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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 AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use.

The AIDA diagnostic ultrasound system is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time B-mode imaging. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) Premarket Notification for the AIDA Diagnostic Ultrasound System GM-72P00A. It primarily focuses on:

• Administrative Information: Submitter's name, address, contact, date, trade name, model, common name, classification, and regulatory class.
• Device Description: What the device is (portable ultrasound system optimized for peripheral vessels, automated IMT measurement, plaque search, cardiovascular risk assessment).
• Standards Compliance: List of various UL, IEC, ISO, and NEMA standards the device is designed to comply with.
• Intended Use: Specifically for Peripheral Vessel applications, automated IMT measurement of peripheral vessels (like common carotids) in BIMT mode, heart rate range 20-150 bpm, and contraindication for fetal use.
• Technological Comparison to Predicate Device: States substantial equivalence to previously cleared devices (K093171, K081794, K022567) based on transmitting ultrasonic energy, post-processing echoes for display, and specialized measurement capabilities.
• FDA Correspondence: Letter from FDA confirming substantial equivalence and providing guidance.
• Indications for Use Statement: Reiterates the intended use for peripheral vessels, BIMT mode, and heart rate range.
• Clinical Application Table for Transducer L13-5V1: Specifies the clinical applications for the L13-5V1 transducer, noting "Peripheral vessel" as a new indication (N) using Combined mode B + IMT.

Therefore, I cannot provide the requested information in a table or answer the specific questions about the study, sample sizes, ground truth, or MRMC study, as this data is not present in the provided text.

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The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penrith Elettra Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K100598) is a premarket notification for a diagnostic ultrasound system. For this type of device, the primary "acceptance criteria" for clearance through the 510(k) pathway is demonstrating substantial equivalence to a predicate device. This means the device is as safe and effective as a legally marketed device.

Therefore, the acceptance criteria are implicit:

• The device must perform in a manner substantially equivalent to predicate devices.
• The device must meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning, disinfection, sterilization, thermal, electrical, mechanical safety, and electromagnetic compatibility.
• All claimed indications for use must be covered by the predicate devices.

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

This document describes a 510(k) premarket notification for an ultrasound system, which primarily relies on demonstrating substantial equivalence to predicate devices, rather than a clinical study comparing the device to a "gold standard" or a control group.

• No specific "test set" sample size is mentioned in the document for performance comparison in a clinical trial sense. The evaluation for substantial equivalence is based on technical, functional, and safety comparisons to already cleared devices.
• Data provenance: Not applicable in the context of a prospective clinical "test set" as none is detailed. The performance claims are backed by adherence to standards and comparison of specifications to predicate devices.

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

• Not applicable. The document does not describe a clinical study involving a test set with expert-established ground truth. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices and the adherence to relevant medical device standards.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set and no expert adjudication process are described in this 510(k) summary.

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

• No. The document does not mention any MRMC comparative effectiveness study. This type of study is more common for AI/CADe devices that assist human readers in interpretation. The Penrith Elettra is a diagnostic imaging system itself, not an AI interpretation tool.

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

• Not applicable. The Penrith Elettra is a diagnostic ultrasound system, not an AI algorithm. Its "standalone performance" is its ability to generate images and perform measurements, which is assessed through technical evaluation and comparison to predicate devices, rather than a specific algorithm-only study. The document states it was "evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility."

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" is primarily:
  • The established safety and effectiveness of the identified predicate devices (Acuson Sequoia K022567, Acuson Cypress K052331, Philips Avalon CTS K023931).
  • Compliance with recognized medical device safety and performance standards (e.g., Track 3 method for acoustic output, electrical/physical safety standards).

8. The Sample Size for the Training Set

• Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/machine learning device that requires a training set.

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

• Not applicable. As no training set is involved for this device, there is no ground truth establishment for a training set.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. It demonstrates safety and effectiveness by establishing substantial equivalence to existing, legally marketed predicate devices through technical comparisons, adherence to standards, and matching indications for use. It does not involve a clinical study with specific test sets, expert ground truth development, or AI algorithm performance evaluation the way a more modern AI/CADe submission might.

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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 Sequoia ultrasound imaging system is intended for use in 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), Transesophageal, Transvaginal, Peripheral Vessels, and Musculosceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance 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.

Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Neonatal Cardiac, Intra-luminal, Intra-Cardiac.

