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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The CT system is indicated for low dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society.

This proposed device Revolution Vibe is a general purpose, premium multi-slice CT Scanning system consisting of a gantry, table, system cabinet, scanner desktop, power distribution unit, and associated accessories. It has been optimized for cardiac performance while still delivering exceptional imaging quality across the entire body.

Revolution Vibe is a modified dual energy CT system based on its predicate device Revolution Apex Elite (K213715). Compared to the predicate, the most notable change in Revolution Vibe is the modified detector design together with corresponding software changes which is optimized for cardiac imaging providing capability to image the whole heart in one single rotation same as the predicate.

Revolution Vibe offers an accessible whole heart coverage, full cardiac capability CT scanner which can deliver outstanding routine head and body imaging capabilities. The detector of Revolution Vibe uses the same GEHC's Gemstone scintillator with 256 x 0.625 mm row providing up to 16 cm of coverage in Z direction within 32 cm scan field of view, and 64 x 0.625 mm row providing up to 4 cm of coverage in Z direction within 50 cm scan field of view. The available gantry rotation speeds are 0.23, 0.28, 0.35, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0 seconds per rotation.

Revolution Vibe inherits virtually all of the key technologies from the predicate such as: high tube current (mA) output, 80 cm bore size with Whisper Drive, Deep Learning Image Reconstruction for noise reduction (DLIR K183202/K213999, GSI DLIR K201745), ASIR-V iterative recon, enhanced Extended Field of View (EFOV) reconstruction MaxFOV 2 (K203617), fast rotation speed as fast as 0.23 second/rot (K213715), and spectral imaging capability enabled by ultrafast kilovoltage(kv) switching (K163213), as well as ECG-less cardiac (K233750). It also includes the Auto ROI enabled by AI which is integrated within the existing SmartPrep workflow for predicting Baseline and monitoring ROI automatically. As such, the Revolution Vibe carries over virtually all features and functionalities of the predicate device Revolution Apex Elite (K213715).

This CT system can be used for low dose lung cancer screening in high risk populations*.

The provided FDA 510(k) clearance letter and summary for the Revolution Vibe CT system does not include detailed acceptance criteria or a comprehensive study report to fully characterize the device's performance against specific metrics. The information focuses more on the equivalence to a predicate device and general safety/effectiveness.

However, based on the text, we can infer some aspects related to the Auto ROI feature, which is the only part of the device described with specific performance testing details.

Here's an attempt to extract and describe the available information, with clear indications of what is not provided in the document.

Acceptance Criteria and Device Performance for Auto ROI

The document mentions specific performance testing for the "Auto ROI" feature, which utilizes AI. For other aspects of the Revolution Vibe CT system, the submission relies on demonstrating substantial equivalence to the predicate device (Revolution Apex Elite) through engineering design V&V, bench testing, and a clinical reader study focused on overall image utility, rather than specific quantitative performance metrics meeting predefined acceptance criteria for the entire system.

1. Table of Acceptance Criteria and Reported Device Performance (Specific to Auto ROI)

Note: The document does not provide the explicit numerical value for the "pre-established acceptance criteria" or the actual "success rate" achieved for the Auto ROI feature.

2. Sample Size and Data Provenance for the Test Set (Specific to Auto ROI)

• Sample Size: 1341 clinical images
• Data Provenance: "real clinical practice" (Specific country of origin not mentioned). The images were used for "Auto ROI performance" testing, which implies retrospective analysis of existing clinical data.

3. Number of Experts and Qualifications to Establish Ground Truth (Specific to Auto ROI)

• Number of Experts: Not specified for the Auto ROI ground truth establishment.
• Qualifications of Experts: Not specified for the Auto ROI ground truth establishment.

Note: The document mentions 3 readers for the overall clinical reader study (see point 5), but this is for evaluating the diagnostic utility and image quality of the CT system and not explicitly for establishing ground truth for the Auto ROI feature.

4. Adjudication Method for the Test Set (Specific to Auto ROI)

• Adjudication Method: Not specified for the Auto ROI test set.

