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The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.

The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The intended use of the Affiniti Series Diagnostic Ultrasound Systems is ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the following two new Liver Fat Quantification software features:

• (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver
• (2) Hepato-Renal Index Quantification: a ratio measure of the echogenicity ('brightness') of the liver parenchyma relative to that of the adjacent renal cortex

The features provide the end user with the capability to calculate attenuation of the liver and an hepato-renal index ratio during an ultrasound exam using Philips EPIQ or Affiniti Ultrasound System. Previously cleared liver quantification tools available to the end user include Shear Wave Point Quantification (ElastPQ, cleared via K17207 on 04 Oct 2017) and Shear Wave Imaging (ElastQ, cleared via K181485 on 27 Jul 2018). These existing quantification features measure liver stiffness on real-time and retrospective images.

The provided text describes specific features related to liver fat quantification (Attenuation Quantification and Hepato-Renal Index Quantification) for Philips Ultrasound systems. However, it does not contain detailed information about acceptance criteria, the specific study that proves the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) comparative effectiveness studies.

The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and general design control activities. It mentions "Software Verification and Validation testing" and "Non-clinical bench performance testing" but does not provide the results of these tests in a detailed, quantitative manner against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document confirms the device's intended use and regulatory classification but lacks the specifics of performance studies that would typically include acceptance criteria and detailed study results.

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The ACUSON Sequoia 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, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, 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.

The SC2000 ultrasound imaging system is intended 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 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 Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), 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, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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. 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 Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) 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 P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) 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 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."

The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients.

For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology 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.

For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology 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 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.

Note: 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 Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system 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, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.

Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.

The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.

The provided document is a 510(k) Pre-market Notification for several Siemens ACUSON Diagnostic Ultrasound Systems, seeking clearance based on substantial equivalence to previously marketed devices. The document explicitly states that no new features, modifications, or changes were made to the hardware or software of the devices themselves. The entire submission focuses on an "expanded labeling" for lung ultrasound imaging, supported by existing clinical literature.

Therefore, the acceptance criteria and the study proving the device meets these criteria are not related to a new device or a new AI/algorithm feature being validated. Instead, it is about demonstrating that the existing, cleared devices can be marketed with expanded indications for use, supported by references to previously conducted tests and existing clinical literature.

Given this, I cannot provide information on:

• Reported device performance (as no new performance was claimed or tested)
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Sample size for training set or how ground truth for training set was established

The document explicitly states: "clinical studies were not required to support substantial equivalence. The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature." and "There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission."

Below is a table summarizing the acceptance criteria and "device performance" in the context of this 510(k) submission, emphasizing that the "performance" here refers to the device meeting the previously established safety and effectiveness for its predicate indications, which is being extended to a new recognized clinical use case via labeling.

Description of Acceptance Criteria and Evidence for ACUSON Diagnostic Ultrasound Systems (K202683)

This 510(k) submission (K202683) by Siemens Medical Solutions, USA, Inc., is a Special 510(k). This type of submission is used when changes to a cleared device do not alter its fundamental scientific technology or intended use, but may expand its labeling or functionality within its established safety and effectiveness profile. In this specific case, the submission focuses on expanded labeling for Lung Ultrasound Imaging (LUS), utilizing the existing capabilities of the cleared ACUSON Diagnostic Ultrasound Systems and their associated transducers.

Crucially, the document states that no modifications were made to the software or hardware of the devices. Therefore, the "acceptance criteria" and "proof" are based on demonstrating substantial equivalence to previously cleared predicate devices and leveraging existing validation data for those predicates, rather than presenting new performance metrics for a novel algorithm or device.

1. Acceptance Criteria and Reported Device "Performance" (Meeting Substantial Equivalence)

Detailed comparison tables (Table 2 in the original document, not fully reproduced here due to length) consistently list "Identical" for all compared technological characteristics: Reusability, Duration of Use, Scientific Technology, Operating Principles, Type of Previously Cleared Transducers, Acoustic Outputs, Previously Cleared Imaging Modes, and Biocompatibility (ISO 10993-1). |
| Safety and Effectiveness: There are no new safety or effectiveness concerns introduced by the expanded labeling. | - Software Verification and Validation: The CRS (Customer Requirement Specifications) for each device were verified/validated during original development. No software/hardware modifications for this submission.

• Standards Compliance: Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1 - 3.20 (DICOM).
• Risk Management: Risk analysis (ISO 14971:2007) was performed on predicate devices, and mitigation controls were implemented. The expanded labeling does not impact these.
• Cybersecurity: Cybersecurity measures are addressed and conform to requirements to prevent unauthorized access, modification, misuse, or denial of use.
• Clinical Literature Support: The expanded labeling for Lung Ultrasound Imaging (LUS) is supported by clinical literature, indicating that the use of ultrasound for lung imaging is an established and safe practice. Clinical studies were not required for this 510(k) as the technology and operating principles are unchanged. |

2. Sample Size and Data Provenance for Test Set

• Test Set Description: Not applicable. For this Special 510(k), no new test set data for device performance was generated or presented. The submission relies on existing validation data for the predicate devices.
• Data Provenance: The underlying data for previously cleared predicate devices would have been generated through rigorous internal testing and validation processes during their initial development and clearance. The document implies that this data exists and supports the current device. The document explicitly states: "Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission."

