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The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-recal, Trans-vaginal, Muscularive, Pedialit, Sinan Organis, Neonalia, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

The ACCUVIX XG is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler image and Colopher the Gala as B mode, W mode, W mode, Color Doppler imaging, 3D imaging mode (real time 4D ) imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The ACCUVIX XG also gives the operator the ability to measure anatomical structures and offers and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX XC has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document is a 510(k) Premarket Notification summary for the ACCUVIX XG Diagnostic Ultrasound System and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices rather than directly proving performance against acceptance criteria for a novel AI device. Therefore, much of the requested information regarding AI device-specific performance studies is not present.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the context of performance metrics for an AI algorithm, nor does it report performance against such criteria. The device is a diagnostic ultrasound system seeking substantial equivalence to predicate devices, focusing on safety standards and intended uses.

The "performance" described relates to the device's adherence to various product safety standards. The document states:
"The ACCUVIX XG has been designed to met the following product safety standards:"

• UL 60601-1, Safety requirements for Medical Equipment
• CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
• EC60601-2-37, Diagnostic Ultrasound Safety Standards
• EN/IEC60601-1, Safety requirements for Medical Equipment
• NEMALID -1-2, EMC requirements for Medical Equipment
• NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• IEC 61157, Declaration of the acoustic output
• ISO10993-1, Biocompatibility

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

Not applicable. This is a traditional medical device submission (ultrasound system), not an AI device that would typically involve a test set for algorithm performance evaluation. The "test set" in this context would refer to internal validation of adherence to safety and performance standards, likely using physical testing on the device itself and its components, rather than a dataset of patient images. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device submission for demonstrating substantial equivalence.

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

Not applicable. As this is not an AI device requiring ground truth for algorithm performance, no experts were used in this specific context for establishing ground truth of a test set. The validation would be against established engineering and safety standards.

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

Not applicable. No adjudication method for a test set is mentioned, as this is related to a traditional medical device demonstrating substantial equivalence, not an AI algorithm evaluation.

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 is not an AI device, so no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

Not applicable. The ACCUVIX XG is a diagnostic ultrasound system, which inherently involves a human operator (human-in-the-loop) for image acquisition, interpretation, and diagnosis. It is not a standalone AI algorithm.

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

Not applicable. As this document pertains to the substantial equivalence of an ultrasound imaging device, the "ground truth" relates to compliance with engineering, safety, and acoustic output standards, rather than clinical diagnoses established by expert consensus, pathology, or outcomes data for an AI algorithm.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no mention of a "training set" for an algorithm.

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

Not applicable. As this is not an AI device, there is no training set mentioned, and therefore no method for establishing ground truth for a training set.

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The SONOACE R5 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral vessel.

The SONOACE R5 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes. The SONOACE RS also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R5 has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displaved.

The provided text is a 510(k) Premarket Notification for the SONOACE R5 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data, sensitivity, specificity, or reader studies.

The document focuses on:

• Substantial Equivalence: The primary assertion is that the SONOACE R5 is substantially equivalent to the SONOACE R3 (K101829) and SONOACE R7 (K102065) diagnostic ultrasound systems. This means it has the same intended use and similar technological characteristics to legally marketed devices, or has different technological characteristics but does not raise different questions of safety and effectiveness.
• Safety Standards: The document lists various general product safety and acoustic output standards (e.g., UL 60601-1, IEC60601-2-37, NEMA UD-2/3, ISO10993-1) that the device has been designed to meet. Meeting these standards is a form of acceptance criteria, but they relate to general device safety and acoustic output, not specific diagnostic imaging performance metrics (like sensitivity/specificity for a particular clinical application).
• Intended Use and Clinical Applications: It outlines the broad range of clinical applications for which the system and its transducers are intended (e.g., Fetal, Abdominal, Cardiac Adult, Peripheral Vessel).

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, or expert details because this information is not present in the provided 510(k) summary. A 510(k) notification often relies on substantial equivalence and non-clinical performance data (like meeting engineering standards) rather than presenting new clinical study data with detailed performance metrics like sensitivity/specificity for a specific diagnostic task.

If such a study were required and performed, it would typically be detailed in a separate section of a more extensive submission, which is beyond the scope of this particular 510(k) summary.

