applicable. This submission is for an ultrasound system, not an AI-powered diagnostic device, and it does not mention any MRMC study or AI assistance.

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

This information is not applicable. This is an ultrasound imaging system, not an algorithm being evaluated in a standalone capacity.

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

This information is not applicable. The device's performance was demonstrated through non-clinical bench testing and comparison to legally marketed predicate devices, not through a clinical study that would require a ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable. This submission is for an ultrasound system, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable. As no training set for an algorithm was used, no ground truth needed to be established for it.

Ask a specific question about this device

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

• Operating Principle & Design: Transmits ultrasonic energy, performs post-processing of echoes for on-screen display of anatomic structures and dynamics. Laptop-shaped for portability with battery operation. Supports B-mode, M-mode, Color Doppler-mode, and PW Doppler-mode. Supports the same measurement functions.
• Transducers: Uses conventional extracorporeal transducers (Linear and Convex types), partially same as the predicate device. Specific transducers mentioned are L18-4 and C5-2. |
  | Safety and Performance Standards Compliance (Non-clinical Testing) | Conforms to various standards: AAMI / ANSI ES 60601-1: 2005 and C1:2009 and A2:2010; IEC 60601-1-6: 2013; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; IEC 62304: 2006; ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004; NEMA UD 3-2004. These are stated to be the same or equivalent to those of the predicate. Devices conform to real-time display of thermal and mechanical output indices under Track 3. |
  | Non-clinical Test Results | Geometric accuracy in B-mode and accuracy verification of position and velocity for Color Doppler-mode and Pulse Doppler-mode, and time for Pulse Doppler-mode were comprehensively tested as Bench-tests (except quantitative Doppler sensitivity). No quantitative claims of sensitivity regarding Color Doppler-mode and Pulse Doppler-mode were made or required. |
  | Biocompatibility | Patient contact materials for human body surface were evaluated under ISO 10993 and determined acceptable. Achieves the same acceptance level for biocompatibility as the predicate. |

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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