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

• Was an MRMC study done? Yes, a "clinical reader study of sample clinical data" was carried out. It is described as a "blinded, retrospective clinical reader study."

• Effect Size of Human Readers Improvement with AI vs. without AI assistance: The document states the purpose of this reader study was to validate that "Revolution Vibe are of diagnostic utility and is safe and effective for its intended use." It does not report an effect size or direct comparison of human readers' performance with and without AI assistance (specifically for the Auto ROI feature within the context of reader performance). The study seemed to evaluate the CT system's overall image quality and clinical utility, possibly implying that the Auto ROI is integrated into this overall evaluation, but a comparative effectiveness study of the AI's impact on human performance is not described.

  • Details of MRMC Study:
    • Number of Cases: 30 CT cardiac exams
    • Number of Readers: 3
    • Reader Qualifications: US board-certified in Radiology with more than 5 years' experience in CT cardiac imaging.
    • Exams Covered: "wide range of cardiac clinical scenarios."
    • Reader Task: "Readers were asked to provide evaluation of image quality and the clinical utility."

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, for the "Auto ROI" feature, performance was tested "using 1341 clinical images from real clinical practice," and "the tests results in success rates exceeding the pre-established acceptance criteria." This implies an algorithm-only evaluation of the Auto ROI's ability to successfully identify and monitor ROI.

7. Type of Ground Truth Used (Specific to Auto ROI)

• Type of Ground Truth: Not explicitly stated for the Auto ROI. Given the "success rates" metric, it likely involved a comparison against a predefined "true" ROI determined by human experts or a gold standard method. It's plausible that this was established by expert consensus or reference standards.

8. Sample Size for the Training Set

• Sample Size: Not provided in the document.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not provided in the document.

In summary, the provided documentation focuses on demonstrating substantial equivalence of the Revolution Vibe CT system to its predicate, Revolution Apex Elite, rather than providing detailed, quantitative performance metrics against specific acceptance criteria for all features. The "Auto ROI" feature is the only component where specific performance testing (standalone) is briefly mentioned, but key details like numerical acceptance criteria, actual success rates, and ground truth methodology for training datasets are not disclosed. The human reader study was for general validation of diagnostic utility, not a comparative effectiveness study of AI assistance.

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The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The systems have a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.

The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

The Venue, Venue Go, Venue Fit and Venue Sprint systems can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue, Venue Go and Venue Fit systems are capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)

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

• Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
• Data Provenance:
  • Country of Origin: USA and Israel.
  • Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.

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

• Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
• Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).

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

• Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.

7. Type of Ground Truth Used (for ABV Test Set)

• Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.

8. Sample Size for the Training Set (for ABV)

• Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.

9. How the Ground Truth for the Training Set Was Established (for ABV)

• Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.

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EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.

Here's an organized breakdown of the information:

1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)

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Vivid Pioneer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid Pioneer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications:

Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).

Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.

Vivid Pioneer includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.

The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.

The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.

The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.

1. Table of Acceptance Criteria and Reported Device Performance

AI Cardiac Auto Doppler

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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it can be mounted in a variety of ways (e.g., shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. The clinician can use the information provided by calcium scoring to monitor the progression/regression of calcium in coronary arteries overtime, and this information may aid the clinician in their determination of the prognosis of cardiac disease. CardIQ Suite also provides an estimate of the volume of heart fat for informational use.

CardIQ Suite is a non-invasive software application designed to work with DICOM CT data acquisitions of the heart. It is a collection of tools that provide capabilities for generating measurements both automatically and manually, displaying images and associated measurements in an easy-to-read format and tools for exporting images and measurements in a variety of formats.

CardIQ Suite provides an integrated workflow to seamlessly review calcium scoring and coronary CT angiography (CCTA) data. Calcium Scoring has a fully automatic capability which will detect calcifications within the coronary arteries, label the coronary arteries according to regional territories and generate a total and per territory calcium score based on the AJ 130 and Volume scoring methods. Interactive tools allow editing of both the auto scored coronary lesions and other calcified lesions such as aortic valve, mitral valve as well as other general cardiac structures. Calcium scoring results can be compared with two percentile guide databases to better understand a patient's percentage of risk based on age, gender, and ethnicity. Additionally, for these non-contrasted exams, the heart fat estimation automatically estimates values within the heart that constitute adipose tissue, typically between –200 and –30 Hounsfield Units.

