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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 SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an 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 on a Flat Panel Display.

The provided 510(k) summary for the Siemens SC2000 Ultrasound System focuses on demonstrating substantial equivalence to previously cleared devices rather than outlining detailed acceptance criteria and a specific study proving device performance against those criteria. The submission is for a modification to an existing device (SC2000 Diagnostic Ultrasound System) and a new feature (Clarify VE).

Therefore, this document does not contain the specific information requested about acceptance criteria and a study demonstrating performance against them in the way a submission for a novel AI device might. Instead, it relies on demonstrating that the modified device continues to meet existing safety and performance standards, and that the new feature is substantially equivalent to a feature already cleared on another Siemens device.

However, I can extract information related to the performance data and the comparison to predicate devices, which implicitly serves as the "proof" of meeting acceptance criteria for a substantial equivalence determination.

Here's the breakdown of the requested information based on the provided text, along with notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity targets) for a new algorithm or feature in the way a novel AI medical device submission would. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with established safety and performance standards and showing substantial equivalence to predicate devices.

The "reported device performance" is described qualitatively as meeting these standards and having similar technological characteristics and intended uses as cleared predicates.

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 in the document. The submission focuses on substantial equivalence based on prior clearances and the nature of the modifications (Clarify VE being identical to a previously cleared feature on another system, and the new transducer being similar to existing ones). There is no mention of a specific clinical test set for this 510(k) submission.

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 there is no specific clinical test set described in this 510(k) summary for establishing ground truth for a novel AI algorithm. The device is an ultrasound system with enhanced imaging features, not an AI diagnostic algorithm requiring expert-labeled ground truth for evaluation in this context.

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

This information is not provided for the same reasons as point 3.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study would typically be performed for new AI-powered diagnostic aids, which is not the primary focus of this 510(k) submission (which is for a modification to an existing ultrasound system including a feature like Clarify VE, which enhances image quality rather than providing a direct diagnostic output that would assist human readers in a comparative effectiveness study).

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

This is not applicable and not mentioned. The device described is an ultrasound system, not a standalone algorithm. Clarify VE is an image enhancement feature integrated into the system, not a standalone algorithm output.

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

This information is not provided for a test set, as no specific clinical test set for new feature evaluation is detailed. The "performance data" section focuses on engineering verification and validation against safety and performance standards for the ultrasound system itself, not the clinical accuracy of a diagnostic output.

8. The sample size for the training set

This information is not provided. The document describes an ultrasound imaging system with a new image enhancement feature, not a machine learning model that would have a distinct training set.

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

This information is not provided for the same reasons as point 8.

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V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.

ACUSON Antares Ultrasound System: The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, 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.

ACUSON CV70 Cardiovascular System: The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.

ACUSON Cypress Ultrasound System: The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes

ACUSON S1000/S2000 Ultrasound System: 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."

ACUSON SC2000 Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, 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.

ACUSON Sequoia Ultrasound System: The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON X300 Ultrasound System: 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 measurement of anatomical structures and 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 reqarding 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 V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

Here's a breakdown of the requested information, based on the provided document:

Acceptance Criteria and Study Details for V5Ms Transesophageal Transducer

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission document does not explicitly state quantitative acceptance criteria or specific device performance metrics in the way one might expect for a new or significantly modified device. Instead, the submission relies heavily on substantial equivalence to a previously cleared predicate device (Siemens V5Ms Transesophageal Transducer, K052021). The key "performance data" presented is that "Performance data is not required for this modification as there is no change to software or hardware." This implies that the device is expected to perform identically to its predicate because the changes are limited to patient contact materials.

Therefore, the acceptance criteria are implicitly met by demonstrating that the modifications do not negatively impact the established performance of the predicate device.

Implicit Acceptance Criteria and Reported Performance (Based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable (N/A). The document explicitly states, "Performance data is not required for this modification as there is no change to software or hardware." Therefore, there was no clinical performance test set used. The evaluation centered on non-clinical tests for biocompatibility and asserting substantial equivalence.
• Data Provenance: N/A for clinical performance data. For biocompatibility testing, the data would typically originate from a laboratory (likely in the USA or a facility that adheres to international standards like ISO). The origin is not specified beyond "Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation)."

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

• N/A. As no clinical performance test set was conducted, there was no need for experts to establish ground truth. The primary "experts" involved in the submission would be Siemens' own regulatory and engineering teams, and subsequently, FDA reviewers.

4. Adjudication Method for the Test Set

• N/A. Since no clinical performance test set was conducted, no adjudication method was used.

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

• No. No MRMC study was conducted. The submission is a 510(k) for substantial equivalence based on minor modifications (patient contact materials) to an existing device, not a new clinical effectiveness study.

