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The Foresight Intracardiac Echocardiography (ICE) System is indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.

The Foresight ICE System is intended to be used for real-time, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features, and intra-procedure complications including pericardial effusions. The system will be comprised of catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via an easy to use interface using multiple methods of input including a mouse, keyboard and/or a touch screen. Casters on the ADM will allow easy movement of the system throughout an EP Lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 10.3F single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of real-time 2D side and forward viewing imaging with the ability to produce rapidly post processed 3D rendered images as well as ECG gated 3D images to reduce motion artifacts. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventricle, fossa ovalis, aortic valve, mitral valve and tricuspid valves. It will display / measure flow velocities using Color and PW Doppler. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, as well as having control over the position of the transducer to allow for multiple angles of images.

The provided document is a 510(k) premarket notification for a medical device (Foresight Intracardiac Echocardiography (ICE) System). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way modern AI/ML device submissions might.

Therefore, many of the requested details, such as specific acceptance criteria for algorithm performance, performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not present in this document.

The document primarily relies on non-clinical data (bench-top evaluations, animal testing, biological safety, electrical safety, acoustic output testing, packaging validation, and compliance with various IEC/ISO standards) to demonstrate substantial equivalence to previously cleared ICE systems. It explicitly states: "No clinical testing is included in the submission. Determination of substantial equivalence Performance is based on an assessment of non-clinical data."

However, I can extract and infer some information based on the type of submission and the data that is provided.

Acceptance Criteria and Study for Foresight Intracardiac Echocardiography (ICE) System

Based on the provided 510(k) summary (K162789), the device is a diagnostic ultrasound system (ICE) intended for visualization of cardiac and great vessel anatomy. The "acceptance criteria" in this context are not quantitative performance metrics for an AI algorithm, but rather the demonstration of substantial equivalence to predicate devices through engineering and non-clinical testing. The study supporting this is a series of non-clinical tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound imaging system without specific AI algorithms requiring performance metrics like sensitivity/specificity for disease detection, the "acceptance criteria" are related to product specifications, safety, and functionality, demonstrating equivalence to the predicate.

2. Sample Size for Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of typical AI/ML validation with a "test set" of patient data. The "test set" here refers to physical devices undergoing various engineering and safety tests. The document does not specify the number of devices or components tested, but implies standard engineering testing practices.
• Data Provenance: The data comes from non-clinical testing conducted by Conavi Medical Inc. (Canada-based). It is not patient data (retrospective or prospective), but rather lab, benchtop, and animal model data.

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

• Not applicable. This submission does not involve an AI algorithm where human experts establish ground truth from patient data. The "ground truth" for the device's functionality is established by engineering specifications, relevant IEC/ISO standards, and the performance of predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert labeling of medical images. Testing involves objective measurements against engineering specifications and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "No clinical testing is included in the submission." Therefore, no MRMC study was conducted comparing human readers with and without AI assistance, as there is no AI component being evaluated for diagnostic assistance.

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

• Not applicable. This device is an imaging system, not a standalone algorithm. Its performance is inherent to its ability to generate images, which are then interpreted by a human user.

7. The Type of Ground Truth Used:

• The "ground truth" is established by engineering specifications, international safety and performance standards (IEC, ISO, NEMA), and the established performance characteristics of the predicate devices. For example, the "ground truth" for acoustic output is derived from regulatory limits and safe operation ranges for diagnostic ultrasound. "Animal testing" contributes to safety and functional verification, but not to establishing a diagnostic "ground truth" on patient cases.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use machine learning algorithms that require a "training set" of data.

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

• Not applicable. See point 8.

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The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients.

The Foresight ICE System is intended to be used by physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available.

The Foresight ICE System is an imaging system intended for intracardiac and intraluminal ultrasound visualization of cardiac and greater vessel anatomy. The Foresight ICE System is comprised of a 10.3F sterile, single-use catheter intended to operate with Patient Interface Module (PIM) and the Hummingbird Console.

The Foresight ICE Catheter uses a mechanically scanned single element imaging transducer that allows for both 2D imaging, similar to an existing rotational ICE Catheter, as well as 3D imaging.

The Foresight ICE Catheter is designed to provide ultrasound images of cardiovascular anatomy. It is a mechanically scanning catheter with a single imaging transducer that rotates within the distal end of a deflectable sheath. The distal tip of the sheath is shaped as a dome and made of an acoustically transmissive material (that is also visually transparent). The distal 10 cm of the catheter can be deflected in a single direction by extending the deflection controller on the handle near the proximal end of the catheter.

