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The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80 Exp, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, 175-Endo, 170-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape S90 Exp Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Strain Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.

The provided text describes the Sonoscape Medical Corp.'s S90 Exp Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria related to a performance study for the device's clinical or algorithmic performance, nor does it detail a study that proves the device meets such criteria.

The document primarily focuses on:

• Indications for Use: What the device is intended for (various clinical applications and modes of operation).
• Comparison to Predicate Devices: Explaining how the S90 Exp Series is similar to previously cleared devices in terms of intended use, regulations, safety standards, acoustic output, probes, biopsy brackets, and technical characteristics.
• Non-Clinical Tests: Listing compliance with electrical safety, EMC, acoustic, and software verification standards.

Therefore, I cannot provide the requested information. The text explicitly states:

"No clinical testing was required."

This indicates that, for the purpose of this 510(k) submission, a clinical study demonstrating the device's performance against specific clinical acceptance criteria was not performed or submitted. The substantial equivalence argument is based on the device's similarity to predicate devices and compliance with non-clinical technical standards.

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The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].

In addition, the Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:

-Measurements of abdominal anatomical structures,

• Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
• Measurements of brightness ratio between liver and kidney,
• Visualization of abdominal vascularization, microvascularization and perfusion,
• Quantification of abdominal vascularization and perfusion.

The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

• Measurements of breast anatomical structures
• Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
• Visualization of breast structures and micro-vascularization
• · Visualization of breast morphology using shearwave elastography and micro-vascularization 2D mapping.

The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.

The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.

The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.

The provided text is a 510(k) Summary for an ultrasound diagnostic system. It explicitly states in section 8, "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable.".

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance (beyond compliance with technical standards).
• Details of a study proving the device meets acceptance criteria.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document only discusses non-clinical tests (electrical safety, EMC, acoustic output, biocompatibility) which confirmed the device performs according to its intended use and complies with relevant standards. It concludes that the device is "at least as safe and effective as the predicate devices".

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The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

-Measurements of abdominal anatomical structures,

• Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
• Measurements of brightness ratio between liver and kidney,
• Visualization of abdominal vascularization, microvascularization and perfusion,
• Quantification of abdominal vascularization and perfusion.

The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Furthermore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

• Measurements of breast anatomical structures
• · Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
• Visualization of breast structures and micro-vascularization
• Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping

The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor.

An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and submodes as CFI-ColorFlow Imaging,

CPI-ColorPower Imaging-also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Device: SuperSonic Imagine AIXPLORER® MACH30/SUPERSONIC MACH30, AIXPLORER® MACH20/SUPERSONIC MACH20, SUPERSONIC MACH40 Ultrasound Diagnostic Systems.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (AIXPLORER® MACH range sw V2, K191007) and adherence to recognized standards.

However, based on the intended use for liver disease and breast masses, and the discussion of ShearWave™ Elastography (SWE), we can infer the acceptance criteria and reported performance qualitatively:

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

• Sample Size: Not specified. The submission refers to a "clinical evaluation by literature route" and provides a "Summary of literature review." This implies that the performance claims are based on published studies, not a new clinical trial conducted specifically for this 510(k) submission.
• Data Provenance: Retrospective, as it relies on a "literature review." The specific countries of origin for the studies included in the literature review are not mentioned in this document.

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

Not applicable in the context of this submission. Since the clinical evidence is based on a literature review, the experts establishing ground truth would be those involved in the original studies cited, but these details are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as a new test set requiring adjudication was not explicitly created for this submission. The clinical evidence relies on previously published research.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

• MRMC Study: The document explicitly mentions that "Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment" and "increases the inter-observer agreement." This strongly suggests that a form of comparative effectiveness study was done in the literature reviewed, comparing human interpretation with and without SWE. However, it is not explicitly stated as a new MRMC study conducted for this specific 510(k) submission.
• Effect Size: The document uses qualitative terms like "increased specificity" and "significantly improve the positive predictive value," and "almost perfect" intra-operator repeatability and "high inter-observer reproducibility" for SWE. However, no specific numerical effect sizes (e.g., AUC improvement, percentage increase in sensitivity/specificity, or agreement metrics) are provided in this summary.