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

The provided document is a 510(k) Pre-market Notification for the Siemens ACUSON Sequoia Ultrasound System. It details intended uses and lists various transducers with their cleared applications. However, it does not contain information about specific acceptance criteria or a study proving device performance against those criteria.

The document states in Section E, "Performance Data": "The Sequoia modifications are verified and validated according to the company's design control process." This is a general statement and does not provide details of a study to demonstrate acceptance criteria. The clearance in this 510(k) is based on substantial equivalence to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)), not on new performance data demonstrating meeting specific acceptance criteria for a novel functionality.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission is based on substantial equivalence to a predicate device, not on meeting new quantitative performance criteria described in this document.

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

Not applicable/Not mentioned. No specific test set or data provenance for proving performance against acceptance criteria is described. The document indicates that prior applications for existing transducers were "previously cleared by the FDA under premarket notifications" (e.g., #K052410, #K051139, etc.), implying their performance was established in those earlier submissions.

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

Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned.

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

Not applicable/Not mentioned. The submission is for an ultrasound system and transducers, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not mentioned.

7. Type of Ground Truth Used

Not applicable/Not mentioned. The document relies on "previously cleared" indications for use from predicate devices.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

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

Not applicable/Not mentioned.

Additional Information from the Document:

• Acceptance Criteria (General): The device (and its modifications) are verified and validated according to the company's design control process. This implies internal acceptance criteria for design validation, but the specifics are not disclosed in this summary.
• Proof of Meeting Acceptance Criteria: The submission relies on "substantial equivalence" to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)) for its intended uses and technological characteristics. The performance of individual transducers for specific clinical applications (e.g., Fetal, Abdominal, Cardiac) is indicated by "P=previously cleared by the FDA under premarket notifications" or "N=New Indication" for specific modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Harmonic Imaging). This means the performance for these indications was established in earlier 510(k) submissions, not in this current one.

In essence, this 510(k) is a "Special 510(k)" submission, which is typically used for modifications to a manufacturer's own legally marketed device. The focus is on demonstrating that the changes do not affect the safety and effectiveness of the device as cleared in the predicate, rather than generating new performance data against specific, public-facing acceptance criteria for a novel technology.

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The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), 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 guidance 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.

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 93/42/EEC Medical Device Directive . Safety and EMC Requirements for Medical Equipment . . EN 60601-1 · EN 60601-1-1 EN 60601-1-2 . ISO 10993 Biocompatibility . The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

The provided document is a 510(k) Pre-Market Notification for the ACUSON Sequoia™ Ultrasound System. It primarily outlines the substantial equivalence to a previously cleared device (K051139) and lists the intended uses for various transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document details the intended uses for a wide range of transducers and clinical applications, stating that these uses were "P=previously cleared by the FDA" under various earlier 510(k) notifications. This indicates that the current submission relies on the prior clearances for its claimed performance.

Therefore, since no new performance study is described in this document, the requested information cannot be provided based on the input text.

Here's a breakdown of why each section cannot be addressed based on the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document is a 510(k) submission primarily establishing substantial equivalence to a predicate device and listing intended uses for transducers already cleared. It does not present new performance data or acceptance criteria in the context of a new study.
2. Sample size used for the test set and data provenance: No new test set is described. The document refers to "previously cleared" applications, implying that any testing was conducted for earlier submissions.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size: Not applicable. The document does not describe any MRMC study or AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This document pertains to an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable, as no new ground truth establishment is described.
8. Sample size for the training set: Not applicable, as no AI algorithm or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies.

The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.

The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Windows 2000 Professional™ Operating System standards. The Image-Arena/Research-Arena Applications are a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions. The Image-Arena/Research-Arena Applications software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product lines Echo-View and Echo-Com and Siemens Axius™ software applications. The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician.

The Image-Arena/Research-Arena Applications offer features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, TomTec- file formats) as well as analogue video acquisition in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used.

Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, Power Amplitude Doppler mode, Color Doppler mode, Doppler Tissue Imaging and 3D/4D imaging modes.

The provided 510(k) summary for the TomTec Imaging Systems Image-Arena/Research-Arena Applications does not contain the detailed information necessary to answer all parts of your request. This document is focused on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics, rather than providing a detailed report on a specific performance study with acceptance criteria.

While the document states that "Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release," it does not provide the specifics of these tests.