3. Number, Qualifications, and Adjudication Method for Experts

• No new expert assessment: Not applicable for this Special 510(k). Since no new AI/algorithm features or changes to device performance were introduced, there was no independent expert review of a new test set for the purpose of this submission. The "ground truth" for the expanded labeling (Lung Ultrasound) is based on established clinical recognition and existing peer-reviewed literature.
• Adjudication method: Not applicable.

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

• No new MRMC study: Not applicable. This submission does not involve a new AI or algorithm that would require an MRMC study to demonstrate human improvement with AI assistance.

5. Standalone (Algorithm Only) Performance Study

• No standalone algorithm: Not applicable. The submission is for diagnostic ultrasound systems, not a standalone algorithm. The core functionality is the ultrasound imaging, and the "expansion" is in the labeling for an existing modality.

6. Type of Ground Truth Used for Device Functions

• Existing Validated Performance: For the predicate devices, the ground truth and validation would have been established through a combination of:
  • Direct measurement and engineering specifications: For image quality, acoustic output, and system performance.
  • Clinical validation: Through various means including phantom studies, retrospective/prospective clinical data, and expert consensus for the initial indications.
• Clinical Literature/Consensus for Expanded Indication: For the new labeling related to Lung Ultrasound Imaging (LUS), the "ground truth" or justification is based on:
  • Established clinical practice: Recognition within the medical community for the utility of ultrasound in lung assessment.
  • Peer-reviewed studies and professional guidelines: As explicitly stated, the LUS labeling is "supported by clinical literature." This effectively implies that the medical community's consensus on the utility of LUS (as documented in such literature) serves as the "ground truth" for its clinical relevance.

7. Sample Size for Training Set

• No new training set: Not applicable. As no new AI/algorithm components were introduced or modified, there was no "training set" for the purpose of this specific 510(k) submission.

8. How Ground Truth for Training Set was Established

• No new training set: Not applicable.

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The 3D Auto LAA is a software application designed to view and quantify 3D image data acquired by Philips Ultrasound Systems for use in measuring the area, circumference, and diameter of a Left Atrial Appendage (LAA) orifice.

The purpose of this Traditional 510(k) Pre-market Notification is to introduce the new 3D Auto LAA cardiac quantification application for use on the Philips EPIQ and Affiniti Diagnostic Ultrasound systems, which were most recently cleared under K201012. The 3D Auto LAA application is compatible with 3D images generated via Philips Transesophageal Echocardiogram (TEE) transducers such as the X8-2t and X7-2t. The Philips 3D Auto LAA cardiac quantification application is a semi-automated application intended to provide measurements of the Left Atrial Appendage. The 3D Auto LAA application is designed to provide automatic and editable area, circumference, and diameter measurements of the Left Atrial Appendage (LAA) orifice. When the 3D Auto LAA application is launched, going through the workflow provides the clinician with a semi-automated preliminary border of the LAA in three planes based on greyscale intensity differentiation with some shape regularization.

Here's a breakdown of the acceptance criteria and the study information for the Philips 3D Auto LAA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria with numerical targets (e.g., accuracy > 90%) or directly reported performance metrics tied to such criteria. Instead, it states that the device was tested to "meet the defined requirements and performance claims." The "performance claims" are implicitly about the functionality of providing semi-automated measurements of LAA area, circumference, and diameter.

Here's an interpretation based on the document's content, focusing on the functionality described:

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device by comparing intended use and technological characteristics, and by conducting internal V&V testing. It does not provide a detailed performance study with quantitative results against specific, pre-defined acceptance metrics.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "Performance Validation Study" or any other non-clinical V&V testing. It only mentions that testing was performed.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a non-clinical performance validation study and not a clinical trial, it's likely internal engineering data or synthetic data, but this is not explicitly stated.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the non-clinical test set. As this was a "Performance Validation Study" for a software application for quantification, it's more likely that the "ground truth" was derived from predefined technical specifications, comparison to manual measurements by engineers, or comparison to the predicate device's output, rather than expert clinical consensus on images.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and The Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The document explicitly states: "The subject Philips 3D Auto LAA cardiac quantification did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s)." This indicates no human-in-the-loop performance study for regulatory submission purposes.

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

Yes, a standalone performance assessment was done implicitly. The "Performance Validation Study" and "Software Verification and Validation testing" address the algorithm's performance in generating semi-automated borders and measurements. However, it's important to note the device is described as "semi-automated," implying a human-in-the-loop is part of the intended use (to refine the borders). The testing reported here focuses on the algorithm's capability to generate these preliminary borders and measurements.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the non-clinical V&V testing. Given the nature of a software quantification tool, it's highly probable the ground truth involved:

• Comparison against measurements obtained manually by trained individuals (engineers or potentially clinicians) using existing validated methods.
• Comparison against the performance of the predicate device (QLAB System's 3DQ Q-App) manual tracing options, to ensure equivalence.
• Internal gold standards derived from expert-generated manual segmentations on a subset of images used for development and testing.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This information is typically not included in a 510(k) summary focused on substantial equivalence and non-clinical testing.

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

The document does not provide any information on how the ground truth for the training set was established.

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