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

The device is an ultrasound diagnostic system that includes ShearWave™ Elastography functionality. The "clinical evaluation by literature route" focuses on the utility of SWE as an aid to human interpretation. Phrases like "Addition of Shear Wave elastography to conventional B-mode Ultrasound" and "shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses" indicate that the performance described is a human-in-the-loop scenario, where SWE provides information to aid the clinician. Therefore, a standalone (algorithm only) performance study as typically understood for an AI diagnostic device is not described here. The SWE technology itself generates quantitative data (shear wave speed, stiffness) that is interpreted by the user.

7. The Type of Ground Truth Used

Based on the literature review summary for breast masses, the ground truth likely involved:

• Pathology: "Improve the diagnostic accuracy of ultrasound" and "assess the risk of lesion malignancy" strongly imply pathological diagnosis (biopsy results) as the ground truth for breast mass characterization.
• Outcomes Data: "More appropriate management strategies," "accurate cancer size measurements," "correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment" suggest that long-term patient outcomes or confirmed clinical diagnoses were used as ground truth in the cited literature.

For liver disease, although not explicitly stated, ground truth would similarly rely on established diagnostic methods for liver pathology and progression.

8. The Sample Size for the Training Set

Not applicable. This submission is for an ultrasound system with enhanced features (including ShearWave™ Elastography), not a standalone AI model that undergoes a distinct training phase in the typical sense of deep learning or machine learning. The underlying SWE algorithms would have been developed and validated through extensive research, but a "training set" as understood for a new AI algorithm is not detailed here.

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

Not applicable for the same reasons as #8. The document does not describe a new AI model with a dedicated training set. The clinical evaluation relies on previously established literature for the performance of SWE technology.

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TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging (Contrast agent for LVO),TDI,Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View.

TE7/TE5/TE7 Max/ TE5 Max/TE9 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode , Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO),TDI, Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View. This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array and Volume probe.

This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD. TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System. It largely focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailed performance studies against specific acceptance criteria for novel AI features.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement for ground truth is not explicitly provided in this type of regulatory submission. The submission primarily relies on showing that the new features or modifications are "similar to" or "have been cleared with" existing features in predicate devices. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not provide specific quantitative acceptance criteria or detailed performance metrics for the added features like Smart IVC, Smart VTI, Smart B-Line, EPSS, Smart Trace, Auto GA, Smart Bladder, or Smart FHR OB1. Instead, it states that these features are "similar to" or "have been cleared on" predicate devices, implying that their performance is considered equivalent and therefore acceptable.

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

This information is not provided in the document. The submission relies on "similarity" to predicate devices, implying that testing data from those predicate devices supports the current submission, or that specific testing for these features was performed internally without detailing the datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document makes no mention of expert involvement for ground truth establishment related to the new features. Given the approach of "similarity to cleared features," it's likely that established methods of performance evaluation for ultrasound systems were followed, but the specifics are not disclosed.

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

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission does not claim to include AI assistance to human readers that would necessitate such a study; rather, it describes automated measurement and image processing features that are presumably integrated into the device's functionality.

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

While the new features (e.g., Smart IVC, Smart VTI, Smart B-Line, Smart Bladder, Smart FHR OB1) imply automated algorithms perform measurements or detections, the document does not explicitly describe a standalone algorithm-only performance study. The context is the overall ultrasound system, and these features are presented as integrated capabilities of the device.

