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The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. 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), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), 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 Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner 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.

The Clarius Ultrasound Scanner system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals, including the emergency medical services (EMS) environment. The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.

The Clarius Scanner PAL HD3 ("PAL HD3") (subject device of this 510(k) premarket notification) is a multipurpose dual-array transducer that incorporates high-frequency linear array (equivalent to the L15 HD3 transducer cleared under K213436)) and low-frequency phased array (equivalent to the PA HD3 transducer cleared under K213436) ultrasound functionalities where the two separate transducer ceramics are arranged side-by-side within the same transducer model (PAL HD3). The Clarius Scanner PAL HD3 is a new Clarius HD3 transducer variant introduced into the HD3 product line of the Clarius Ultrasound Scanner device family and represents a design modification to the existing PA HD3 transducer of the Clarius Ultrasound Scanner system, which was most recently 510(k)-cleared under K213436.

The Clarius Scanner PAL HD3 has two separate transducer ceramics positioned side-by-side which consist of the linear array and the phased array. The Clarius Scanner PAL HD3 offers a wide frequency range of 1 – 15 MHz within a single transducer. The body and electronics of the PAL HD3 scanner are identical to the currently released HD3 scanner models (the PA HD3 and the L15 HD3) of the Clarius Ultrasound Scanner device family (cleared under K213436); the main difference is in the scanner head. The Clarius Scanner PAL HD3 will allow clinicians to switch between the phased array and the linear array without having to use two separate scanners during exams and procedures.

The Clarius Ultrasound Scanner, subject of this 510(k) premarket notification, comprises the following:
Transducer/ Scanner: PAL HD3
Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android
Accessories: Clarius Charger HD3; Clarius Power Fan HD3

The provided document, a 510(k) Premarket Notification from the FDA to Clarius Mobile Health Corp., does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, it is a clearance letter from the FDA stating that the new device, the Clarius Ultrasound Scanner with the PAL HD3 transducer, has been found "substantially equivalent" to a previously marketed predicate device (K213436). The document explicitly states:

"The Clarius Ultrasound Scanner (PAL HD3 transducer model) did not require clinical studies to support the determination of substantial equivalence."

This means that a detailed clinical performance study with defined acceptance criteria, test sets, expert adjudication, or MRMC studies, as requested in your prompt, was not performed or submitted for this specific 510(k) clearance due to the nature of the "substantial equivalence" determination for this device modification.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance: No such data is present.
2. Sample size used for the test set and data provenance: No test set described.
3. Number of experts and qualifications for ground truthing: No ground truthing process described.
4. Adjudication method for the test set: No adjudication described.
5. MRMC comparative effectiveness study results: No such study was done.
6. Standalone (algorithm only) performance: This device is an ultrasound scanner, not an AI algorithm.
7. Type of ground truth used: No ground truth used as no clinical study was performed.
8. Sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set in the context of clinical performance.
9. How ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use: The new device has the same indications for use as the predicate.
• Comparison of Technological Characteristics: The new device (PAL HD3) combines two transducer types (phased array and linear array) that were already present in separate models of the predicate device (PA HD3 and L15 HD3). The body and electronics are identical.
• Compliance with Recognized Standards: The device underwent non-clinical performance testing to demonstrate compliance with relevant safety and performance standards (e.g., IEC 60601 series, ISO 14971) indicating electrical safety, EMC, usability, and acoustic output.

In summary, the provided text explains why a detailed clinical performance study with acceptance criteria was not required for this 510(k) clearance, rather than describing such a study.

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The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. 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), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.

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

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner 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.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.

The Clarius Ultrasound Scanner comprises the following:
Transducers/ Scanners (various models): C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3
Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android
Accessories: Clarius Charger, Clarius Fan

This document does not contain information about acceptance criteria or specific study results for the Clarius Ultrasound Scanner related to diagnostic accuracy performance metrics (e.g., sensitivity, specificity, AUC).

The provided text from the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Intended Use and Indications for Use: These are identical between the subject and predicate devices.
• Technological Characteristics: Principle of operation, transducer types, software, modes of operation, wireless communication, and portability are similar. The only noted difference is the power source (internal integrated for the subject device vs. removable for the predicate).
• Compliance with Recognized Standards: Both devices comply with a comprehensive list of medical device safety, EMC, usability, and acoustic output standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2 & 3, IEC 62304, IEC 62366-1, ISO 14971).

The "Non-Clinical Performance Testing" section broadly states that "The device's safety and performance were verified by tests conducted by Clarius and accredited third-party laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device." However, it does not provide specific acceptance criteria or quantitative performance results from these tests. These tests likely pertain to the engineering and safety standards listed, rather than diagnostic performance metrics typically associated with AI/ML devices.

Therefore, I cannot provide the requested information from the given text, particularly regarding a table of acceptance criteria and reported device performance (in terms of diagnostic accuracy), details on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The device described is a general diagnostic ultrasound system, not an AI/ML-driven diagnostic aid that would typically have such performance criteria explicitly detailed in a 510(k) summary for clinical performance.

Ask a specific question about this device

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. 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), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), 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 Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner 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.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system with various transducers. The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

The reported performance of the subject device (Clarius Ultrasound Scanner) is identical to the predicate device (Clarius Ultrasound Scanner, K180799) across all listed criteria, indicating substantial equivalence.

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

The provided document does not mention a specific "test set" or its sample size for evaluating the performance of the new transducer models. The study primarily relies on demonstrating substantial equivalence to a previously cleared predicate device.