Calcium Scoring results can be exported as DICOM SR, batch axial SCPT, or a PDF report to assist with integration into structured reporting templates. Images can be saved and exported for sharing with referring physicians, incorporating into reports and archiving as part of the CT examination.

The Multi-Planar Reformat (MPR) Cardiac Review and Coronary Review steps provide an interactive toolset for review of cardiac exams. Coronary CTA datasets can be reviewed utilizing the double oblique angles to visually track the path of the coronary arteries as well as to view the common cardiac chamber orientations. Cine capability for multi-phase data may be useful for visualization of cardiac structures in motion such as chambers, valves and arteries, automatic tracking and labeling will allow a comprehensive analysis of the coronaries. Vessel lumen diameter is calculated, and the minimum lumen diameter computed is shown in color along the lumen profile.

Distance measurement and ROI tools are available for quantitative evaluation of the anatomy. Vascular findings of interest can be identified and annotated by the user, and measurements can be calculated for centerline distances, cross-sectional diameter and area, and lumen minimum diameter.

Let's break down the acceptance criteria and study details for the CardIQ Suite device based on the provided FDA 510(k) clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific acceptance criteria and performance results for the novel or modified algorithms introduced in the CardIQ Suite.

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

• Heart Segmentation (non-contrast CT exams): 111 CT exams
• Heart Fat Volume Estimate: 111 CT exams
• Lumen Diameter Quantification: 94 CT exams with a total of 353 narrowings across all available test sets.
• Coronary Centerline Tracking and Labeling: "a database of retrospective CT exams." (Specific number not provided for this particular test, but it is part of the overall bench testing.)

Data Provenance: The document states that the CT exams used for bench testing were "collected from different clinical sites, with a variety of acquisition parameters, and pathologies." It also notes that this database is "retrospective." The country of origin is not explicitly stated in the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications (e.g., radiologist with 10 years of experience) for establishing the ground truth for the test sets. The tests are described as "bench testing" and comparisons to a "reference device" (CardIQ Xpress 2.0) or to an expectation of "successfully segmented."

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The performance is reported based on comparisons to a reference device or meeting a quantitative metric (e.g., Dice score, successful segmentation percentage, mean absolute difference).

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

The document does not mention or describe that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on the performance of the algorithms themselves ('bench testing') and their enhancement compared to predicates, rather than human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the studies described are standalone performance evaluations of the algorithms. They are referred to as "bench testing" and evaluate the device's algorithms directly against defined metrics or a reference device, without involving human readers in a diagnostic setting for performance comparison.

7. Type of Ground Truth Used

The type of ground truth used varies based on the specific test:

• Heart Segmentation (non-contrast CT exams) & Heart Fat Volume Estimate: The ground truth for these appears to be implicitly established by what constitutes "successfully segmented" or against which the "Dice score" is calculated. A "predefined HU threshold" is mentioned for heart fat, suggesting a quantitative, rule-based ground truth related to Hounsfield Units within segmented regions.
• Lumen Diameter Quantification: The ground truth for this was established by comparison to diameters from the reference device, CardIQ Xpress 2.0 (K073138).
• Coronary Centerline Tracking and Labeling: The ground truth for evaluating enhancement compared to the predicate is not explicitly defined but would likely involve some form of expert consensus or highly accurate manual delineation, which is then used to assess the "enhancement" of the new algorithm.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only mentions that the "new deep learning algorithm for heart segmentation of non-contrasted exams uses the same model as the previous existing heart segmentation algorithm for contrasted exams, however now the input is changed, and the model is trained and tested with the non-contrasted exams." Similarly for coronary tracking, it states the deep learning algorithm was "retrained to a finer resolution." However, no specific training set sizes are given.