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

This information is not explicitly stated. Given the nature of ultrasound imaging and a 510(k) submission primarily focused on substantial equivalence for a diagnostic ultrasound system:

• For quantitative measurements (e.g., Smart IVC, Smart VTI, Auto GA, Smart Bladder, Smart FHR OB1), the ground truth would likely be established through manual measurements by trained Sonographers/Physicians using validated techniques, or comparison against other gold standard measurement methods if available.
• For image processing and detection features (e.g., Smart 3D, iScape View, Smart B-Line, Smart Trace), the ground truth would likely involve expert visual assessment and consensus by radiologists/cardiologists/specialists interpreting the images and verifying the function's output.
  However, this is inferred, not stated.

8. The sample size for the training set

This information is not provided. The document is a 510(k) summary for an ultrasound system, not a detailed technical report for an AI algorithm. In submissions of this type for devices primarily relying on substantial equivalence, detailed training set information is often not required or included unless the AI component is a truly novel aspect requiring extensive de novo review. The features described are framed as similar to those already cleared.

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

This information is not provided.

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DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, convex array, pencil phased and phased array.

This document is a 510(k) summary for the Mindray DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to predicate devices, not to present a de novo clinical study with specific acceptance criteria related to a novel AI-driven diagnostic performance.

Therefore, many of the requested categories for describing acceptance criteria and study details are Not Applicable (NA) in the context of this 510(k) Pre-Market Notification. This document primarily focuses on demonstrating that the new device, with its added transducers, needle-guided brackets, and features, performs equivalently and safely to previously cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General): The device must be as safe and effective as a legally marketed predicate device, and have the same intended use and technological characteristics, or if there are differences, the differences do not raise new questions of safety and effectiveness and are demonstrated to be safe and effective.

No specific quantitative acceptance criteria or reported device performance metrics in the format of "Accuracy > X%" or "Sensitivity > Y%" are presented in this 510(k) summary because it's for a general diagnostic ultrasound system, not an AI-enabled diagnostic device with specific performance claims for disease detection.

The document demonstrates equivalence through:

• Intended Use: Identical to predicate.
• Technological Characteristics: Employing the same fundamental ultrasonic imaging technology.
• Performance: The new models are stated to have "the same performance and functions with the predicated device DC-80 (K192152)".
• Electrical and Physical Safety: Compliance with recognized standards and acoustic power levels below FDA limits.
• Biocompatibility: Materials for new transducers and needle-guided brackets are either the same as predicate or tested for biocompatibility.

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

NA. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML algorithm for diagnostic performance. The non-clinical tests relate to engineering safety and performance standards (e.g., acoustic output, biocompatibility, electrical safety), not diagnostic accuracy derived from a patient dataset.

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

NA. This is not a study assessing the diagnostic performance of an AI algorithm against expert-established ground truth.

4. Adjudication method for the test set

NA. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

NA. This 510(k) is for a general diagnostic ultrasound system, not an AI-assisted diagnostic tool requiring an MRMC study for human reader improvement. While the device does have "Smart" features (e.g., Smart 3D, Smart Pelvic, Smart Planes FH), the submission does not present a comparative effectiveness study demonstrating the incremental benefit of these features for human readers.

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

NA. This 510(k) is for a general diagnostic ultrasound system, not a standalone AI algorithm. It's an imaging device that produces images for human interpretation, potentially with some "smart" features that assist, but without a claim of standalone diagnostic performance.

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

NA. In a 510(k) for a general ultrasound system, "ground truth" as it pertains to diagnostic accuracy of an AI algorithm is not typically established or required. The "ground truth" implied in this context would be the known physical and electrical properties of the device components and their adherence to engineering standards.

8. The sample size for the training set

NA. This submission does not describe an AI/ML algorithm with a "training set" for diagnostic performance.

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

NA. See point 8.

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The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.

The XBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LED monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D. Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.

The provided text is a 510(k) Summary for the CHISON XBit Series Digital Color Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results designed to prove device performance against specific acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a novel AI/ML device. The focus here is on the similarity of the new device to existing, already cleared ultrasound systems.

Specifically, the document states:

• "7. Clinical Test: No clinical testing was required." This explicitly indicates that no clinical study was conducted for this submission.

