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The 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 of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The AcuNav V ultrasound catheter is sterile, 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 provided text is a 510(k) summary for the AcuNav V 10F Diagnostic Ultrasound Catheter. It discusses the device's indications for use, substantial equivalence to a predicate device, and nonclinical tests. However, it explicitly states that clinical data is not required to establish substantial equivalence because the submitted device uses the same technology, patient contact materials, and principles as the predicate device.

Therefore, many of the requested details regarding acceptance criteria and studies (especially those related to clinical performance, effectiveness, or comparative studies with human readers) are not available in this document.

Here's a breakdown of the information that can be extracted and what is not provided based on your request:

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

The document does not explicitly present a table of acceptance criteria for clinical performance or reported device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and safety standards.

The closest equivalent to "acceptance criteria" here relates to adherence to safety standards and equivalence to the predicate:

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

This information is not provided as no clinical test set or data provenance from a clinical study is described. The device's substantial equivalence was established without clinical data.

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)

This information is not provided as no test set requiring expert ground truth or clinical evaluation was conducted.

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

This information is not provided as no clinical test set requiring adjudication was conducted.

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

An MRMC comparative effectiveness study was not done. The document states that clinical data is not required because the device relies on existing technology and principles. This device is a diagnostic ultrasound catheter, not an AI-assisted diagnostic tool.

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

A standalone performance study was not done in the context of diagnostic accuracy. The "standalone performance" was assessed in terms of adherence to safety and performance standards for the device itself (acoustic output, biocompatibility, etc.), not as an AI algorithm.

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

This information is not provided as no clinical study requiring a diagnostic ground truth was conducted. For the non-clinical tests, the "ground truth" was the specifications and requirements of the safety standards (e.g., ISO 10993-1 for biocompatibility).

8. The sample size for the training set

This information is not provided as no training set for a diagnostic algorithm was used.

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

This information is not provided as no training set for a diagnostic algorithm was used.

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The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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 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 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. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav and Soundstar Ultrsound Catheter are 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 of adult and pediatric patients.

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, 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 typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications. The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal 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 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging.

Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the request details:

Acceptance Criteria and Device Performance

The document describes the Siemens SC2000/X300 Diagnostic Ultrasound System and its various transducers. The acceptance criteria essentially focus on demonstrating substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices and meets safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Since the modified devices use the same technology and principles as existing devices, clinical data is not required." This indicates that no clinical test set with human patients was used specifically for this 510(k) submission. The evaluation was based on nonclinical tests and comparison to predicate devices. Therefore, there is no sample size, country of origin, or information on retrospective/prospective data for a clinical test set.

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

As there was no clinical test set for this 510(k) submission, there is no mention of experts used to establish ground truth for a test set. The review focused on engineering and performance standards, and comparison to previously cleared devices.

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

Not applicable, as no clinical test set was used.

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. The document describes a diagnostic ultrasound system and its transducers, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

Not applicable. This device is a diagnostic ultrasound system, not a standalone algorithm.

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

For the nonclinical tests conducted, the "ground truth" would be established by the specifications and performance metrics outlined in the various referenced safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, etc.). For the substantial equivalence claim, the ground truth is the performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as this is a traditional diagnostic ultrasound system, not an AI/ML-based device requiring a training set.

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

Not applicable, as no training set was used.

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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, 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 typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The Acuson SC2000™ has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; Safety and EMC Requirements for Medical Equipment; IEC 60601-1; IEC 60601-1-1; IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

This 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System is a Special 510(k), indicating a minor change to a previously cleared device. Therefore, a comprehensive de novo clinical study demonstrating performance against acceptance criteria for a novel device is not part of this submission. Instead, the performance data section explicitly states: "No performance data required to support this modification, as there is no change to any hardware or software, or method of use."