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

• N/A. The device is a diagnostic ultrasound transducer, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• N/A for clinical effectiveness. For biocompatibility, the "ground truth" is defined by the ISO10993-1 standard for cytotoxicity, sensitization, and irritation. This involves standardized biological tests.

8. The Sample Size for the Training Set

• N/A. This device is a hardware component (transducer) and does not involve machine learning or AI, and therefore does not have a "training set."

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

• N/A. As there is no training set for this device, this question is not applicable.

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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, Vasculoskeletal, 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 S2000™ has been designed to meet the following product safety standards:

• l UL 60601-1, Safety Requirements for Medical Equipment
• l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• li AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• t 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment 트
  • . EN/IEC 60601-1
  • . EN/IEC 60601-1-1
  • I EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power 트
• ISO 10993-1 Biocompatibility l

This 510(k) submission (K093812) for the Siemens Acuson S2000 Ultrasound System describes the device's technical specifications and intended uses, and asserts substantial equivalence to a predicate device. However, it does not contain information regarding a specific clinical study with acceptance criteria and device performance metrics, as would be expected for a novel AI-powered diagnostic device.

The document primarily focuses on:

• Device Description: Listing safety standards the system meets (e.g., UL 60601-1, IEC 60601-2-37).
• Intended Use: Broad applications for ultrasound imaging across various anatomical regions and patient populations.
• Transducer Information: Detailed tables indicating the modes of operation (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging) and additional features (e.g., tissue harmonic imaging, spatial compounding) cleared for each specific transducer.
• Predicate Device: Stating the Acuson S2000 is substantially equivalent to the Acuson Antares Ultrasound System.

The "Arterial Health Package (AHP) software," which provides "capability to measure Intima Media Thickness and the option to reference normative tables," mentions that these tables "have been validated and published in peer-reviewed studies." However, it does not provide details of an internal study conducted by Siemens to prove that their device's AHP functionality meets specific acceptance criteria based on these peer-reviewed studies.

Therefore, I cannot populate the requested tables and information as a study proving device performance against acceptance criteria is not present in the provided text. The document is a regulatory submission for device clearance based on substantial equivalence, rather than a detailed report of a performance study.

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The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} 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 Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen 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 Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

• Device Description: General features and function of the ultrasound system and its accessories.
• Intended Uses: A broad list of clinical applications for the system and various transducers.
• Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
• Safety Considerations: Compliance with general safety standards and acoustic output limits.
• Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.

The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.

The 7340 and 6150 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided 510(k) summary for the Esaote 7340 & 6150 Systems is a premarket notification for new features added to previously cleared ultrasound imaging systems. It does not contain information about an in-depth study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, the requested information elements related to detailed study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for meeting acceptance criteria (as typically expressed for new performance claims) are not present in this type of submission. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the identified predicate devices for the new features (Elastography and 3D/4D in specific applications).

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and noting where it is not applicable for this type of submission:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this 510(k) are demonstrating substantial equivalence. The device performance is implicitly considered equivalent to the predicate devices for the functionalities being added.

Study Information (Based on the provided Summary)

This document is a 510(k) summary, not a full study report. It focuses on demonstrating equivalence rather than presenting a performance study with acceptance criteria.

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

   • Not provided. This type of detail is not typically included in a 510(k) summary for a substantial equivalence claim based on predicate device features. It's implied that the predicate devices themselves underwent such testing. The current submission is more focused on the technical design equivalence of the new features.

2. 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 provided. Ground truth establishment, if any for specific performance testing, would have been part of the predicate device clearances or internal testing not detailed in this summary.

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

   • Not provided. As a substantial equivalence claim, a formal adjudication process for a test set is not 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 document describes features of an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm or a comparative effectiveness study with human readers. The "AI" implied might be the "Elastography (ElaXto) analysis" and "3D/4D modality", but these are presented as imaging modes, not decision-support AI.

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

   • Not applicable. This is an ultrasound imaging system rather than a standalone algorithm with a distinct performance evaluation. The added features are integral to the imaging process.

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

   • Not provided. For a substantial equivalence claim regarding new imaging features like elastography and 3D/4D, technical specifications, image quality assessments, and possibly phantom studies are typically used to demonstrate equivalence rather than clinical ground truth from patient outcomes or pathology, unless explicit new clinical claims are being made.

7. The sample size for the training set:

   • Not applicable / Not provided. These are ultrasound imaging systems with added features, not machine learning algorithms that typically require a distinct training set. The "training" in this context would likely refer to the general development and calibration process of imaging technologies, not a labeled dataset for AI.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As above, the concept of a "training set" and associated ground truth in the context of an AI/ML device is not directly relevant to this type of ultrasound system 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 Imagino".

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 Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUMNEMA 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 Acuson S2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the intended uses and safety standards. It does not contain information about acceptance criteria for specific device performance metrics, nor does it describe a study proving the device meets particular performance acceptance criteria.