Given this, I cannot extract the information required for accepting a device, particularly regarding a study that proves the device meets specific performance acceptance criteria related to AI/ML features. The "Acceptance Criteria" in this context would likely refer to the FDA's requirements for demonstrating substantial equivalence (e.g., similar indications for use, technological characteristics, and safety/performance as a legally marketed predicate device).

However, I can extract information related to the device's assessment of its substantially equivalent nature, which includes functional comparisons. The "SE Analysis" sections do describe what the device's "semi-automated functions" do and compare them to predicate features. These comparisons serve as the basis for the declaration of substantial equivalence, which is the "acceptance" in a 510(k) context.

Let's break down what can and cannot be answered based on the provided text, assuming the "AI" features refer to the "semi-automated functions" mentioned in section 4 and detailed in the SE Analyses (e.g., Auto Follicle, SonoBeam, SonoColor, SonoFusion).

Summary of what can be extracted from the document:

The document describes the XBit Series Digital Color Doppler Ultrasound System, which includes "semi-automated functions" like Auto Follicle, SonoBeam, SonoColor, and SonoFusion. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against novel, quantitatively defined acceptance metrics. Indeed, the document explicitly states: "No clinical testing was required."

However, the "SE Analysis" sections serve as the basis for demonstrating that these "semi-automated functions" are substantially equivalent to features found in predicate devices. This is the closest the document comes to describing how the device "meets acceptance criteria" for these features.

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

Since "No clinical testing was required," there are no explicit quantitative acceptance criteria or reported device performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on functional similarity.

Here's how the document frames the comparison for the "semi-automated functions":

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

• Sample Size: Not applicable. The document states "No clinical testing was required." The "test set" for demonstrating substantial equivalence is the comparison of functional specifications and safety data to predicate devices.
• Data Provenance: Not applicable for a clinical test set. The regulatory submission data provenance is CHISON Medical Technologies Co., Ltd. from China. The comparison is based on the declared specifications and previously cleared status of predicate devices.

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

• Not applicable. No clinical testing with ground truth establishment was conducted.

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

• Not applicable. No clinical testing was performed for which adjudication would be relevant.

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:

• No. The document explicitly states "No clinical testing was required." Therefore, no MRMC study was performed.

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

• Not applicable. No standalone performance evaluation for these "semi-automated functions" is mentioned or appears to have been required. The functions are described as "semi-automated," implying a human-in-the-loop is always present.

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

• Not applicable. As no clinical testing was performed, no ground truth needed to be established for performance evaluation. Ground truth for the predicate devices' original clearances would have been established, but this document does not detail that.

8. The sample size for the training set:

• Not applicable. The document does not provide information on the training set for the "semi-automated functions" (AI/ML components). This level of detail is typically not required for a 510(k) submission unless the AI/ML algorithm represents a significant change in technology or indications from the predicate.

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

• Not applicable. As no information on the training set is provided, how its ground truth was established is also not detailed.

In conclusion, this 510(k) summary for an ultrasound system relies on demonstrating substantial equivalence to predicate devices, and explicitly states that no clinical testing was required. Therefore, the detailed and quantitative information typically sought for AI/ML device acceptance criteria and performance studies (sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document. The "acceptance" of this device is based on its similarity to already cleared devices in terms of indications, technology, and safety/performance characteristics.

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DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.

The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array probe. The software of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is based on the main predicate DP-50, and it has a Moderate level of concern.

This is a 510(k) premarket notification for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System. The submission claims substantial equivalence to predicate devices, primarily the DP-50 Digital Ultrasonic Diagnostic Imaging System (K111435).

The document focuses on demonstrating substantial equivalence rather than presenting formal acceptance criteria with specific performance metrics for a new AI/algorithm. However, it implicitly defines acceptance based on the equivalence of its features and performance to predicate devices.

Here's an analysis of the provided information, focusing on aspects relevant to AI/algorithm performance if new features were indeed algorithm-driven. The new features such as "Smart 3D", "Smart Face", "Smart OB", "Smart Bladder", and "iNeedle" suggest the presence of algorithms or AI components.

