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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, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatricand 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(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D 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.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or sample size/ground truth establishment for training sets.

The document is a 510(k) Premarket Notification for the SONOACE R7 Diagnostic Ultrasound System. It primarily focuses on:

• Device Description and Intended Uses: Explaining what the device is and its clinical applications.
• Technological Characteristics Comparison with Predicates: Demonstrating substantial equivalence to previously cleared devices by comparing features and compliance with standards.
• Bench and Non-Clinical Tests: Stating that the device underwent evaluations for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable standards.
• Conclusion: Asserting the device's safety, effectiveness, and substantial equivalence to predicate devices.
• Indications for Use Statements for various transducers: Listing the specific body parts and modes of operation for each transducer.

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence." This means no clinical studies, and therefore no acceptance criteria or performance data, were generated for this submission. The substantial equivalence argument relies on the inherent safety and performance of the predicate devices and the new device's adherence to relevant safety and performance standards.

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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, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, 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.

The provided text is a 510(k) Summary for the SAMSUNG MEDISON CO., LTD. SONOACE R7 Diagnostic Ultrasound System and its various transducers. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/CADe device.

Instead, the document focuses on demonstrating that the SONOACE R7 (and its transducers) has technological characteristics and intended uses substantially equivalent to previously cleared predicate devices (K102065, SONOACE R7 Diagnostic Ultrasound System; K093714, SONOACE X8 Diagnostic Ultrasound System; and K103722 for specific transducers).

Therefore, I cannot populate the table or answer most of the questions as they pertain to a clinical study demonstrating performance against acceptance criteria for a new clinical indication or an AI/CADe device. The regulatory pathway for this device is based on substantial equivalence, not on proving specific diagnostic performance metrics through clinical trials.

Here's what can be extracted based on the provided text, and where information is not available:

1. Table of acceptance criteria and the reported device performance

This information is not available in the provided document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing or reporting specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc. for a new clinical claim. The "acceptance criteria" here implicitly refer to meeting safety and performance standards equivalent to the predicate devices.

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 available. The submission is a 510(k) for an ultrasound system, not a study reporting diagnostic performance metrics. It does not mention any "test set" in the context of diagnostic accuracy evaluation.

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 available. There is no mention of a test set with ground truth established by experts.

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

This information is not available. There is no mention of an adjudication method for a test set.

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 available. The device described is a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/CADe (Computer-Aided Diagnosis/Detection) device that would involve AI assistance for human readers or require MRMC studies in this context.

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

This information is not available. This is not an AI/CADe device, and therefore "standalone" algorithm performance is not applicable in this context. The device is a tool used by a human operator for diagnostic imaging.

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

This information is not available. No diagnostic performance study using a ground truth is described.

8. The sample size for the training set

This information is not available. There is no mention of a "training set" as this is not an AI/CADe device.

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

This information is not available. There is no mention of a "training set" or its ground truth establishment.

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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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