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syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The functionality of the syngo. CT Single Source Dual Energy applications are as follows:

• · Monoenergetic
• · Bone Removal
• · Liver VNC
• · Lung Analysis
• · Gout Evaluation
• · Monoenergetic Plus
• · Virtual Unenhanced
• · Rho/Z
• · Hard Plaques
• · Kidney Stones *

*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

syngo.CT Single Source Dual Energy (twin beam) Software Package is a post processing application package consisting of several post-processing application classes that can be used to improve visualization of various energy dependent materials in the human body. This software application is designed to operate on the most recent version syngo.via client/server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.

After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy (twin beam), a correction algorithm is used in order to minimize motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:

• . Monoenergetic
• Bone Removal ●
• Liver VNC
• Lung Analysis
• Gout Evaluation ●
• Monoenergetic Plus ●
• Virtual Unenhanced .
• Rho/Z ●
• Hard Plaques .
• Kidney Stones .

These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) is optimized correspondingly.

The provided document is a 510(k) premarket notification for a medical device called "syngo.CT Single Source Dual Energy (twin beam)". It describes the device, its intended use, and a comparison with predicate devices. While it mentions "clinical validation" and "performance tests", it does not detail specific acceptance criteria or provide quantitative results in the format of a clinical study or performance study with the level of detail requested in the prompt.

The document states:

• "A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended."
• "Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones."
• "Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes."
• "These studies demonstrate that the subject device using twin beam datasets performs as well as the predicate device applications that were tested using the same methods."
• "The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, accuracy) nor the "reported device performance" (e.g., actual sensitivity, specificity, accuracy values) in a table format. It also does not explicitly state the details requested about sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fully answer the prompt based on the provided text. The document acts as a summary for a 510(k) submission, confirming that studies were performed and found acceptable for substantial equivalence, but it does not present the detailed results expected from an clinical study report.

No information is provided in the document for the following points, so I cannot answer them:

• A table of acceptance criteria and the reported device performance: The document states that "clinical validation" and "performance tests" were conducted and found "acceptable," and that the device "performs as well as the predicate device applications." However, it does not specify the quantitative acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or accuracy) or the actual reported device performance metrics in a table.
• Sample sized used for the test set and the data provenance: No specific sample sizes for test sets are mentioned. The provenance is implied to be "clinical validation" and "retrospective studies," but the country of origin is not specified.
• 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 specified.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
• 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 mentioned. The studies described are for the device's performance, not comparative effectiveness with human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "clinical validation" and "performance tests" for the application, implying standalone performance of the software, but does not explicitly label it as "standalone" or provide specific metrics to differentiate it from assisted performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
• The sample size for the training set: The document discusses performance and clinical validation, but does not describe the training set or its size, or the use of deep learning/AI models that would require a distinct training set.
• How the ground truth for the training set was established: Not applicable, as training set details are not provided.

The only specific information related to "proof" of meeting criteria is:

• "Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) post-processing application."
• "A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended."
• "Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones."
• "Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes."
• "These studies demonstrate that the subject device using twin beam datasets performs as well as the predicate device applications that were tested using the same methods."
• "The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

This indicates that internal studies were performed and deemed sufficient by the manufacturer for the 510(k) submission, confirming the device operates as intended and is comparable to predicate devices. However, the specific quantitative details of these studies are not disclosed in this summary.

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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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The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal. intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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. 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 Ultrsound 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 S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and 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, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System (Acuson S2000™).
It does not contain specific quantitative acceptance criteria or detailed performance metrics from a clinical study for the device itself in terms of sensitivity, specificity, accuracy, etc. Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing technological characteristics and intended uses.

Therefore, a table of acceptance criteria and reported device performance in the typical sense of measuring diagnostic accuracy cannot be constructed from this document. The "performance" demonstrated here is the device's compliance with safety standards and similarity in features/indications for use compared to existing cleared devices.