Since this is a 510(k) premarket notification, formal "acceptance criteria" and detailed "study results" in the typical sense of a clinical trial for breakthrough devices demonstrating specific performance metrics are often replaced by comparisons to predicate devices and adherence to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission primarily relying on substantial equivalence, explicit quantitative acceptance criteria for each individual "smart" feature (e.g., Smart Face, Smart OB) are not provided in the document in the format of a clinical study. Instead, acceptance is implied by demonstrating that the performance and technological characteristics of the new features are the same as or comparable to those already cleared in predicate devices. The "S/D" column indicates if the feature is "Same" or "Different" from the predicate. For those marked "S" (Same), the implied acceptance criterion is "performance identical to the predicate device."

Here's an interpretation based on the provided comparative tables for the "new added special functions":

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MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology exams.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify*), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify**), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Thoracic/Pleural (Specify****), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Other (Specify***)

*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, eSpacial Navi, Smart 3D mode, Strain Elastography, Contrast imaging (Contrast agent for Liver and LVO) or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

This document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. It does not describe an AI/ML-driven device, therefore, a detailed acceptance criteria table and study results for such a device are not present. However, I can extract the information related to the device's general performance and safety evaluations as presented in the document, which serves as a form of acceptance criteria for a medical device cleared via the 510(k) pathway.

The provided document describes the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System. This is a general-purpose ultrasound system and not an AI/ML device in the sense of providing automated diagnoses or assisting human readers with AI. The "acceptance criteria" for such a device primarily revolve around safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than AI performance metrics like sensitivity, specificity, or AUC.

Here's an analysis of the provided information concerning the device's acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative performance metrics as one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are met by demonstrating compliance with recognized medical device standards and showing substantial equivalence to predicate devices in terms of technology, intended use, and safety/effectiveness.

The reported "performance" is qualitative, focusing on whether the device meets regulatory and safety standards:

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

The document explicitly states "7. Clinical Tests: Not Applicable." This indicates that no clinical study involving human subjects or real patient data (test sets) was performed for this 510(k) submission to demonstrate performance in a clinical setting. The evaluation relied entirely on non-clinical tests (bench testing, engineering validation, adherence to standards).

Therefore, there is no sample size for a test set, nor specific data provenance (country of origin, retrospective/prospective) related to patient data. The "tests" mentioned are primarily engineering and compliance tests.

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

Since no clinical tests or human reader studies were conducted as part of this submission, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.

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

Not applicable. The device is a diagnostic ultrasound system (hardware and general software features), not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader improvement. The document does not mention any AI capabilities that assist human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device, not a standalone algorithm. The "performance" is inherent to the system's ability to acquire and display ultrasound images and perform basic measurements, which is evaluated through engineering and safety standards.

7. Type of Ground Truth Used:

For the evaluation described, the "ground truth" is established by:

• Compliance with recognized standards: The device's technical specifications and safety features are compared against established industry and regulatory standards (e.g., IEC, ISO).
• Substantial equivalence to predicate devices: The functionality, safety, and performance characteristics are determined to be similar enough to already-cleared devices, implying that if the predicate is safe and effective, so is the new device.
• Engineering validation and bench testing: Physical measurements and tests demonstrating that the device operates within specified parameters and does not pose undue risks (e.g., acoustic output, temperature, electrical safety).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device's "training" and validation are part of its design, manufacturing, and quality control processes to ensure it meets its specifications and regulatory requirements.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's development and validation relies on engineering principles, scientific understanding of ultrasound physics, and established medical device safety and performance standards.

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The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

This document describes the 510(k) premarket notification for the ZS3 and z.one pro Ultrasound Systems. This is a notification of intent to market a medical device, asserting its substantial equivalence to previously cleared devices. Therefore, the information provided focuses on demonstrating this equivalence through non-clinical testing and comparison to predicates, rather than extensive clinical studies or formal acceptance criteria for an AI/CADe device.