The submission focuses on demonstrating substantial equivalence to a previously cleared device (K123622) by only renaming three transducers. As such, the typical elements of a study proving a device meets acceptance criteria (like a test set, ground truth, experts, and statistical results) are not provided in this document.

However, I can extract the acceptance criteria implied by this type of submission, which is the determination of substantial equivalence to the predicate device for the specified indications for use.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for a Special 510(k) for Renaming Transducers): The modified device, specifically the renamed transducers, must demonstrate substantial equivalence to the previously cleared predicate device concerning intended use and technological characteristics, with no changes to hardware, software, or method of use.

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

• Sample Size for Test Set: Not applicable. No new performance testing with a specific test set was conducted for this Special 510(k) given the nature of the modification (renaming transducers).
• Data Provenance: Not applicable. No new data was generated or analyzed for this submission. The basis for substantial equivalence relies on the established performance of the predicate device and the claim that the changes are confined to nomenclature.

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

• Number of Experts: Not applicable. No new ground truth establishment was required as no new performance data was generated.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This submission does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is an ultrasound imaging system, not an AI algorithm requiring standalone performance evaluation in the context of this submission.
• The document states there is "no change to any hardware or software," implying no new algorithms or software features are being introduced that would require such testing.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for new performance evaluation. The "ground truth" for this Special 510(k) is implicitly the established safety and effectiveness of the predicate device (K123622), to which the modified device (with renamed transducers) is claimed to be substantially equivalent without any functional changes.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of any new algorithms or software components.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intrcperative Neurological, 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 typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for themical indices related to potential bio-effect mechanisms. Its function is to acquire primary of Secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Dopler Mode, a combination Continuous (CW) Doppler Mode, Color Dopen Mode, Ampling on a France, Nissalay of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000™Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat P available off-line workstation (SC2000WP).

Here's an analysis of the provided 510(k) summary regarding the Acuson SC2000™ Diagnostic Ultrasound System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics in the way a clinical trial for a new therapeutic device might. The "performance data" section in this type of submission generally refers to engineering verification and validation against internal specifications and relevant safety standards, rather than direct clinical performance in terms of diagnostic accuracy against a ground truth in a clinical setting.

Therefore, the answers below will reflect the information available in this type of regulatory document. Many of the requested details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, effect size, and training set information) are explicitly not present in a standard 510(k) premarket notification for an ultrasound system, as this is a device modification submission focusing on safety and technological equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily based on established safety and performance standards for diagnostic ultrasound systems, and the "reported device performance" is the device's demonstrated compliance with these standards and verification of its specifications.

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

The document does not specify a "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy). The performance data cited refers to engineering and safety testing. Therefore, there is no information provided regarding sample size for a clinical test set or data provenance (e.g., country of origin, retrospective/prospective clinical data).

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

Not applicable/Not provided. As stated above, this submission focuses on technical safety and performance validation against standards, not a clinical study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set or adjudication method is mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. The document does not mention any MRMC comparative effectiveness study, nor does it provide information on a human readers' improvement with or without AI assistance. This type of study is not common for 510(k) submissions of basic ultrasound system modifications.

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

No. The SC2000™ is a diagnostic ultrasound system, an imaging device operated by a human. It is not an AI algorithm intended for standalone diagnostic performance. The document describes the system's ability to acquire and display ultrasound data, and its "calculation packages" provide information to the clinician for diagnosis, implying human interpretation is always in the loop.

7. The Type of Ground Truth Used

For the safety and performance testing described, the "ground truth" is defined by the technical specifications for the device and the objective criteria outlined in the various international and national safety and performance standards (e.g., acoustic output measurements, electrical safety limits, biocompatibility standards). This is engineering and regulatory compliance ground truth, not clinical ground truth (like pathology results or patient outcomes) for diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable/Not provided. This submission describes an ultrasound imaging system, not a machine learning model that requires a training set.

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

Not applicable/Not provided. As there is no mention of a machine learning model or training set, the establishment of ground truth for such a set is not relevant to this submission.

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