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The intended use of the KinetDx, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.

The provided text is a 510(k) summary for the KinetDx Medical Image Management Device, a PACS system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in clinical validation studies.

PACS systems function as image management devices rather than diagnostic algorithms that produce specific findings requiring clinical performance metrics. Their "performance" is generally related to their ability to correctly store, retrieve, display, and process images, and their interoperability with other medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this particular 510(k) summary.

Here's an assessment based on the available information:

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

   • Not provided. This type of 510(k) summary for a PACS device typically focuses on substantial equivalence to predicate devices, and the functional characteristics rather than performance metrics against specific clinical acceptance criteria.

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

   • Not provided. No specific test set for evaluating diagnostic performance is mentioned. The device's "performance" would likely be assessed through engineering verification and validation (e.g., image integrity, speed of retrieval, display accuracy), which are not detailed here.

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):

   • Not applicable. As no clinical performance study involving diagnostic accuracy is described, there's no mention of experts establishing ground truth for such a study.

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

   • Not applicable. No clinical performance study is described.

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:

   • Not applicable. This device (KinetDx) is a PACS system for image management, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's function.

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

   • Not applicable. KinetDx is an image management system, not a standalone diagnostic algorithm.

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

   • Not applicable. No clinical performance study requiring ground truth is described.

8. The sample size for the training set:

   • Not applicable. KinetDx is a PACS system; it does not explicitly use a "training set" in the machine learning sense to develop its core functionality. Its software is developed and tested through traditional software engineering processes.

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

   • Not applicable.

Summary based on available information:

The KinetDx is a Picture Archival and Communications System (PACS). Its 510(k) submission focuses on demonstrating substantial equivalence to predicate PACS devices (EchoLink, ALI UltraPacs, ALI DataComPacs Module) based on technological characteristics (standard computer hardware, proprietary software, Windows 2000 OS, optional DAP card for faster decompression/display) and intended use (acceptance, transfer, display, storage, digital processing, manipulation, and quantification of diagnostic ultrasound, CT, MRI, and X-ray angiography images).

The document does not contain details of specific performance criteria or a clinical study to prove diagnostic accuracy, as this is not the primary function of a PACS system. Its "performance" would be related to its engineering validation and verification, ensuring it reliably manages and displays images as intended and substantially equivalent to predicate devices.

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The intended use of the CSV12 Software Viewer is acceptance, transfer, display, storage, and digital processing of Cypress diagnostic ultrasound images and image manipulation and quantification. No new intended uses are claimed for the modifications.

The intended use of the CSV12 Software Viewer is for the acceptance, transfer, display, storage, and digital processing of Cypress Diagnostic Ultrasound System images, including image manipulation and quantification.

This modification is a software-only version of the Acuson Cypress Diagnostic Ultrasound System Image Viewer and is described as the CSV12 Software Viewer.

The modifications implemented in the CSV12 Viewer Software are to provide off-line image management of ultrasound studies and images on a PC and may be operated independently as a software-only product.

The CSV12 Software Viewer, when running on a personal computer (PC) duplicates the patient database, study storage, viewing, and quantification capability of the Cypress ultrasound system. This provides clinicians with a simple means of viewing studies off-line. Because it can read the full-resolution R-Theta file formats of the Cypress diagnostic ultrasound images, the CSV12 Software Viewer displays images in real-time without any compression, duplicating the original quality of the images on the Cypress diagnostic ultrasound system.

The provided document is a 510(k) summary for a software viewer (CSV12 Software Viewer) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information typically found in a study demonstrating how a device meets acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy).

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The document describes a software viewer that "duplicates the patient database, study storage, viewing, and quantification capability of the Cypress ultrasound system" and "displays images in real-time without any compression, duplicating the original quality of the images on the Cypress diagnostic ultrasound system." The acceptance criteria for such a device would likely focus on functional equivalence (e.g., ability to open and display images, perform measurements accurately compared to the predicate) rather than diagnostic performance metrics like sensitivity or specificity. No specific quantitative performance metrics are provided.