The Hummingbird Console is a cart based console that connects to the PIM. It is used to generate and transmit ultrasound imaging energy to activate an ultrasound transducer located at the distal tip of the Foresight ICE Catheter, and then acquire received ultrasound imaging data from the catheter. It then processes imaging data and displays it to the users. It consists of two displays - one for a technician or nurse and one for the physician. It also provides user interfaces for user input.

The PIM serves as the interface between the single-use catheter and the Hummingbird Console. It acts as a relay for electrical ultrasound signals between the Hummingbird Console and catheter. It contains a motor and associated drive system to rotate the transducer imaging assembly of the catheter.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information about acceptance criteria, study design, and performance outcomes is not explicitly available in this document.

However, I can extract information related to the device's technical characteristics and the types of testing performed to support its safety and efficacy.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical study evaluating diagnostic accuracy or clinical outcomes. Instead, it presents a comparison of the new device's technical specifications with those of the predicate device to demonstrate substantial equivalence.

Key comparisons highlighting "performance" relative to the predicate (implicitly, the acceptance is that the new device is "similar to" or "does not adversely affect" the predicate's performance):

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

This document does not describe any clinical test sets, sample sizes, or data provenance (country, retrospective/prospective) for evaluating device performance in humans or animals. The testing described focuses on bench and laboratory testing against international standards for safety and technical performance.

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):

Not applicable. No clinical test set or ground truth establishment by experts is mentioned in this submission.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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 imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is not an AI algorithm. It's a medical device for imaging.

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

For the technical performance evaluation described (e.g., acoustic output, electrical safety, biocompatibility, sterilization), the "ground truth" is adherence to established international standards (e.g., IEC, ISO, NEMA) and engineering specifications, verified through laboratory testing. There is no mention of clinical ground truth (pathology, expert consensus, outcomes data).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The "study" or rather, the evidence provided to demonstrate that the device meets its (largely implied) acceptance criteria for substantial equivalence to the predicate, consists of a comprehensive battery of bench and laboratory verification and validation testing.

This testing was conducted in compliance with a list of relevant international standards to demonstrate:

• Biological Safety: ISO 10993-1 (biocompatibility)
• Electrical Safety and Performance: IEC 60601-1 (3rd edition), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment), IEC 60601-2-37 (ultrasound medical diagnostic and monitoring equipment).
• Sterilization: ISO 11135 (Ethylene Oxide sterilization validation for medical devices).
• Usability: IEC 60601-1-6.
• Acoustic Output: Tested per IEC 60601-2-37:2007 (and deemed analytically equivalent to NEMA UD-2 performance). The device was shown to have reduced acoustic output (Max Pressure, MI, PRF) compared to the predicate, which is presented as a safety improvement ("reduces risk of tissue bioeffects").
• Functional Equivalence: Technical specifications of the catheter and console (e.g., imaging frequency, imaging modes - B-mode), physical dimensions, and operational characteristics were compared directly to the predicate. Differences (like the 10.3F OD, improved tip directionality, and 3D imaging capability) were justified as either similar enough not to raise new safety/efficacy concerns or as enhancements that do not hinder the primary function of the device compared to the predicate. The "worst case uncertainty of any depth measurement is +/- 1.2mm" is a specific performance result mentioned for the device's measurement capability.

The conclusion is that based on the Intended Use, Indications for Use, product technical information, performance evaluation (through standards compliance and direct comparison), and standards compliance, the Colibri Foresight ICE System has shown to be substantially equivalent to the cited predicate device (Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System, K980851). No human clinical trials were described to prove this equivalence.

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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 Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.

The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The provided text states that "additional device testing was not required" and does not describe any specific studies conducted for this 510(k) submission. Instead, it relies on substantial equivalence to predicate devices (K042381, K062084, K992631). Therefore, information regarding acceptance criteria, study design elements (sample size, ground truth, expert qualifications, adjudication methods), or AI-specific details (MRMC studies, standalone performance, training set) is not available in the given document.

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

No acceptance criteria or reported device performance data are provided in the document from a new study. The submission relies on substantial equivalence to predicate devices based on identical or substantially equivalent intended use, method of operation, construction, and materials.

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

Not applicable. No new device performance study was conducted as stated in the document: "As there is no change in the design of the device, additional device testing was not required."

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)

Not applicable. As no new device performance study was conducted.

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

Not applicable. As no new device performance study was conducted.

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 a medical catheter for visualization and delivery, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical catheter and does not involve an algorithm with standalone performance.

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

Not applicable. As no new device performance study was conducted.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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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 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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