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The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal. Pediatric. Small Organs, Adult Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatric, Peripheral vessel.

The SONOACE R7 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, 3D imaging mode or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document is a 510(k) summary for the SONOACE R7 Diagnostic Ultrasound System, which is a premarket notification to the FDA for a medical device. This type of submission generally demonstrates substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against human readers or pathology.

Therefore, the provided document does not contain information related to:

• A table of acceptance criteria and reported device performance for clinical endpoints.
• Sample sizes used for a test set or data provenance in the context of clinical performance evaluation.
• Number and qualifications of experts used to establish ground truth for a test set.
• Adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human reader improvement with AI, or standalone algorithm performance.
• Sample size for a training set or how ground truth for the training set was established.

Instead, the document focuses on regulatory aspects to demonstrate substantial equivalence to previously cleared devices.

Here's the relevant information that can be extracted from the provided text:

1. Acceptance Criteria and Device Performance:

The document describes the device's adherence to various safety and performance standards rather than clinical acceptance criteria based on disease detection or diagnostic accuracy. The device's "performance" in this context refers to its technical capabilities and compliance with established industry and regulatory standards.

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

Not applicable. The document describes a substantial equivalence submission, which typically relies on comparisons to predicate devices and adherence to recognized standards, rather than new clinical studies with test sets of patient data.

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

Not applicable, as no external clinical test set with ground truth was described in this 510(k) summary for device performance evaluation.

4. Adjudication method for the test set:

Not applicable, as no external clinical test set with ground truth was described.

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

Not applicable. This is a diagnostic ultrasound system, not an AI-assisted diagnostic device, and no MRMC study or AI performance evaluation is mentioned.

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

Not applicable. This is a diagnostic imaging system, not a standalone algorithm.

7. The type of ground truth used:

Not applicable in the context of clinical performance evaluation against disease. The "ground truth" here is the adherence to safety and performance standards and the functional equivalence to established predicate devices.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device that would typically involve a specific training set of data.

9. How the ground truth for the training set was established:
Not applicable.

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The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

The EKO 7 is a dedicated cardiac purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, Harmonic imaging, PW spectral Doppler mode, CW spectral Doppler mode or as a combination of these modes. The EKO 7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The EKO 7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) Premarket Notification for the EKO 7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, and MRMC comparative effectiveness studies is not available in the provided text for the EKO 7 Diagnostic Ultrasound System itself.

The document primarily outlines:

• Device Description: The EKO 7 is a mobile, software-controlled diagnostic ultrasound system for cardiac purposes and other applications. It acquires and displays ultrasound data in various modes (B-mode, M-mode, Doppler, Harmonic imaging, etc.).
• Intended Uses: Diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications include Fetal, Abdominal, Pediatric, Small Organs, Adult Cephalic, Trans-esophageal, Muscular-Skeletal, Cardiac Adult, Cardiac Pediatric, and Peripheral-vessel.
• Technological Characteristics: The device is stated to be substantially equivalent to previously cleared ACCUVIX V20 and V10 systems.
• Safety Standards: The EKO 7 has been designed to meet several product safety standards (e.g., UL 60601-1, IEC60601-2-37, NEMA UD-2).
• Transducers: A list of transducers compatible with the EKO 7 system is provided, along with their respective cleared indications for use, indicating whether they are new ("N") or previously cleared ("P") for specific modes of operation and clinical applications.

Note on "P" and "N" in Transducer Tables:
The tables for each transducer (e.g., C1-4EC, L3-8, P2-4BA) indicate "N" for new indications and "P" for previously cleared indications. This "P" refers to whether that specific transducer model had its indications cleared under a previous 510(k) submission for a different device, or if the indication was previously cleared for the EKO 7 in an earlier submission (which is unlikely in a new 510(k) for the system itself). It does not imply a performance study comparing the EKO 7's performance against pre-defined acceptance criteria.

In summary: This 510(k) submission establishes substantial equivalence based on technological characteristics and intended uses aligning with predicate devices, and adherence to recognized safety standards. It does not contain the detailed performance study information requested.

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The SONOACE R3 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Trans-rectal, trans-vaginal, Muscular-Skeletal (conventional, Superficial), Cardiac Adult and Peripheral-vessel.