Acceptance Criteria (Implied by 510(k) Submission):
The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device(s). This is achieved by showing that the device:

• Has the same intended use as the predicate device.
• Has the same technological characteristics as the predicate device OR has different technological characteristics but demonstrates that these differences do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Reported Device Performance (Based on Substantial Equivalence Claim):
The document asserts that:

• The modified Acuson S2000™ Ultrasound System is substantially equivalent to the company's own Acuson Antares and S2000 Ultrasound Systems (Section 3).
• The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards (Section 7).
• Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines (Section 9).
• The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance (Section 9).
• The FDA's review concludes the device is substantially equivalent (page 4, FDA letter).

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

• No specific sample size for a test set is reported. The document explicitly states: "Since the S2000 uses the same technology and principles as existing devices, clinical data is not required." (Section 8). This indicates that no new clinical study (and thus no test set of patients/data) was performed for this 510(k) submission to demonstrate performance in a clinical setting.
• Data Provenance: Not applicable, as no new clinical data was generated or used for a test set. The submission relies on the established safety and effectiveness of the predicate devices.

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

• Not applicable. As no clinical study or test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. As no clinical study or test set requiring ground truth adjudication was performed.

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

• No, an MRMC comparative effectiveness study was not done. The document states that clinical data was not required for this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The Acuson S2000™ is an ultrasound imaging system, not a standalone algorithm. The submission is for the entire device, which would always involve a human operator (the sonographer/clinician).

7. The Type of Ground Truth Used:

• Not applicable for a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices and compliance with recognized safety standards. The new device is deemed safe and effective because it is substantially equivalent to these predicates and meets general safety requirements. The Arterial Health Package (AHP) software, a specific feature, states it provides an option to reference "normative tables that have been validated and published in peer-reviewed studies," implying external, previously established "ground truth" for normative values, not new ground truth generated for this submission.

8. The Sample Size for the Training Set:

• Not applicable. The document describes a traditional medical device submission (an ultrasound system), not an AI/ML-based device that typically involves training sets. The "training" for such a device is likely part of its initial design and engineering, rather than a data-driven algorithmic training set described in this context.

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

• Not applicable. As no training set and corresponding ground truth for an algorithm was used or described in this submission.

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The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following The Modified Beeral Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, apprications: Contral News Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications. The system supports the Superilean Massantanteretalters for Use tables, including the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.

The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.

The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment .
• I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
• AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
• l 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment L
• . EN/IEC 60601-1
• 8 EN/IEC 60601-1-1
• B EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power .
• . ISO 10993-1 Biocompatibility

The provided text describes the Acuson S2000 ABVS Ultrasound System and its 510(k) submission, focusing primarily on its intended use and substantial equivalence to predicate devices, as well as listing safety standards it meets and the transducers supported. However, it does not contain any information regarding specific acceptance criteria, study designs to prove device performance against acceptance criteria, or any performance data (such as accuracy, sensitivity, specificity, or reader studies).

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document states:

• "The S2000 modifications are verified and validated according to the company's design control process." (Section E. Performance Data)

This indicates that internal verification and validation were performed, but the details of these tests, including acceptance criteria and results, are not present in the provided FDA submission summary.

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The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 S2000™ 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 l Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment
• EN/IEC 60601-1
• EN/IEC 60601-1-1
• EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided text describes the Siemens Acuson S2000™ Ultrasound System and its various transducers, outlining their intended uses and compliance with safety standards. However, it does not contain specific acceptance criteria, performance data, or detailed study information such as sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.

The document is a 510(k) summary for premarket notification, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than providing a comprehensive clinical study report with detailed performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about the study design elements as requested, because this information is not present in the provided text. The document states that the device "has been designed to meet" various product safety standards, but it doesn't present performance results against specific criteria.

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The Siemens ACUSON X150 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.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

The provided text is a 510(k) premarket notification for the ACUSON X150 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses common for novel device performance claims.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets them, sample sizes (test or training), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or how ground truth was established for training data.