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

The document does not explicitly state how the ground truth for the training set was established. It is noted that the models were "trained," which implies the existence of a ground truth for the training data, but the methodology for its establishment (e.g., expert annotation, semi-automated methods) is not described in the provided text.

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The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.

Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system.

Here's a breakdown of the acceptance criteria and study details for the Aurora system's deep-learning Automatic Kidney Segmentation algorithm, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details for Deep-Learning Automatic Kidney Segmentation Algorithm

1. Sample sized used for the test set and the data provenance:
* Sample Size: 70 planar NM renal studies.
* Data Provenance: Acquired using GEHC systems from:
* 2 hospitals in the United States
* 1 hospital in Europe
* Nature: Retrospective (the studies were "segregated, and not used in any stage of the algorithm development," implying they were pre-existing data).
* Diversity: Served a diverse patient population including a range of ethnicities and demographics, encompassing a range of dynamic renal clinical scenarios, detection technologies, collimators, tracers, scan parameters, and patient age.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts for Bench Testing Ground Truth: One (1).
* Qualifications: "An experienced Nuclear Medicine physician."
* Number of Experts for Clinical Testing Evaluation: Three (3) qualified U.S. readers.
* Qualifications: "Qualified U.S. readers" (further specific qualifications like years of experience or board certification are not detailed).

3. Adjudication method for the test set:
* For Bench Testing Ground Truth: The ground truth contours were reviewed and confirmed by a single experienced Nuclear Medicine physician. This suggests a form of expert consensus, but without multiple experts, it's not a multi-expert adjudication like 2+1 or 3+1. It's best described as single expert confirmation.
* For Clinical Testing: The three qualified U.S. readers independently assessed the quality of segmentation using a 4-point Likert scale. There is no mention of an adjudication process among these three readers, implying their individual assessments contributed to the overall evaluation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not explicitly described.
* The clinical testing involved multiple readers evaluating the quality of the algorithm's segmentation itself, rather than assessing their own diagnostic performance with and without AI. The focus was on the utility and acceptability of the AI output for the readers.

5. Effect size of how much human readers improve with AI vs without AI assistance:
* This information is not provided as a comparative effectiveness study was not explicitly conducted. The study assessed the acceptability of the AI's output, not the improvement in human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance evaluation of the algorithm was done. This is described as "Bench Testing" where the algorithm's generated contours were compared directly against the ground truth (GT) contours using the DICE similarity score. The "clinical testing" involved human readers evaluating the AI output, but the bench testing was algorithm-only.

7. The type of ground truth used:
* Expert Consensus: The ground truth for the bench testing (GT contours) was established by an "experienced Nuclear Medicine physician." While only one physician is mentioned, it's considered an expert-derived ground truth.

8. The sample size for the training set:
* The document does not explicitly state the sample size used for the training set of the deep learning algorithm. It only mentions that the 70 test studies "were segregated, and not used in any stage of the algorithm development," which implies they were distinct from the training data.

9. How the ground truth for the training set was established:
* The document does not explicitly state how the ground truth for the training set was established. It is only mentioned for the test set.

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Sonic DL is a Deep Learning based reconstruction technique that is available for use on GE HealthCare 1.5T, 3.0T, and 7.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for imaging patients of all ages. Sonic DL is not limited by anatomy and can be used for 2D cardiac cine imaging and 3D Cartesian imaging using fast spin echo and gradient echo sequences. Depending on the region of interest, contrast agents may be used.

Sonic DL is a software feature intended for use with GE HealthCare MR systems. It includes a deep learning based reconstruction algorithm that enables highly accelerated acquisitions by reconstructing MR images from highly under-sampled data. Sonic DL is an optional feature that is integrated into the MR system software and activated through purchasable software option keys.

Here's a breakdown of the acceptance criteria and the study details for Sonic DL, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Sonic DL

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific quantitative "acceptance criteria" against which a single "reported device performance" is measured in a pass/fail manner for all aspects. Instead, it presents various performance metrics and qualitative assessments that demonstrate the device's acceptable performance compared to existing standards and its stated claims. For the sake of clarity, I've summarized the implied acceptance thresholds or comparative findings from the quantitative studies and the qualitative assessments.