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

This information is not present in the document. The filing discusses the software's capabilities but does not detail a formal test set or its provenance.

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

This information is not present in the document. Since there's no mention of a diagnostic performance study, there's no discussion of ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not present in the document.

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

A MRMC comparative effectiveness study was not done based on the provided document. The filing is for a software viewer and focuses on its functional equivalence, not on improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study focused on diagnostic accuracy is not relevant/not mentioned for this device as it is a viewer. The "standalone" aspect described in the document refers to the software being able to "operate independently as a software-only product" on a PC, duplicating the existing ultrasound system's viewing capabilities, rather than a diagnostic algorithm working independently.

7. Type of Ground Truth Used

Ground truth is not applicable/not mentioned in the context of diagnostic performance criteria for this device as described. The focus is on faithful reproduction and functionality of existing images and data.

8. Sample Size for the Training Set

This information is not present in the document. As this is a software viewer that replicates existing functionality, a "training set" in the context of an AI/machine learning algorithm is not applicable or discussed.

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

This information is not present in the document. See point 8.

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The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

This document is a 510(k) Summary for the Acuson Sequoia Diagnostic Ultrasound System Signature II. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The 510(k) summary focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through adherence to safety standards and a comparison of technological features. It does not include performance metrics or a study demonstrating the device's efficacy or accuracy against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance for market clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications.

The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the Acuson Cypress Ultrasound System, focusing on substantial equivalence to predicate devices and listing intended uses for new transducers. It does not contain performance metrics, study designs, or details on how the device's accuracy or effectiveness was evaluated against specific criteria.

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For use directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The device is specifically indicated for use in visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The company anticipates that the device will be used for a variety of intravascular and intracardiac imaging applications, consistent with its intended use, including vascular stent placement, monitoring left ventricular function post-surgery; identifying congenital abnormalities before therapeutic procedures; visualizing the relative orientation of diagnostic and therapeutic catheters; and visualizing procedures such as transseptal insertions of other catheters, valvuloplasties, balloon septostomies, septal defect closures, and pacemaker or defibrillator lead insertion or extraction.

The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.

The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The AcuNav incorporates a single-use, disposable ultrasonic phased-array imaging transducer, which must be used in conjunction with an Acuson ultrasound imaging platform to generate the acoustic waves and process the information for display to the physician. The catheter is 10 French in diameter and 90 cm in insertable length. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The distal end of the catheter contains the transducer, which is oriented to provide a two-dimensional (90 degree vector) image in a plane parallel to the axis of the catheter. The transducer offers all imaging modes at frequencies between 4.0 and 10.0 MHz.

This 510(k) summary for the AcuNav™ Diagnostic Ultrasound Catheter does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in a quantitative manner. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics against predefined acceptance criteria.

However, based on the provided text, we can infer the overarching "acceptance criterion" to be Substantial Equivalence to the identified predicate devices, meaning the device performs equivalently in terms of safety and effectiveness. The study supporting this is described as performance testing, animal testing, and human clinical testing.

Below is an attempt to structure the information, acknowledging the limitations of the provided text in terms of detailed, quantitative acceptance criteria and study specifics.

Acceptance Criteria and Device Performance

The core acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to predicate devices. This implies that the device's technological characteristics and performance do not raise new questions of safety or effectiveness. The reported "performance" is implicitly deemed equivalent to the predicate devices through the testing conducted.

Study Information

Due to the nature of a 510(k) summary, detailed study parameters are not typically included. The document refers generally to "performance testing, animal testing, and human clinical testing" to support substantial equivalence. Specifics on each of these are absent.

