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The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), fetal echo, peripheral vessel, carotid, and procedural guidance of needles into the body.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off the-shelf (COTS) iOS or Android device. The Clarius Ultrasound System comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.

Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The Clarius Ultrasound System product/package components include:

1. Software:
   The Ultrasound App (Clarius App) for iOS; OR
   The Ultrasound App (Clarius App) for Android.
2. Transducers/Scanners:
   Clarius C3 Scanner (C3 Convex Transducer);
   Clarius C3 Scanner (C3 Convex Transducer) with Clarius C3-L Clip-on;
   Clarius C7 Scanner (C7 Convex Transducer); OR
   Clarius L7 Scanner (L7 Linear Transducer).
3. Accessories:
   a. Clarius-Built:
   Battery Pack (Li-ion); and
   Battery Charger.
   b. OEM/Off-The-Shelf Product(s):
   Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics, USA; Model Number ME20A1203B02; Approved in the US); and
   Aquasonic 100 Ultrasound Transmission Gel (Off-the-shelf ultrasound gel from Parker Laboratories Inc., USA; Approved in the US).

The concept of the Clarius Ultrasound System transducers and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound System is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.

The provided text describes a 510(k) premarket notification for the Clarius Ultrasound Scanner, indicating that clinical testing was not required to establish substantial equivalence.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria. Specifically, it states:

"The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence." (Page 14)

As a result, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. Information about an MRMC comparative effectiveness study or its effect size.
6. Information about standalone performance (algorithm only).
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices (FUJIFILM SonoSite Edge Ultrasound System K133454 and previous Clarius Ultrasound System K163138) through comparison of technical specifications, intended uses, and modes of operation, and compliance with various nonclinical performance standards like IEC and ISO.

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The Clarus Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Pointof-Care Imaging of Medical Conditions on the general public.

Point-of-Care clinical applications include:

• · Emergency triage exam to look at trauma conditions
• · Procedure guidance to guide needles into the body; and
  · Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-sketal (conventional), musculo-skeletal (superficial), urology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
  · The Clarius Ultrasound System is intended for use in environments where is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.

Users will be trained medical professionals (e.g., doctors, nurses, technicians).

The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-theshelf (COTS) iOS or Android device. The Clarius Ultrasound System comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.

Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The Clarius Ultrasound System includes:
Product/Package Components:

• 1. Software:
  • The Ultrasound App (Clarius App) for iOS; OR
  • The Ultrasound App (Clarius App) for Android ●
• 2. Transducers/Scanners:
  • Clarius Scanner C3 (C3 Convex Transducer); OR ●
  • . Clarius Scanner L7 (L7 Linear Transducer)
• 3. Accessories:
  • a. Clarius-Built:
• Battery Pack (Li-ion) O
• Battery Charger O

OEM/Off-The-Shelf Product(s):
Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics, USA; Model Number ME20A1203B02; Approved in the US.
Aquasonic 100 Ultrasound Transmission Gel (Off-the-shelf ultrasound gel from Parker Laboratories Inc., USA; Approved in the US.

The concept of the Clarius Ultrasound System transducers and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound System is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is not intended for use in Emergency Medical Service, ambulance, or aircraft environments.

The provided text describes the Clarius Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test sets or training sets, data provenance, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

The document primarily focuses on:

• Device Description: What the Clarius Ultrasound System is, its components (software, transducers C3 and L7, accessories), and how it functions as a portable, wireless diagnostic ultrasound system.
• Indications for Use: The medical conditions and applications for which the system is intended (e.g., emergency triage, procedure guidance, various diagnostic applications like fetal, abdominal, small organ, musculoskeletal, urology, gynecology, cardiac, peripheral vessel, pediatric, carotid imaging).
• Contraindications: Situations where the device should not be used.
• Substantial Equivalence: Comparing the Clarius Ultrasound System to three predicate devices (SONON Ultrasound Imaging System, Philips Lumify, and FUJIFILM SonoSite Edge II) to demonstrate that it uses the same fundamental scientific technology and has similar indications for use.
• Non-Clinical Performance Data: Listing compliance with relevant IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, and biological evaluation of medical devices.
• Quality Assurance: General mention of quality assurance measures during design and development.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies based on the provided text. The document is a 510(k) premarket notification summary, which typically focuses on demonstrating substantial equivalence rather than detailing internal performance studies against specific acceptance criteria.

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