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

• Quantitative Post Processing Test Set:
  • Sample Size: 15 fully-sampled datasets.
  • Data Provenance: Retrospective, acquired at GE HealthCare in Waukesha, USA, from 1.5T, 3.0T, and 7.0T scanners.
• Clinical Evaluation Studies (Likert-score based):
  • Study 1 (Brain, Spine, Extremities):
    • Number of image series evaluated: 120 de-identified cases.
    • Number of unique subjects: 54 subjects (48 patients, 6 healthy volunteers).
    • Age range: 11-80 years.
    • Gender: 26 Male, 28 Female.
    • Pathology: Mixture of small, large, focal, diffuse, hyper- and hypo-intense lesions.
    • Contrast: Used in a subset as clinically indicated.
    • Data Provenance: Retrospective and prospective (implied by "obtained from clinical sites and from healthy volunteers scanned at GE HealthCare facilities"). Data collected from 7 sites (4 in United States, 3 outside of United States).
  • Study 2 (Brain):
    • Number of additional cases: 120 cases.
    • Number of unique subjects: From 30 fully-sampled acquisitions.
    • Data Provenance: Retrospective, collected internally at GE HealthCare, 1.5T, 3.0T, and 7.0T field strengths.

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

• Quantitative Post Processing: The "ground truth" here is the fully sampled data and the quantitative measurements derived from it. No human experts are explicitly mentioned for establishing this computational 'ground truth'.
• Clinical Evaluation Studies:
  • Study 1: 3 radiologists. Their specific qualifications (e.g., years of experience, subspecialty) are not provided in the document.
  • Study 2: 3 radiologists. Their specific qualifications are not provided in the document.

4. Adjudication Method for the Test Set

The document does not explicitly state a formal adjudication method (like 2+1 or 3+1). For the clinical evaluation studies, it mentions that "three radiologists were asked to evaluate the diagnostic quality of images" and "radiologists were also asked to comment on the presence of any pathology." This suggests individual assessments were either aggregated, or findings were considered concordant if a majority agreed, but a specific arbitration or adjudication process for disagreements is not detailed.

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

• Was an MRMC study done? Yes, the two Likert-score based clinical studies involved multiple readers (3 radiologists) evaluating multiple cases (120 de-identified cases in Study 1 and 120 additional cases in Study 2) for comparative effectiveness against ARC + HyperSense.
• Effect size of human readers improvement with AI vs. without AI assistance: The document states that "Sonic DL 3D images are of diagnostic quality while yielding a substantial reduction in the scan time compared to ARC + HyperSense images." It also noted that "pathology seen in the ARC + HyperSense images can be accurately retained in Sonic DL 3D images." However, it does not quantify the effect size of how much human readers improve with AI assistance (Sonic DL) versus without it. Instead, the studies aim to demonstrate non-inferiority or comparable diagnostic quality despite acceleration. There's no performance gain stated explicitly for the human reader in terms of diagnostic accuracy or confidence when using Sonic DL images compared to conventional images; rather, the benefit is in maintaining diagnostic quality with faster acquisition.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, extensive non-clinical testing was performed as a standalone assessment of the algorithmic performance. This included evaluations using:
  • Digital reference objects (DROs) and MR scans of physical ACR phantoms to measure PSNR, RMSE, SSIM, resolution, and low contrast detectability.
  • A task-based study using a convolutional neural network ideal observer (CNN-IO) to quantify low contrast detectability.
  • Reconstruction of in vivo datasets with unseen data inserted to assess model stability and hallucination risk.
    These studies directly evaluated the algorithm's output metrics and behavior independently of human interpretation in a clinical workflow, making them standalone performance assessments.