1. Sample size used for the test set and the data provenance: Not specified in the provided text. The document mentions "human clinical testing" but does not provide details on the number of subjects or the geographical origin of the data (e.g., country of origin, retrospective or prospective nature).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

3. Adjudication method for the test set: Not specified in the provided text.

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: Not applicable. This device is an ultrasound catheter, not an AI-powered diagnostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of medical device submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound catheter requiring human operation and interpretation; it is not an algorithm-only standalone diagnostic tool.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For "human clinical testing," the ground truth would typically come from a combination of clinical assessments, other imaging modalities, and potentially pathology or procedural outcomes, but this is not detailed. For "performance testing" and "animal testing," the ground truth would be based on controlled experimental conditions and established biological models.

7. The sample size for the training set: Not applicable. This device is an ultrasound catheter, not a machine learning or AI model that requires a "training set" in the conventional sense.

8. How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device.

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Fetal Assessment CAP@ 1.1 is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional image processing.

Fetal Assessment CAP can import digital 2D or 3D image file formats for 3D display.

The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses.

The Fetal Assessment CAP® 1.1 is a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Fetal Assessment CAP® 1.1 is proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images.

The data can be acquired by a TomTec acquisition station or B-mode (2D) acquisition capable Ultrasound systems. With the Fetal Assessment CAP a 3 dimensional display can be reconstructed.

The provided text describes a 510(k) premarket notification for the "Fetal Assessment CAP® 1.1" software. It focuses primarily on the device description, its intended use, comparison to a predicate device, and a general statement about testing.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

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

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

• Sample Size: Not specified. The document states "Testing was performed according to internal company procedures" and "Software testing and validation were done at the module and system level." This does not provide details on the number of cases or images used.
• Data Provenance: Not specified. There is no mention of where the data came from (e.g., country of origin, specific clinics) or whether it was retrospective or prospective.

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

• This information is not provided in the document. The text only mentions "Test results were reviewed by designated technical professionals before software proceeded to release," but it does not specify the number or qualifications of these professionals, nor does it explicitly state they established "ground truth" for the test set in a medical sense.

4. Adjudication method for the test set

• This information is not provided in the document.

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, an MRMC comparative effectiveness study was not done or at least not described. The submission is for a standalone software module that reconstructs 3D images. It states, "the Fetal Assessment CAP is a simple to use, qualitative 3D ultrasound tool, which provides 3D structures without any measurement functionality." There is no mention of human readers using the system in a comparative effectiveness study.

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

• Yes, a standalone performance assessment was done. The document describes the Fetal Assessment CAP as "proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images" and "can import digital 2D or 3D image file formats for 3D display." The testing focused on whether the software itself satisfied its design intent and conformed to system specifications. The "performance" described is the functionality of the software to process and display images, rather than a diagnostic performance metric.

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

• The term "ground truth" in a medical context (e.g., confirmed diagnosis by pathology) is not applicable here. The software's function is "3 dimensional display" and "reconstruction" of ultrasound images, without measurement functionality. The "ground truth" for this type of device would likely relate to the accuracy and fidelity of the 3D reconstruction based on the input 2D data, and the correct functioning of storage, retrieval, and analysis features. The document states "Test results were reviewed by designated technical professionals," implying validation against the software's specified functional requirements rather than medical ground truth.

8. The sample size for the training set

• This information is not provided. As the device is referred to as "proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images," and not explicitly an AI/ML algorithm (especially given the 1999 date), it's possible there wasn't a "training set" in the modern sense of machine learning. The focus was on software validation.

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

• This information is not provided, and as noted above, a distinct "training set" with established ground truth as understood in current AI/ML might not have been relevant or formalized for this type of software in 1999.

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The Aspen Ultrasound System with the FreeStyle option provides B-mode images of anatomy in a field of view that extends well beyond a conventional B-mode region of interest. The FreeStyle option can also provide qualitative Color flow information in this extended field of view. The indications for use for each transducer operating with the FreeStyle feature are unchanged and include fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, and musculoskeletal uses.

