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ACUSON Sequoia and Sequoia Select

The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Origin and Origin ICE

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures). Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text, specifically for the expansion of the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to pediatrics:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of individual patients: 105 patients.
  • 40 patients scanned with the DAX transducer.
  • 27 patients with the 5C1 transducer.
  • 38 patients with the 9C2 transducer.
• Number of samples: 525 measurements (Five UDFF measurements were obtained per patient).
• Data Provenance: Data were collected from two institutions in the US and France. The studies tested UDFF in children during clinically indicated MRI procedures.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). It only states that "MRI PDFF was used as the reference standard." The interpretation and establishment of ground truth from MRI-PDFF would typically involve qualified medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The reference standard used was MRI-PDFF, which is a quantitative measure and therefore may not have required such an adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with and without AI assistance was not reported. The study focused on the performance of the UDFF tool itself against a reference standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the testing described appears to be for the standalone performance of the UDFF algorithm. The criteria and results focus on the measurements generated by the UDFF tool (AUROC, ICC, exam time) in comparison to the MRI-PDFF reference standard. While the tool is intended to "aid a physician," the performance metrics presented demonstrate the algorithm's capability independent of direct human interaction in the evaluation setup.

7. The Type of Ground Truth Used

The ground truth used was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). Steatosis was defined as MRI-PDFF greater than 5%.

8. The Sample Size for the Training Set

The document explicitly states that the UDFF algorithm remained unchanged and was not retrained for these studies. Therefore, no specific training set sample size for this expansion is provided, as the existing algorithm developed for adults was applied to the pediatric population.

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

Since the UDFF algorithm was not retrained and remained unchanged, the document does not describe how the ground truth for its original training set was established. It only clarifies that the data from these pediatric studies were considered "test data to evaluate the performance of UDFF in children using MRI PDFF."

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ACUSON P500 Ultrasound System
The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

ACUSON P500 ICE Ultrasound System
The ACUSON P500 ICE ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

The ACUSON P500 and P500 ICE Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

The provided text is an FDA 510(k) clearance letter for the ACUSON P500 and P500 ICE Ultrasound Systems. It does not contain the specific details of acceptance criteria or a study proving the device meets those criteria. The document explicitly states:

"Since the ACUSON P500 and P500 ICE Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

This means that a specific clinical study with acceptance criteria, test sets, expert ground truth, etc., as requested in your prompt, was not performed or submitted for this particular clearance, as the device was deemed substantially equivalent to a previously cleared predicate device.

Therefore, I cannot provide the requested information from the given text.

If you have a document that describes the specific acceptance criteria and a study that proves the device meets them, please provide that document.

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The ACUSON SC2000 Diagnostic Ultrasound System is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with proprietary software and accessories. The function of the ACUSON SC2000 Diagnostic Ultrasound System is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, measurements, calculations, analysis of the human body and fluid flow, etc.

The provided document is a 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states that no clinical data was required or conducted to support substantial equivalence for this device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth details, as these clinical study elements were not performed.

The document focuses on non-clinical data to demonstrate safety and performance, primarily through compliance with voluntary standards and compatibility testing with existing catheters.

Here's a breakdown of what can be extracted from the document regarding the device's validation:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable as no clinical study with explicit acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) was conducted or reported in this 510(k) summary. The document focuses on showing compliance with performance standards for ultrasound systems generally and compatibility with specific catheters.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from patients was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.

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 is an ultrasound system and there is no mention of AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm-only device. Performance evaluations focused on the system's ability to generate ultrasound images and facilitate measurements, as well as its compatibility with certain catheters.

7. The type of ground truth used: Not applicable. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) was used as no clinical study was conducted.

8. The sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm, but rather the clearance of an ultrasound system.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device Validation based on the Provided Text:

The ACUSON SC2000 Diagnostic Ultrasound System's substantial equivalence to its predicate device (ACUSON SC2000 Diagnostic Ultrasound System v6.1 (VC11) K211726) is supported by non-clinical data.

• Rationale for No Clinical Data: "The proposed ACUSON SC2000 Diagnostic Ultrasound System did not require clinical studies to support substantial equivalence." (Page 9)
• Non-clinical Data Focus: The submission primarily demonstrates that:
  • The device complies with various voluntary standards related to medical electrical equipment, ultrasound field characterization, biological evaluation of medical devices, usability, risk management, software lifecycle process, and quality management systems (listed on pages 8-9).
  • The ACUSON SC2000 Diagnostic Ultrasound System v6.5 (VC15) is compatible with the AcuNav Crystal Ultrasound Catheter (K233270) and SoundStar Crystal Ultrasound Catheter (K240050), and the SwiftLink Plus Connector. This compatibility testing demonstrates that the system performs as intended with these accessory devices.
• Conclusion: "The non-clinical testing data support the safety of the device and demonstrate that the ACUSON SC2000 Diagnostic Ultrasound System is compatible with the AcuNav Crystal Ultrasound Catheter and the SoundStar Crystal Ultrasound Catheter and the system performs as intended in the specified use conditions. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 Diagnostic Ultrasound Systems are as safe and effective with substantially equivalent performance as the predicate device." (Page 9)

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The SOUNDSTAR™ CRYSTAL Ultrasound Catheter and related accessory devices are indicated 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. When used with compatible CARTO™ 3 EP Navigation Systems, the catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.

The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.

The provided text is a 510(k) premarket notification for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. It does not describe a study involving acceptance criteria and device performance in the context of AI/algorithm performance.

The document states: "The SOUNDSTAR™ CRYSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence." This indicates that the regulatory submission primarily relies on demonstrating equivalence to a previously cleared device through non-clinical testing, rather than presenting a study proving performance against specific acceptance criteria with human or AI assessment.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (especially a clinical or AI-centric one) is not included in this submission. The "Performance Testing" section lists various engineering and safety standards (e.g., ISO, ANSI/AAMI, IEC) that the device complies with, but these are not presented as acceptance criteria for performance in the way described in your prompt (e.g., sensitivity, specificity, or human reader improvement with AI).

If you have a different document that details a clinical study or AI algorithm performance, I would be happy to analyze that.

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