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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 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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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal organs and vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, MSK Conventional, MSK Superficial, Transcranial Doppler.

The Sonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The system has an electrocardiography (ECG) display feature and support 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 PA 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. The needle guides are single use (disposable).

Here's an analysis of the provided text regarding the acceptance criteria and study for the SONIX Ultrasound Scanner:

Acceptance Criteria and Device Performance for SONIX Ultrasound Scanner

The provided 510(k) summary for the SONIX Ultrasound Scanner (K061827) does not present explicit "acceptance criteria" in terms of specific performance metrics with target values that the device met. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards.

The primary "acceptance criteria" appear to be implicit in the device's compliance with established industry and regulatory standards, and its substantial similarity to predicate devices. The "reported device performance" is primarily articulated through these compliance statements and the operational capabilities described.

Table of Acceptance Criteria and Reported Device Performance

• Complies with UL 2601-1 (Underwriters Laboratories Standards, Medical Electrical Equipment)
• Complies with C22-2 No 601-1 (Canadian Standards Association, Medical Electrical Equipment)
• Complies with EM 60601-1-1-2 (European Norm, Collateral Standard, Electromagnetic Compatibility)
• Complies with IEC 60601-2-37 (Particular requirements for the safety of ultrasonic medical diagnostic equipment)
• Complies with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety. |
  | Acoustic Output Standards Compliance | - Complies with "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by NEMA as UD-3.
• Complies with guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance. |
  | Acoustic Output Limits (Specific Values) | - ISPTA(d): 720mW/cm²
• TIS/TIB/TIC: 0.1 - 4.0 (Range)
• Mechanical Index (MI): 1.9 (Maximum)
• ISPPA(d): 0 - 700W/cm² (Range)
• The stated limits are the same as predicate Track 3 devices. |
  | Functional Equivalence to Predicate Devices | - Substantially equivalent to predicate devices (Ultrasonix Ergosonix 500, ATL HDI 5000 System, Acuson Sequoia) with respect to intended use/indications for use, principles of operation, and technological characteristics.
• Operates identically to predicate devices (piezoelectric material, sound wave transmission/reflection, electrical signal conversion, 2D/M-mode imaging, Doppler shift display).
• Modes of operation (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as predicate devices.
• Transducer patient contact materials are biocompatible.
• Beam forming architecture is very similar to predicate devices.
• Receiving and processing hardware is similar but innovative (programmable system with 2 building blocks, reconfigurable for different imaging modes).
• Image quality adjustment parameters (TGC gain sliders, depth control, angling) are the same as predicate devices. |
  | Intended Use / Clinical Applications (for each transducer) | - Each transducer is indicated for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, MSK Conventional, MSK Superficial, Intraoperative, Intraoperative Neurological, Transcranial Doppler) and modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined modes, Freehand 3D imaging, Live 3D imaging, Directional Power Doppler) as indicated in the "Diagnostic Ultrasound Indications for Use Form" for each specific transducer. "P" against an application/mode indicates "previously cleared by FDA," implying equivalence to predicate devices for these uses. |
  | Biopsy Capability | - The intended use of biopsy is supported by biopsy kits (polymeric brackets, needle guides) which are accessories to the scanner. The brackets prevent incorrect orientation and are designed to accept and retain needle guides. Needle guides are sterile, single-use, and support various needle sizes. |
  | Other Features | - UPS, Wireless, Barcode reader, Data Management for ultrasound QA, ECG display, PA and CW audio output, cine review, image zoom, labeling, measurements and calculations, image storage and review, printing, recording capabilities, DICOM module. These are presented as features of the device, implying they meet appropriate functional standards for such features. |

Study Details:

The provided document describes a 510(k) Premarket Notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting new clinical trials to prove efficacy or establishing new acceptance criteria through extensive studies.

Therefore, the study details you'd typically expect for a software-based AI device are largely not applicable in this context. Here's a breakdown based on the information provided:

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

   • Not explicitly provided. This is not a study that involves a test set of patient data in the way an AI algorithm validation would. The "test" for this device involved demonstrating compliance with standards and comparing technical specifications and intended uses to predicate devices.
   • Data Provenance: Not applicable in the context of clinical performance evaluation with a test set of data. The "data" here would be technical specifications, engineering test results (for acoustic output, electrical safety), and comparative analysis with predicate devices.

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

   • Not applicable. There was no "test set" of clinical cases requiring expert ground truth for this 510(k) submission.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set requiring adjudication was used.