The SONOACE R3 is a general purpose, portable, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes. The SONOACE R3 also gives the operator the ability to measure annomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R3 has real time acoustic output display with two basic indices, a mechanical index and a thermised index, which are both automatically displayed.

The provided text describes the SONOACE R3 Diagnostic Ultrasound System and its intended uses, primarily focusing on general safety and function. It states that the device is "substantially equivalent" to predicate devices (SONOACE X6 and SONOACE PICO) and lists various safety and acoustic output standards it meets.

However, the provided text does not contain any information about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) related to its diagnostic capabilities, nor does it include information about AI/algorithm performance.

The tables detailing clinical applications and modes of operation for the main system and specific transducers (C2-4/20, CN2-8, CN4-9, EC4-9, L5-12/60, LN5-12/40) merely indicate which applications each can be used for ("N" for new indication, "P" for previously cleared). This is about intended use, not performance metrics or acceptance criteria for diagnostic efficacy.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies, which are not detailed here.

Here's a breakdown of what can be extracted, and what is missing:

Information from the document:

• 1. A table of acceptance criteria and the reported device performance:
  • Acceptance Criteria (General): The device has been designed to meet several product safety standards (UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157, ISO10993-1). These are primarily safety and technical performance standards, not diagnostic performance metrics.
  • Reported Device Performance: The document states the device is "substantially equivalent" to predicate devices (K081676, SONOACE X6 Diagnostic Ultrasound System; K061213, SONOACE PICO Diagnostic Ultrasound System). This means its performance is considered equivalent to these previously cleared devices, but no specific performance metrics like sensitivity, specificity, or accuracy are provided.
• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. There is no indication of AI or human reader studies.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. There is no indication of an algorithm or AI.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
• 8. The sample size for the training set: Not mentioned. (Not applicable as no AI/algorithm is described).
• 9. How the ground truth for the training set was established: Not mentioned. (Not applicable as no AI/algorithm is described).

Missing Information (and why it's missing from this document):

The provided document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. For devices like this, especially back in 2010, the primary focus of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical performance studies with detailed statistical metrics, ground truth establishment, or AI algorithm validation. The "acceptance criteria" here are mainly about meeting recognized safety and functional standards, and the "study" is the demonstration of substantial equivalence in form and function.

For AI-enabled medical devices, clinical performance studies with the requested details (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) would typically be required in a more recent submission, and would be a separate, much more detailed section of the regulatory filing. This document predates the common inclusion of such detailed AI performance data in 510(k) summaries.

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The MySono U5 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Obstetrics, Gynecology, Musculoskeletal, Small Parts, Vascular, Cardiac, Pediatric Cardiology, TCD and Urology applications.

The MySono U5 is a hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D Mode, M Mode, Color Doppler Mode (C Mode), Power Doppler Mode (PD Mode), and PW Spectral Doppler Mode (D Mode), 3D imaging mode or as a combination of these modes. The MySono U5 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided document is a 510(k) summary for the MySono U5 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the performance of a novel device against specific acceptance criteria through a clinical study. As such, the document does not contain the detailed clinical study information requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence by demonstrating that the MySono U5 has similar technological characteristics and intended uses as the predicate devices (SONOACE X8 and SONOACE PICO). It lists the intended uses and the various operating modes for different clinical applications for the system and its associated transducers (3D2-6, C3-7, EV4-9, L5-12, P2-4).

The acceptance criteria mentioned are general product safety standards (e.g., UL 60601-1, IEC60601-2-37, EN/IEC60601-1-2) and acoustic output measurement standards (NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157), and biocompatibility (ISO10993). These are engineering and safety standards, not clinical performance metrics. The fact that the device has been designed to meet these standards is stated, implying adherence, but no specific performance data or study details demonstrating compliance with these standards within the context of a clinical study are provided in this K summary.

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The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, intraoperative and etc.