The document states:

• "The ACUSON X150 modifications are verified and validated according to the company's design control process." (Section 12, E. Performance Data) This is a general statement about their internal quality system processes rather than a summary of specific performance study results.
• The FDA's letter (K081121) confirms substantial equivalence to a predicate device, which inherently means that its performance is considered comparable and acceptable based on existing standards and the predicate's established safety and effectiveness.

The tables provided describe the intended use and available modes of operation for various transducers with the ACUSON X150 system, indicating which applications (e.g., Fetal, Abdominal, Cardiac) and modes (e.g., B-mode, M-mode, Color Doppler) were "previously cleared by K070576" (the predicate device) or are "new indications" (though for this submission, most are "P" indicating previously cleared). This is a functional description, not a performance evaluation against specific metrics.

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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.

Diagnostic imaging or fluid flow analysis of the human body as follows: (followed by tables detailing specific applications and modes of operation for various transducers).

The Siemens ACUSON X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment
• I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• I 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
• 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• . Safety and EMC Requirements for Medical Equipment
  • 트 EN/IEC 60601-1
  • 요 EN/IEC 60601-1-1
  • 트 EN/IEC 60601-1-2
  • 트 EN/EC 60601-1-4
• 이 EN/EC 60601-1-6
• . EN/IEC 60601-2-18
• 피 EN/EC 60601-2-25
• I IEC 61157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided document is a 510(k) summary for the ACUSON X300™ Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies (like test set sample size, provenance, expert qualifications, or adjudication methods), MRMC studies, standalone algorithm performance, or details about the training set.

The "Performance Data" section (Section E) simply states: "The ACUSON X300 modifications are verified and validated according to the company's design control process." This is a general statement and does not provide the specific details requested in your prompt.

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

In summary:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document.
• 2. Sample sized used for the test set and the data provenance: Not provided in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not provided in the document. This is a diagnostic ultrasound system, not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. This is a diagnostic ultrasound system, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
• 8. The sample size for the training set: Not provided in the document. This is a diagnostic ultrasound system, not an AI/ML model that undergoes "training."
• 9. How the ground truth for the training set was established: Not provided in the document.

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Ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal 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 Siemens Sequoia™ Plus 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; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

The provided text is a 510(k) summary for the Siemens Sequoia™ Plus Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "Performance Data" section explicitly states: "The Sequoia™ Plus is designed, verified, and validated according to the company's design control process." This indicates that the validation relied on internal company processes and compliance with general safety and performance standards for diagnostic ultrasound systems, rather than a clinical study evaluating specific diagnostic accuracy against defined acceptance criteria.

The submission focuses on technological equivalence and adherence to established safety and performance standards (like UL, IEC, CSA, AIUM/NEMA, ISO for biocompatibility, and EMC requirements), which are the primary concerns for 510(k) premarket notifications for ultrasound systems like this one.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment from a diagnostic performance study is not present in the provided document.

To answer your request based on the available text:

Acceptance Criteria and Device Performance

This 510(k) summary does not contain specific acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or accuracy) of the ultrasound system for specific clinical applications. The "acceptance criteria" referred to are primarily related to general safety, electromagnetic compatibility, acoustic output, and adherence to established technological standards, rather than direct clinical diagnostic efficacy.

The document indicates "Performance Data" means: "The Sequoia™ Plus is designed, verified, and validated according to the company's design control process." This implies that internal engineering and quality assurance processes were followed to ensure the device performs as intended and meets safety standards.