The document lists:

• Safety standards the device has been designed to meet (e.g., UL 60601-1, IEC 60601-2-37). These are general design and manufacturing standards, not specific performance acceptance criteria for clinical efficacy or accuracy.
• Intended Use for various clinical applications and the ability to measure anatomical structures.
• Predicate Device: Acuson Antares Ultrasound System. This indicates that the new device is compared to an existing one for substantial equivalence, but the details of that comparison or specific performance outcomes are not within this summary.
• List of Transducers and their cleared clinical applications and modes of operation.

Therefore, requested information regarding specific acceptance criteria, device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone performance studies cannot be extracted from this document. The document's purpose is to state intended use and demonstrate compliance with general safety and regulatory standards through substantial equivalence to a predicate device, rather than to detail performance studies against numerical acceptance criteria.

In summary, none of the specific information requested about acceptance criteria and a study proving their fulfillment is present in the provided document.

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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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.

The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and receive ultrasound energy.

The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.

The provided document is a 510(k) premarket notification for the ZONARE z.one Ultra Ultrasound System. This type of submission is for demonstrating substantial equivalence to legally marketed predicate devices, not for proving the device meets acceptance criteria through clinical studies in the same way a new, high-risk device might.

The document explicitly states: "Clinical Tests: Non Required" and then elaborates: "ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that the ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market."

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted from this document, as such studies were not required for this type of submission. The "acceptance criteria" here largely refer to the device's ability to perform its intended functions similarly to predicate devices and adherence to safety standards.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since formal clinical studies with specific performance metrics are not required and therefore not reported in this 510(k), I can only infer the "acceptance criteria" as meeting the general capabilities and safety standards demonstrated by predicate devices.

Each table indicates whether an application is a "P" (previously cleared by FDA 510k # 022858, implying equivalence to the existing ZONARE z.one) or "N" (new indication). For "P" indications, the device is considered to perform equivalently to the predicate. For "N" indications, the device is being introduced for those uses, likely based on similarity to other cleared devices or demonstrating safety and basic functionality in non-clinical tests.

Examples of supported modes for various transducers include:

• B¹ (B-Mode and Harmonic Imaging): P (Previously cleared) or E (Added under Appendix E) or N (New indication) across most applications.
• M (M-Mode): P or E or N across most applications.
• PWD² (Pulsed Wave Doppler and HPRF): P or E or N across most applications.
• CWD (Continuous Wave Doppler): P or N for specific applications (e.g., Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult & Pediatric, Peripheral Vascular for the main system, and specific entries for some transducers).
• Color Doppler³ (Color Doppler, Directional Power Doppler, Power Doppler): P or E or N across most applications.
• Combined Modes⁴: P or E or N across most applications.
• Other⁵,⁸ (e.g., Color M-Mode, Freehand tissue elasticity): P or E or N for relevant applications.

The presence of "P" or "E" in these tables fundamentally means that for those indications and modes, the ZONARE z.one Ultra performs equivalently to the already cleared ZONARE z.one (K022858) or other cleared predicate devices. The "N" indications represent new proposed uses for the system or specific transducers, which are deemed safe and effective through substantial equivalence to other devices or non-clinical testing. |
| Safety and Effectiveness Standard Adherence: The device must conform to applicable medical device safety standards. | "The device has been evaluated according to the applicable medical device safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety."
"The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance."
"ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems." |
| Predicate Device Features Equivalence: The device must have the same important safety and effectiveness features, design, materials, and construction as predicate devices. | "Additionally, they [ZONARE z.one Ultra and predicate devices] have the same important safety and effectiveness features, as well as design, materials, and construction." |

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

• Sample Size for Test Set: Not applicable. No clinical test set (in the sense of patient data for performance evaluation) was specified as "Clinical Tests: Non Required."
• Data Provenance: Not applicable. No clinical data was used for a test set. The validation relies on substantial equivalence and adherence to safety standards.

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

• Not applicable, as no clinical 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 test set requiring adjudication was performed.

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

• Not applicable. This document is for a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was conducted or required.

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

• Not applicable. This is not an algorithmic/AI device; it's a hardware system.

7. The Type of Ground Truth Used

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's safety and effectiveness is established by its substantial equivalence to legally marketed predicate devices and its compliance with recognized medical device safety standards. This is not a "ground truth" in the clinical data sense (e.g., pathology, outcomes data). The existing ZONARE z.one (K022858), GE Voluson i (K053435), Philips iU22 (K042540), and Siemens Acuson S2000 (K072786) served as predicates.

8. The Sample Size for the Training Set

• Not applicable. The device is a diagnostic ultrasound system, not an AI/machine learning model that typically undergoes a "training" phase with a dataset.

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

• Not applicable for the same reason as above.

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