The ACCUVIX V10 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The ACCUVIX V10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

Here's a breakdown of the acceptance criteria and study information for the ACCUVIX V10 Diagnostic Ultrasound System, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification summary for substantial equivalence. It does not contain detailed information about a "study that proves the device meets the acceptance criteria" in the way one might expect for a clinical trial validating an AI algorithm. Instead, it describes how the device meets safety and performance standards and is substantially equivalent to previously cleared predicate devices. Therefore, the "acceptance criteria" here refer to regulatory and safety standards, and "device performance" relates to its intended uses and modes of operation, which are compared to the predicate devices. There is no information about AI-specific validation studies, as this device predates such common regulations.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACCUVIX V10 are based on its compliance with established safety standards and its substantial equivalence to predicate devices, particularly regarding its intended uses and modes of operation. The device performance is deemed acceptable if it meets these existing standards and offers functionalities comparable to or improved over the predicate devices.

Table 1: Acceptance Criteria (Regulatory Standards) and Reported Device Performance

Study Information (Based on the 510(k) Summary)

As this is a 510(k) Pre-Market Notification for a diagnostic ultrasound system (filed in 2009), the "study" referred to is a demonstration of substantial equivalence to legally marketed predicate devices, rather than a clinical trial validating a new AI algorithm's performance against a ground truth.

There is no information in the provided document for the following points, as these types of studies and details are typically associated with performance validation of novel AI/ML devices, which is not the nature of this submission:

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a 510(k) substantial equivalence submission for an ultrasound system. The demonstration of equivalence relies on device specifications, technical characteristics, and safety standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 document is for a general diagnostic ultrasound system, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies as understood today.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of "Study" in this Context:

The "study" or justification for approval in this 510(k) is the demonstration that the ACCUVIX V10 Diagnostic Ultrasound System is substantially equivalent to the following predicate devices:

• K070813, ACCUVIX V10 Diagnostic Ultrasound System
• K092159, ACCUVIX V20 Diagnostic Ultrasound System

Substantial equivalence is established by showing that the device has the same intended use and similar technological characteristics as the predicates, or if there are differences, that these differences do not raise new questions of safety and effectiveness. The document extensively lists safety standards the device meets and its various modes of operation and clinical applications, comparing them to what was previously cleared in the predicate devices. The presence of 'P' (previously cleared) and 'N' (new indication) for various transducers and clinical applications illustrates this comparison to the predicate devices.

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The SQNOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The SONOACE X8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided submission (K093714) for the SONOACE X8 Diagnostic Ultrasound System is a 510(k) Premarket Notification. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics against ground truth.

Therefore, the document does not contain the information requested in questions 1-9 directly. The submission establishes equivalence based on technological characteristics and intended uses being similar to previously cleared devices (K0635580 and K092159). There are no specific acceptance criteria for performance metrics (like sensitivity, specificity, or similar quantitative measures for an AI-enabled device) or a study proving the device meets such criteria as would be found in a de novo or PMA submission.

The document discusses compliance with recognized safety and performance standards for diagnostic ultrasound systems as part of establishing substantial equivalence. These standards are general for the device type, not specific acceptance criteria for a novel AI capability's performance.

Here's what can be inferred or stated from the document, with explanations why other information is not present:

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

• Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity, accuracy) for a specific clinical task. The "acceptance criteria" for a 510(k) submission like this are implicitly demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards for safety and fundamental operational characteristics. The device is assessed against safety standards such as UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO10993-1 (biocompatibility).
• Reported Device Performance: No specific quantitative performance metrics (like sensitivity, specificity, etc.) are reported in the summary that would be tied to clinical acceptance criteria. The performance is deemed substantially equivalent to the predicate devices for the listed clinical applications (General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, etc.) and modes of operation (2D, M-mode, Color Doppler, Power Doppler, PW Spectral Doppler, CW Spectral Doppler, Tissue Doppler Image, 3D/4D).

2. Sample size 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 510(k) summary. For ultrasound systems seeking substantial equivalence, performance is typically confirmed through engineering testing, comparison to predicate devices, and adherence to performance standards, rather than extensive clinical efficacy studies with specific test sets in the same manner as a novel AI algorithm.

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. Ground truth establishment by experts for specific clinical tasks is generally not required for this type of 510(k) submission, as it's not evaluating the diagnostic performance of a novel AI algorithm against a reference standard.

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

This information is not provided. Clinical study design details such as adjudication methods are not typically part of a 510(k) summary for a general diagnostic ultrasound system.

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

This information is not applicable/provided. The SONOACE X8 is a diagnostic ultrasound system, not explicitly described as having AI assistance for human readers in this submission. Therefore, an MRMC comparative effectiveness study regarding AI assistance would not be relevant to this submission.