7. Type of Ground Truth Used

• Non-Clinical Testing:
  • Quantitative Metrics (PSNR, RMSE, SSIM, Resolution, Contrast Detectability): Fully sampled data was used as the reference "ground truth" against which the under-sampled and reconstructed Sonic DL 3D images were compared.
  • Model Stability (Hallucination): The "ground truth" was the original in vivo datasets before inserting previously unseen data, allowing for evaluation of whether the algorithm introduced artifacts or hallucinations.
• Quantitative Post Processing (Clinical Testing):
  • Fully sampled data sets were used as the reference for comparison of volumetric measurements with Sonic DL 3D and ARC + HyperSense images.
• Clinical Evaluation Studies (Likert-score based):
  • The implied "ground truth" was the diagnostic quality and presence/absence of pathology as assessed by the conventional ARC + HyperSense images, which were considered the clinical standard for comparison. The radiologists were essentially comparing Sonic DL images against the standard of care images without a separate, absolute ground truth like pathology for every lesion.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the Sonic DL 3D deep learning model. It only mentions that Sonic DL is a "Deep Learning based reconstruction technique" and includes a "deep learning convolutional neural network."

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

The document does not describe how the ground truth for the training set was established. It is standard practice for supervised deep learning models like Sonic DL to be trained on pairs of under-sampled and corresponding fully-sampled or high-quality (e.g., conventionally reconstructed) images, where the high-quality image serves as the 'ground truth' for the network to learn to reconstruct from the under-sampled data. However, the specifics of this process (e.g., data types, annotation, expert involvement) are not mentioned in this document.

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Voluson™ Performance 16 / Voluson™ Performance 18 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson™ Performance 16 / Voluson™ Performance 18 clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ Performance 16 / Voluson™ Performance 18 system are intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Based on the provided FDA 510(k) clearance letter, the device in question, Voluson™ Performance 16/18, is a general-purpose diagnostic ultrasound system. The document explicitly states that "The subject of this premarket submission, Voluson™ Performance 16/18 did not require clinical studies to support substantial equivalence."

This means that no clinical study was conducted to prove the device meets specific acceptance criteria based on its performance in a clinical setting against a defined ground truth. Instead, the substantial equivalence determination relies on comparisons to predicate devices, non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and the migration of existing, already-cleared AI features.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (clinical study details, sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance) are not available in this document because a clinical performance study was not deemed necessary for this 510(k) clearance.

Here's a breakdown of what can be extracted from the document:

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

Since no clinical performance study was conducted to establish new acceptance criteria for direct device performance in terms of diagnostic accuracy or reader improvement, a table of this nature cannot be provided from this document. The "acceptance criteria" here are related to non-clinical safety and performance standards for an ultrasound system, and the "reported device performance" is a statement of compliance with these standards and equivalence to predicates.

Regarding the Study That Proves the Device Meets Acceptance Criteria:

As noted, no clinical study was conducted for this specific 510(k) clearance. The basis for clearance is substantial equivalence to legally marketed predicate devices, supported by non-clinical testing and the migration of already-cleared AI features.

Therefore, for the remaining points (2-9), the answer is largely that this information is not applicable or not provided in this 510(k) summary because a de novo clinical performance study was not performed.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a de novo performance study. The AI features were migrated from already-cleared devices (Voluson Expert 22/20/18, K242168), implying their original validation would have occurred with those previous clearances. Details of those previous validations are not in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) 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. No MRMC study was performed for this clearance. The AI features are already cleared on previous devices, and their performance improvement with AI assistance would have been part of those prior clearances, not described here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated for this clearance. Given it's an ultrasound system, the AI features (SonoPelvicFloor 3.0, SonoAVCfollicle 2.0, Fibroid Mapping, SonoLyst Live) are typically integrated tools that assist the sonographer or physician, rather than standalone diagnostic algorithms. Their standalone performance would have been assessed during their original clearance (K242168).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific clearance. For the migrated AI features, their original ground truth establishment would have been part of the K242168 submission.

8. The sample size for the training set: Not applicable, as no new training was described for this submission. The AI features are migrated and not undergoing new development or training for this device.

9. How the ground truth for the training set was established: Not applicable for this submission. This would pertain to the original development and clearance of the migrated AI features, information not provided in this document.

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