• Data Provenance: Not explicitly stated for a dedicated test set. The submission focuses on nonclinical performance data related to compliance with various international standards, rather than direct human subject testing for the new transducer models.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The document states that "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence." Therefore, no experts were used to establish ground truth for a clinical test set. The substantial equivalence argument is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication was conducted or described in the provided information.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed as per the provided document. The submission focuses on comparing the new device models to a predicate device based on technical and functional equivalence.

6. Standalone Performance Study (Algorithm Only):

The document does not describe a standalone algorithm-only performance study. The "Clarius Ultrasound Scanner" is described as a comprehensive ultrasound imaging system, not a device primarily driven by an AI algorithm requiring standalone performance evaluation in the context of this submission. The device is software-based but its performance evaluation within this 510(k) submission is related to hardware compliance and functional equivalence, not AI-driven diagnostic performance that would necessitate standalone algorithm studies.

7. Type of Ground Truth Used:

Not applicable. As clinical testing was not required for substantial equivalence, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the evaluation of the subject device in this submission. The "ground truth" for the device's capabilities is implicitly established by its adherence to recognized industry standards for medical electrical equipment and its equivalence to the predicate device’s established performance.

8. Sample Size for the Training Set:

Not applicable. The provided information relates to a 510(k) submission for new transducer models, demonstrating substantial equivalence to a predicate device. It does not mention machine learning or AI models requiring a training set for diagnostic or analytical performance.

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

Not applicable, as no training set for a machine learning or AI model was mentioned in the provided text.

Ask a specific question about this device

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. 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), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), 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 Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf iOS or Android device. The Clarius Ultrasound Scanner 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 into electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external 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 is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The Clarius Ultrasound System product/package components include:

1. Software:
   . The Clarius Ultrasound App (Clarius App) for iOS; OR
   The Clarius Ultrasound App (Clarius App) for Android. ●
2. Transducers/Scanners:
   Clarius Scanner C3 (C3 Convex Transducer);
   . Clarius Scanner EC7 (EC7 Convex Endocavitary Transducer);
   Clarius Scanner C7 (C7 Convex Transducer); OR ●
   Clarius Scanner L7 (L7 Linear Transducer).
3. Accessories:
   a. Clarius-Built:
   o Battery Pack (Li-ion);
   Battery Charger; O
   Clarius Dock (Optional; charging station); and O
   Clarius Fan (Optional). O
   b. OEM/Off-the-Shelf Product(s):
   Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; O Model Number ME20A1203B02; approved in the US); and
   Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power o adaptor from MEAN WELL Enterprises Co., Ltd.; Model Number GSM160B12-R7B; approved in the US).

The concept of the Clarius Ultrasound System transducers and software is to provide an easy to use, highperformance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound Scanner 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 Clarius Ultrasound Scanner is a diagnostic ultrasound system. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, thus demonstrating it meets acceptance criteria through a comparison study rather than independent performance testing against predefined metrics.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are not directly stated as quantitative performance metrics (e.g., sensitivity, specificity for a specific diagnostic task). Instead, the device's acceptance is based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means the device performs at a level comparable to, or as safely and effectively as, the predicate devices for its intended use, without raising new questions of safety or effectiveness.

The "reported device performance" is implicitly demonstrated through its substantial equivalence to the predicate devices and compliance with relevant nonclinical performance standards.

The table below outlines the comparison criteria used to establish substantial equivalence, which serves as the framework for acceptance.

Study Proving Acceptance Criteria

The study described is a comparison study for substantial equivalence under the FDA's 510(k) pathway. It demonstrates that the Clarius Ultrasound Scanner does not introduce any new technology or indications for use that differ significantly from legally marketed predicate devices, thus concluding that it is substantially equivalent in safety and effectiveness.

1. Sample size used for the test set and the data provenance:

   • The document states: "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence to the predicate devices indicated."
   • Therefore, there was no separate "test set" of clinical data for the subject device to quantify its performance against specific acceptance criteria. The equivalence is established by comparing the design, technological characteristics, intended use, and indications for use of the subject device to the previously cleared predicate devices.
   • The provenance of data for the predicate devices is not detailed in this document.

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

   • Since no clinical testing was performed for the subject device, no experts were used to establish ground truth for a test set in the context of this 510(k) summary. The "ground truth" for the predicate devices' clearance would have been established during their respective regulatory processes, not during this submission.

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

   • Not applicable as no clinical test set requiring adjudication was used for this submission.

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 comparative effectiveness study was done, as this submission did not involve clinical performance testing of the device's diagnostic accuracy or the impact of AI assistance on human readers. The device is purely an imaging system; the provided document does not mention AI components for image analysis or interpretation.

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

   • Not applicable. This is an ultrasound imaging system, and the document focuses on establishing substantial equivalence based on hardware, software, intended use, and modes of operation, not on an algorithm's standalone diagnostic performance. No AI algorithm in a standalone capacity is mentioned.

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

   • For the purposes of this 510(k) submission, the "ground truth" for acceptance is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances. The subject device is deemed safe and effective because it is substantially equivalent to these already cleared devices, not through new clinical ground truth establishment for its own performance.

7. The sample size for the training set:

   • Not applicable. The document does not describe any machine learning components that would require a "training set" of data for this device.

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

   • Not applicable. As there is no described training set, there methods for establishing ground truth for it are absent.

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