However, I can extract what is available and indicate where information is missing:

Acceptance Criteria and Study for TomTec Image-Arena/Research-Arena Applications

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or the numerical results from performance tests. It relies on a general statement of conformance to internal specifications.

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

• Test Set Sample Size: Not specified. The document only mentions "Software testing and validation were done at the module and system level."
• Data Provenance: Not specified. It's unclear if the test data was retrospective or prospective, or its country of origin. Given the company is German-based, it's possible some data was from Germany, but this is an inference.

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

• Number of Experts: Not specified. The document states "Test results were reviewed by designated technical professionals," but does not specify their number, roles, or qualifications (e.g., radiologists, cardiologists).
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document only indicates review by "designated technical professionals." No details on how discrepancies or disagreements were handled are provided.

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

• MRMC Study: No, this document does not describe an MRMC comparative effectiveness study. The device is a "software tool package designed for analysis, documentation and archiving" and an "image management system," not an AI diagnostic algorithm meant to directly improve human reader performance in interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance would not be directly applicable or expected for this type of device.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, implicitly. The document describes "Software testing and validation were done at the module and system level." This implies that the software's functionality, such as image import, processing, measurement capabilities, and archiving, was evaluated for its accuracy and functionality in isolation, conforming to its "design intent" and "system performance specifications." However, no specific details or results of these standalone tests are provided, particularly for advanced analysis features like "Axius Quantitative Strain Rate Imaging" or "Axius Edge Assisted Ejection Fraction."

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. For a software suite of this nature, ground truth would likely refer to objective verification of its functionality (e.g., successful import/export, accurate calculation of measurements against known inputs, proper archiving and retrieval) rather than clinical diagnostic ground truth like pathology or outcomes data. If clinical features like "Axius Edge Assisted Ejection Fraction" involve automated measurements, the ground truth would be precise, independently verified measurements from the images, potentially established by expert consensus or comparison to gold standard techniques. However, this is not detailed.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) summary describes a software platform and applications that combine functionalities of previously cleared devices and update them for new operating systems. There is no indication that this specific submission involves a machine learning algorithm requiring a "training set" in the modern sense. It appears to be rule-based or algorithmic, rather than data-driven AI that learns from a large training dataset.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a traditional "training set" for a machine learning model, the establishment of ground truth for such a set is not discussed.

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Ultrasound imaging or fluid flow analysis of the human body as follows: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes.

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect 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) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

The provided text is a 510(k) Summary for the Siemens Medical Solutions USA, Inc. Sequoia Diagnostic Ultrasound System. It describes the device, its intended uses, and lists safety standards it conforms to. However, it does not contain any information about acceptance criteria, specific performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods.

The document primarily serves to establish substantial equivalence to a predicate device (Sequoia Diagnostic Ultrasound System Signature II, K022567) and outlines the approved clinical applications and imaging modes for various transducers. The tables presented are "Indications for Use Forms," indicating what the device is cleared for, not how its performance was evaluated against specific criteria.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary," which typically focuses on substantial equivalence rather than detailed performance study results.

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The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The provided 510(k) summary for the VPan Module to the TechnosMP Ultrasound Imaging System does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial with performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative image quality scores). It relies on a comparison to a predicate device.

The "Comparison Chart for Substantial Equivalence" serves as the primary "acceptance criteria" by showing the new device functions similarly to the predicate.

Reported Device Performance: The document states that the VPan Module (the subject device) "provides panoramic, wide field-of-view images for easier orientation of anatomy and pathology." The implicit performance is that it performs these functions equivalently to the predicate device. No quantitative performance metrics are provided.

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

The document does not describe a test set or data provenance for a performance study. Clinical data is not typically required for 510(k) submissions that demonstrate substantial equivalence through comparison to predicate devices, especially for devices like this that are modifications or additions to existing ultrasound systems. The focus is on technical characteristics and intended use.

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

Not applicable. No ground truth establishment for a test set is described as there isn't a performance study evaluating diagnostic capabilities against a reference standard.

4. Adjudication Method for the Test Set

Not applicable. No test set or independent adjudication 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

Not applicable. This device is an ultrasound imaging module, not an AI or CAD (Computer-Aided Detection) system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This is an imaging module, not an algorithm, so standalone performance is not relevant in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no performance study described that would require establishing a ground truth. The submission relies on demonstrating the new module's technical similarity and equivalent intended use to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is an ultrasound imaging module, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set mentioned or implied.

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