Table of Acceptance Criteria and Reported Device Performance:

• UL 60601-1 | Device designed to meet
• UL 60601-1 |
  | - IEC 60601-2-37 | - IEC 60601-2-37 |
  | - CSA C22.2 No. 601-1 | - CSA C22.2 No. 601-1 |
  | - AIUM/NEMA UD-3 (Acoustic Output Display) | - AIUM/NEMA UD-3 |
  | - AIUM/NEMA UD-2 (Acoustic Output Measurement) | - AIUM/NEMA UD-2 |
  | - 93/42/EEC Medical Devices Directive | - 93/42/EEC |
  | - EN/IEC 60601-1, 60601-1-1, 60601-1-2 (EMC & Safety) | - EN/IEC 60601-1, 60601-1-1, 60601-1-2 |
  | - IEC 1157 (Acoustic Power Declaration) | - IEC 1157 |
  | - ISO 10993-1 (Biocompatibility) | - ISO 10993-1 |
  | Substantial Equivalence:
• Intended Use | Substantially equivalent to Siemens Acuson Sequoia Ultrasound System (K063085, K051139) with regard to intended use (Cardiac, Neonatal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculoskeletal). |
  | - Technological Characteristics | Substantially equivalent to Siemens Acuson Sequoia Ultrasound System (K063085, K051139) with regard to technological characteristics. |
  | Post-Clearance Acoustic Output (FDA Condition):
• Acoustic output within approved levels | A post-clearance special report containing complete information, including acoustic output measurements based on production line devices, is required to confirm compliance. |

Regarding a diagnostic performance study:

1. Sample size used for the test set and the data provenance: Not applicable. No test set for diagnostic performance is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance is described.
3. Adjudication method for the test set: Not applicable. No test set for diagnostic performance is described.
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 system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
5. 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, and the submission is not for standalone algorithm performance.
6. The type of ground truth used: Not applicable for diagnostic performance. Ground truth for safety and performance standards would be adherence to the specifications of those standards.
7. The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

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The Siemens ultrasound imaging systems are 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 systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The modified software features provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Here's a breakdown of the acceptance criteria and study information based on the provided text for K072090:

Note: The provided text is a 510(k) summary and FDA clearance letter. It is highly limited in the specific details of performance data and study methodologies. Much of the requested information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance details) is NOT present in this document. The document primarily states that testing was done and deemed sufficient for clearance, without providing the raw results or detailed methodology.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or quantitative performance metrics for Auto Ejection Fraction (Auto EF) or Velocity Vector Imaging (VVI). It broadly states that the modifications were "verified and validated according to the company's design control process." This implies that internal acceptance criteria were met, but these criteria and the specific results are not disclosed in this public summary.

Therefore, the table cannot be fully completed from the provided text.

2. Sample Size and Data Provenance

• Sample size for the test set: Not specified in the document.
• Data provenance: Not specified in the document. (e.g., country of origin, retrospective or prospective)

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not specified in the document.
• Qualifications of experts: Not specified in the document.

4. Adjudication Method

• Adjudication method: Not specified in the document.

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

• Was an MRMC study done? Not mentioned in the document. The document focuses on the device performance verification and validation, not a comparative human reader study.
• Effect size of human readers improving with AI vs. without AI: Not applicable, as no MRMC study details are provided.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? The document states "The Auto Ejection Fraction (Auto EF) and Velocity Vector Imaging (VVI) Clinical Applications modifications are verified and validated according to the company's design control process." This generally implies standalone testing of the algorithm's performance against some form of ground truth or benchmark, but no specific metrics or methodology for standalone performance are provided.

7. Type of Ground Truth Used

• Type of ground truth: Not specified in the document. It is implied that some form of "clinical diagnosis purposes" data would be used, but the exact nature (e.g., expert consensus, comparison to a gold standard modality, pathology, outcomes data) is not detailed.

8. Sample Size for the Training Set

• Sample size for the training set: Not specified in the document. This document describes verification and validation of modifications, not the initial development or training process of the algorithms.

9. How Ground Truth for the Training Set Was Established

• How ground truth was established: Not specified in the document, as this document focuses on the verification and validation of modifications and does not delve into the initial training data or its ground truth establishment.

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Diagnostic imaging or fluid flow analysis of the human body as follows: 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 Siemens Acuson X300 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; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/EC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with various transducers. The provided text is a 510(k) Summary and Indications for Use forms, primarily focusing on establishing substantial equivalence to a predicate device and outlining the range of applications for the system and its various transducers. There is no performance data regarding acceptance criteria for an AI/CADe device, and no study is described to prove a device meets acceptance criteria.