The Aspen Ultrasound System with the FreeStyle feature is a modification of the Aspen Ultrasound System previously cleared as Model 2001, K934915/S1. The FreeStyle feature allows visualization of anatomy over a wider field of view that surrounds a particular region of interest. The feature operates in B-mode and Color Doppler modes for transducers that have been previously cleared by FDA for all indications for use except cardiac, opthalmic, and transcranial uses.

The FreeStyle feature operates by collecting a series of B-mode or Color Doppler image frames in real time, storing them, and then forming a larger composite image for display. The composite image can be displayed within seconds of the real time image frame captures or can be stored and displayed at a later time, perhaps at a Picture Archiving and Communications (PACS) review station. The frames can be captured over a 70cm linear distance or less.

The process is executed by a Pentium II or III based PC running Windows NT that is cabled to the ultrasound system and which resides on a shelf in the ultrasound system console. The hardware and software of the ultrasound system itself has not been modified except to add keyboard strokes the enables the Freestyle option and transfers control between the PC and ultrasound system. The PC has been programmed to store the B mode and Color Doppler image frames captured by the ultrasound system in DICOM format, to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, and to form the composite extended image using a graphics library function, and to transfer the extended image back to the ultrasound system for display or storage.

There is also a caliper measurement capability in the PC software that can be used on the B mode extended images to perform distance and length measurements. The Color Doppler extended images are used to detect the presence or absence of blood flow and are not for quantification.

The provided text is a 510(k) summary for the Acuson Aspen™ Ultrasound System with FreeStyle™ Imaging Option. This document describes the device, its intended use, warnings, and precautions, but it does not contain explicit acceptance criteria or a detailed study section that directly proves the device meets specific performance criteria with reported metrics.

Instead, the document states, "Clinical data was obtained to show the efficacy of FreeStyle images. They are contained in the 510k and were reviewed by FDA." This suggests that a separate document within the 510(k) submission provided the detailed performance data, but this information is not included in the provided text.

Based on the available information, I can only provide general acceptance criteria inferred from the "Warnings and Precautions" and the fact that the device received 510(k) clearance, implying it met the FDA's requirements for substantial equivalence.

Here's an attempt to structure the information, with caveats due to the lack of explicit performance data:

Acceptance Criteria and Device Performance (Inferred)

Since specific numerical acceptance criteria and reported performance metrics are not provided in the summary, the table below is based on the implied performance expectations and warnings outlined in the document. The "Reported Device Performance" column reflects that the device was cleared by the FDA, suggesting these general criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Clinical data was obtained to show the efficacy of FreeStyle images. They are contained in the 510k and were reviewed by FDA."

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the summary. The "Warnings and Precautions" section heavily relies on the "trained sonographer or physician's judgment" for determining image quality and the presence of artifacts, suggesting that clinical expertise is paramount in the operational use of the device.

4. Adjudication Method for the Test Set

The adjudication method is not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not explicitly stated. The document focuses on demonstrating the efficacy of the FreeStyle images themselves rather than comparing performance with and without AI assistance (the FreeStyle option is described as a feature of the ultrasound system, not explicitly as an AI system in the modern sense, though it involves image processing). Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.

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

• Not explicitly stated, but given the nature of the device (an ultrasound system with an imaging option) and the emphasis on user judgment for image interpretation and measurements, it is highly probable that performance was evaluated in the context of human use. The "Warnings and Precautions" explicitly highlight the user's role in assessing image quality and measurement reliability.

7. The Type of Ground Truth Used

The type of ground truth used is not specified in the provided text beyond "Clinical data was obtained to show the efficacy of FreeStyle images." Given the context of a diagnostic ultrasound system, ground truth would typically be established through clinical findings, patient outcomes, or comparison with other established imaging modalities, interpreted by clinicians.

8. The Sample Size for the Training Set

The document does not describe the development or training of an algorithm in the contemporary sense of machine learning, so a "training set" is not applicable in this context. The FreeStyle feature is described as collecting, storing, processing frames "to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, to form the composite extended image," which implies a more classical image processing approach rather than machine learning requiring a training set.