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

This information is not applicable/provided. The SONOACE X8 is a hardware and software system for generating ultrasound images and data, not a standalone algorithm.

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

This information is not provided. As explained above, specific ground truth for performance evaluation of a novel diagnostic claim is not presented in this substantial equivalence summary. The "ground truth" for a general ultrasound system is its ability to accurately produce images and measurements in accordance with its intended use and technical specifications, which would be verified through engineering and phantom testing, and comparison to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. This submission does not pertain to an AI algorithm that would have a training set.

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

This information is not applicable/provided. This submission does not pertain to an AI algorithm that would have a training set with established ground truth.

In summary: The K093714 document is a 510(k) summary for a diagnostic ultrasound system. Its purpose is to demonstrate substantial equivalence to existing devices and compliance with safety and performance standards for ultrasound technology. It does not provide the kind of performance data (e.g., accuracy, sensitivity, specificity) and study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods) that would be expected for a novel AI-enabled device with specific diagnostic claims requiring clinical validation.

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The ACCUVIX V20 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

The ACCUVIX V20 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The ACCUVIX V20 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided text is a 510(k) Premarket Notification for the ACCUVIX V20 Diagnostic Ultrasound System. It describes the device, its intended uses, and lists safety standards it meets. However, it does not contain any information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance or accuracy, especially relating to AI or algorithmic performance.

Instead, this document focuses on confirming that the ACCUVIX V20 Diagnostic Ultrasound System is "substantially equivalent" to previously cleared predicate devices (K080800 and K052911). Substantial equivalence is primarily demonstrated through meeting safety standards, having similar technological characteristics, and having comparable intended uses, rather than through comparative clinical performance studies against specific quantitative acceptance criteria or ground truth.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for diagnostic performance, nor does it report performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance details are provided for performance evaluation.
3. Number of experts used to establish the ground truth... and qualifications: No ground truth establishment is described for diagnostic performance.
4. Adjudication method: Not applicable as no diagnostic performance study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable; no such study is mentioned.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable; the device is a diagnostic ultrasound system, not an AI algorithm being evaluated for standalone performance.
7. Type of ground truth used: Not applicable as no diagnostic performance study is described.
8. Sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily demonstrates substantial equivalence by referencing existing cleared devices and compliance with recognized safety and performance standards for ultrasound equipment.

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The SONOACE X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.

The SONOACE X6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes on the LCD display. The SONOACE X6 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided document is a 510(k) Pre-Market Notification for the SONOACE X6 Diagnostic Ultrasound System. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone AI performance).

The document focuses on:

• Substantial Equivalence: Comparing the SONOACE X6 to previously cleared ultrasound systems (SA8000 SE, K043455, and SONOACE X8, K063580) based on technological characteristics and intended uses.
• Compliance with Standards: Listing various safety, EMC, and acoustic output standards for medical equipment that the device has been designed to meet.
• Intended Uses: Defining the clinical applications for the system and its associated transducers.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI, is not present in this document. Such information is generally found in more detailed clinical or performance studies for novel devices or specific algorithm clearances, not in a 510(k) for a diagnostic ultrasound system establishing substantial equivalence to existing technology.

However, I can extract the safety and technical standards that serve as performance criteria for the device's design.

Acceptance Criteria and Device Performance (Based on designed compliance with standards):

Since this is a 510(k) submission for a diagnostic ultrasound system based on substantial equivalence, the document does not contain the following information:

1. Sample size used for the test set and data provenance: No specific clinical test set for performance evaluation is described.
2. Number of experts used to establish the ground truth for the test set and their qualifications: No such experts or ground truth establishment process is mentioned.
3. Adjudication method for the test set: Not applicable as no specific test set performance study is detailed.
4. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study typically assesses AI impact on human readers, which is beyond the scope of this type of traditional ultrasound 510(k). The document only establishes substantial equivalence to predicate devices, not AI-enhanced performance.
5. Standalone (algorithm only without human-in-the loop performance) study: Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm.
6. Type of ground truth used: Not applicable. Performance validation against clinical ground truth (pathology, outcomes) is not detailed in this document.
7. Sample size for the training set: Not applicable, as this is not an AI/algorithm submission requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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