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

   • No such study was done. This is a traditional ultrasound scanner, not an AI-assisted diagnostic tool in the sense of the query. The submission focuses on hardware and software functionality and safety, not on improving human reader performance with AI.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. The device is a diagnostic ultrasound system intended for use by a qualified physician. There is no standalone "algorithm" performance being evaluated independently of human operation.

6. Type of Ground Truth Used:

   • Not applicable in the context of clinical "ground truth" for diagnostic accuracy. The "ground truth" for this submission revolves around:
     • Regulatory Standards: Compliance with electrical safety, EMC, and acoustic output standards (e.g., EN 60601-1, IEC 60601-2-37, NEMA UD-3).
     • Predicate Device Specifications: The technical and performance characteristics of legally marketed predicate ultrasound devices (Ultrasonix Ergosonix 500, ATL HDI 5000, Acuson Sequoia) served as the benchmark for "substantial equivalence."

7. Sample Size for the Training Set:

   • Not applicable. This device does not use a "training set" in the machine learning sense. Its design and development would have involved engineering and calibration, not algorithm training on a dataset of cases.

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

   • Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

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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 Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays. These systems have an electrocardiography (ECG) display feature and support 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 PA 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 provided document is a 510(k) summary for the Ultrasonix Ergosonix 500 Ultrasound, updated with new transducers, applications, and imaging modes. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. This document does NOT contain information about performance acceptance criteria or a study proving the device meets such criteria.

The 510(k) process for ultrasound systems often relies on demonstrating substantial equivalence to already cleared devices and compliance with recognized safety standards (like acoustic output limits) rather than conducting specific clinical performance studies that define and then meet acceptance criteria as one might see for novel diagnostic AI devices.

Therefore, I cannot fulfill all parts of your request based on the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance criteria in the sense of a clinical outcome metric. The document focuses on compliance with general safety standards and equivalence to predicate devices.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical use or diagnostic effectiveness. The performance is implied to be equivalent to the predicate devices.

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

• Not provided. This type of information is not typically part of a 510(k) summary for an ultrasound system focused on hardware and mode updates through substantial equivalence. There is no "test set" in the context of clinical performance evaluation against specific criteria here.

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

• Not applicable. There is no "test set" or ground truth establishment described for diagnostic performance evaluation.

4. Adjudication method for the test set:

• Not applicable.

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 system, not an AI-powered diagnostic tool. No AI component is mentioned, and therefore no MRMC study or effect size related to AI assistance is present.

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

• Not applicable. This is a hardware/software imaging system, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used:

• Not applicable. No ground truth for diagnostic performance is mentioned. The submission focuses on technical specifications, safety (acoustic output), and substantial equivalence to legally marketed predicate devices. The "ground truth" in this context is the established safety and performance of the predicate devices and adherence to regulatory standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of available information:

The document primarily serves as a 510(k) premarket notification to demonstrate that the Ergosonix and Modulo Ultrasound Scanners, including new transducers and applications, are substantially equivalent to legally marketed predicate devices (Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630), ATL HDI 5000 System (K002003), Acuson Sequoia (K973767)).

Acceptance Criteria (Implied - focused on safety and equivalence):

The acceptance criteria are implicitly tied to:

• Compliance with recognized safety standards for medical electrical equipment and a coustic output.
• Demonstration of technological characteristics and intended uses being substantially similar to predicate devices.

Reported Device Performance (Implied - focused on safety and technical specifications):

• Acoustic Output Limits: The devices comply with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.
  • ISPTA(d): 720mW/cm²
  • TIS/TIB/TIC: 0.1 - 4.0 (Range)
  • Mechanical Index (MI): 1.9 (Maximum)
  • ISPPA(d): 0 - 700W/cm² (Range)
• The limits are stated to be the same as predicate Track 3 devices.
• The device operates in modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) identical to predicate devices.
• The beam forming architecture and image quality adjustment parameters are "very similar" or "the same" as predicates.

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) premarket notification process itself, which establishes substantial equivalence through a comparison of technical features, intended use, and adherence to safety standards. No specific clinical performance trial against predefined acceptance criteria is detailed in the provided document.

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The Sequoia system is intended for 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, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

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.

This document is a 510(k) Summary for the Acuson Sequoia Diagnostic Ultrasound System Signature II. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The 510(k) summary focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through adherence to safety standards and a comparison of technological features. It does not include performance metrics or a study demonstrating the device's efficacy or accuracy against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance for market clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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