The document indicates that "The Acuson X300 modifications are verified and validated according to the company's design control process." However, it does not provide details of specific performance metrics, acceptance criteria, or the study conducted to demonstrate compliance for any AI/CADe functionality. The tables provided are "Indications for Use" forms, not performance tables.

Therefore, for aspects related to AI/CADe acceptance criteria and studies, the requested information is not available in the provided text.

Here's a breakdown of what can be inferred from the text regarding the device and its regulatory submission, but no AI/CADe-specific performance claims or studies are present:

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

This information is Not Available in the provided text for any AI/CADe device. The tables shown are "Indications for Use" forms, indicating the clinical applications and modes of operation for various transducers, not performance metrics or acceptance criteria for an AI/CADe system.

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 Available in the provided text. The submission is for an ultrasound system and its transducers, and no specific test set details for AI/CADe performance are mentioned.

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 Available in the provided text. No ground truth establishment related to AI/CADe performance is described.

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

This information is Not Available in the provided text. No adjudication method related to AI/CADe performance 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

This information is Not Available in the provided text. The submission is for a diagnostic ultrasound system and its transducers, not explicitly for an AI-assisted diagnostic product. There are no mentions of MRMC studies or human reader improvement with AI assistance.

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

This information is Not Available in the provided text. There is no mention of a standalone algorithm performance evaluation.

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

This information is Not Available in the provided text. No ground truth definition related to AI/CADe performance is provided.

8. The sample size for the training set

This information is Not Available in the provided text. No training set details for an AI/CADe system are mentioned.

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

This information is Not Available in the provided text. No ground truth establishment for a training set is described.

Summary of Device and Safety Information (from the provided text):

• Device Name: ACUSON X300™ Diagnostic Ultrasound System / SONOVISTA X300 Diagnostic Ultrasound System
• Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division
• Submission Date: April 11, 2007
• Regulatory Status: Substantially Equivalent to predicate device Siemens Acuson X300 ultrasound system (K061946). This is a 510(k) submission, not a new AI/CADe device seeking market authorization based on clinical performance.
• Intended Use: Diagnostic imaging or fluid flow analysis of the human body for a wide range of clinical 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).
• Transducers covered in this submission (as listed on Page 2 of the FDA letter):
  • P4-2 Phased Sector Array
  • CH5-2 Convex Array
  • VF10-5 Linear Array
  • L9-5 Linear Array
  • EC9-4 Convex Array
  • EV9-4 Convex Array
  • VF13-5 Linear Array
  • P8-4 Phased Array
  • BE9-4 Convex Array
  • CW2 Continuous Wave Doppler
  • CW5 Continuous Wave Doppler
  • Acu Nav 8F Intracardiac
  • Acu Nav 10F Intracardiac
  • V5Ms TEE
  • 4V1c Phased Array
  • VF13-5SP Linear Array
  • C8-5 Tight Curved Array
  • 8L3 Linear "Regel"
  • 10V4 Phased Array Neonatal High Frequency
  • C7F2 Curved Array Mechanical 3D/4D
  • EV9F4 Curved Array Mechanical 3D/4D
  • L13F5 3D/4D Mechanical Wobbler Linear
  • VF8-3 Linear
• Performance Data Mentioned: "The Acuson X300 modifications are verified and validated according to the company's design control process." The FDA letter also requests a post-clearance special report containing acoustic output measurements based on production line devices, referencing "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This indicates a focus on physical and acoustic safety performance standards rather than AI/CADe diagnostic accuracy.
• Safety Standards: The device has been designed to meet several safety standards including UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 61157, and ISO 10993-1.

The provided document describes the regulatory clearance for a diagnostic ultrasound system and its transducers, emphasizing its substantial equivalence to a previously cleared device and adherence to safety standards. It does not contain information about the performance or validation of an AI/CADe component.

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