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

As a training set is not applicable (see point 8), this question is not relevant to the provided text.

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The Sequoia™ Ultrasound System in conjunction with the administration of ultrasound contrast agents applies ultrasound energy to an organ, vessel/structure to improve opacification, increase delineation, enhance color Doppler and/or spectral Doppler response, increase visualization of blood flow, document uptake of contrast agent and/or demonstrate perfusion of tissue. The images obtained are useful to physicians in detecting normal and abnormal conditions in regions of the body.
The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The TE-V5M transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 8L5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 6L3 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 15L8 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 8V5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 7V3c transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 5 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction in a The 5 v 2c transducer is intended for flamonio incepts as at they have been approved".
The 3 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction ing the support of the same of of alles indications that they have been approved". The 3V2c transducer is intended for flamont maging and the mave been approved".
The 8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 5C2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 4V2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The EV-8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The Aux CW transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".

The Sequoia™ Ultrasound System with the Harmonic Imaging with Contrast utilizes the previously cleared Sequoia™ Ultrasound system (Acuson Model 3001- K935595/S1) and its transcutaneous as well as invasive transducers to create 2-D, M-mode, color Doppler and Spectral Doppler displays of acoustic data in conjunction with administration of ultrasound contrast agent. There are two primary methods by which images are created. First, the images are created in primary imaging mode, with exactly the same transmit and receive settings and controls as are utilized for routine ultrasound imaging without contrast agent administration. Second, images are created in harmonic imaging mode, with the images created using the same transmit settings and controls as are utilized for routine ultrasound imaging without contrast agent administration but in addition the receive frequency is a multiple of the transmit frequency. In both primary and harmonic imaging, exams can be performed using the standard frame rates applicable during routine ultrasound exams. the number of cycles utilized in routine exams.

The provided document is a 510(k) submission for the Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option. It serves as a regulatory notification of intent to market the device, asserting its substantial equivalence to previously marketed devices. However, it does not explicitly contain acceptance criteria (e.g., performance metrics, thresholds) or detailed study results that "prove the device meets acceptance criteria" in the way a clinical trial report would for a novel device.

The "IMAGING PERFORMANCE" section [2] briefly states: "Clinical studies were conducted to verify the performance of the system in all imaging modes. Clinical data was submitted as part of the Harmonic Imaging with Contrast 510(k)." This indicates that performance verification was done, but the specifics of what was measured, what the acceptance criteria were, and what the results were are not elaborated in the provided text.

Therefore, many of the requested details cannot be extracted from this document.

However, based on the information available, here's what can be provided:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission primarily focuses on demonstrating that the addition of "Harmonic Imaging with Contrast" does not introduce new safety concerns and operates effectively within the existing cleared Sequoia™ Ultrasound system's capabilities.

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 "Clinical studies were conducted to verify the performance of the system in all imaging modes. Clinical data was submitted as part of the Harmonic Imaging with Contrast 510(k)." [2] However, it does not provide details on:

• Sample size used for the test set.
• Data provenance (e.g., country of origin).
• Whether the studies were retrospective or prospective.

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)

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.

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

The document does not describe any adjudication method for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This device is an ultrasound system and its imaging modes, not an AI-assisted diagnostic tool in the contemporary sense.

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

This question is not applicable as the device described is an ultrasound imaging system with new imaging modes, not an algorithm, and it explicitly involves human-in-the-loop operation for image acquisition and interpretation by physicians.

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

The document does not specify the type of ground truth used in the clinical studies. Given the nature of an ultrasound system, it is common for the ground truth to be established by clinical diagnoses, pathology, or comparison with other established imaging modalities, but this is not confirmed in the text.

8. The sample size for the training set

This document describes a medical device (ultrasound system) undergoing 510(k) clearance, which typically does not involve a "training set" in the context of machine learning. The clinical studies mentioned were for verification of system performance. Therefore, a "training set" is not applicable in this context.

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

As there is no "training set" in the context of this device, this question is not applicable.

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