Based on the provided information, the device is an ultrasound system and not an AI/CADe device. As such, the typical acceptance criteria and study design for AI/CADe devices (multireader multi-case studies, ground truth establishment by multiple experts, defined performance metrics like sensitivity/specificity, etc.) are not applicable to this submission.

The acceptance criteria here pertain to the ultrasound system's performance and safety standards, and the "study" proving acceptance is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an ultrasound system and not an AI/CADe device, the acceptance criteria are based on compliance with recognized safety and performance standards for ultrasound equipment. The "reported device performance" is implicitly that the device conforms to these standards.

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

This document describes a 510(k) submission for an ultrasound imaging system. As such, it does not involve a "test set" or "data provenance" in the sense of a machine learning model's evaluation data. Instead, validation is based on non-clinical tests (electrical safety, acoustic output, biocompatibility, etc.) performed on the physical device and its components, in accordance with recognized industry standards. The data provenance would be the results from these engineering and biological safety tests. The specific "sample size" of devices or components tested is not detailed in this summary but is generally part of standard engineering verification and validation.

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

Not applicable. This is not an AI/CADe device, and therefore, an expert-established "ground truth" for a diagnostic test set is not relevant to its 510(k) submission. The "ground truth" for a device like this is its adherence to safety and performance standards.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of diagnostic interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This is an ultrasound imaging system, not an AI/CADe device designed to assist human readers, so such a study is not relevant.

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

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with established safety and performance standards for diagnostic ultrasound equipment, as detailed in section 7 ("Non-clinical Tests") of the 510(k) summary. This includes standards for electrical safety, acoustic output, biocompatibility, and software development, rather than clinical outcomes or expert consensus on image interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware/software medical device (ultrasound system), not an AI/CADe system that undergoes machine learning training with a specific "training set."

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

Not applicable, as there is no "training set" for this type of device. The specifications and performance are established through engineering design, quality control, and adherence to regulatory standards.

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The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

Here's a breakdown of the acceptance criteria and the study information for the DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state specific sample sizes for test sets for the performance data. The sections on performance data refer to compliance with standards and guidelines rather than specific study parameters involving patient data.

Regarding data provenance, the document mentions non-clinical tests (biocompatibility, electrical safety, EMC, acoustic power, software verification/validation) and compliance with international standards. There is no mention of patient data (retrospective or prospective) or countries of origin for test data in the provided text.

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

This information is not provided in the document. The non-clinical tests described involve compliance with established standards, which don't typically involve human expert ground truth for comparative performance in the same way clinical studies do.

4. Adjudication Method for the Test Set:

This information is not provided in the document. The tests performed are primarily technical and regulatory compliance checks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:

This information is not provided in the document. The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." An MRMC study would be a type of clinical study.

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

The document describes the device as a "software controlled, ultrasonic diagnostic system" with various "Main Added Features" (e.g., Ultrasound Fusion Imaging, Smart Pelvic Floor, STE/STQ, Strain Elastography, Smart Face, Smart Planes FH, Glazing Flow, Fusion RESP). While these features are algorithm-based, the document does not explicitly detail standalone performance studies for these specific algorithms, nor does it refer to them as "AI" in the context of standalone performance evaluation. The evaluation focuses on overall system compliance with safety and effectiveness standards, and the capabilities of these features as part of the system.

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

For the non-clinical tests detailed, the "ground truth" is implied by the international and regulatory standards themselves (e.g., IEC, ISO, FDA guidance limits). For instance, acoustic power output is compared against specified limits, and electrical safety against defined safety requirements. There is no mention of clinical ground truth (like pathology or outcomes data) because clinical studies were not conducted.

8. The Sample Size for the Training Set:

This information is not provided in the document. The document describes specific software features but does not delve into the development or training of any potential machine learning components within these features.

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

This information is not provided in the document, as details about training sets and their ground truth establishment are absent.

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