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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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