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Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.

The Digital Ultrasonic Diagnostic Imaging System is designed to be portable notebook ultrasound systems and mainly include the ultrasound equipment, transducer and adapter. The equipment to complete the ultrasonic imaging function, host completes the image display, measurement, patient information, image storage, and other applications Standard keyboards, touch panels, and buttons, as well as multifunctional editors, mainly control device operations. The display screen is used to display work interfaces, images, and parameters. Different interfaces are used to connect transducers, other devices, or power supplies. There are four different types of transducers, namely large convex, linear array, Micro convex, Intracavity, the frequency scope of different transducers is from 2.5MHz to 11MHz. The system provides a variety of modes for flexibly selecting, which include B-mode, M-mode, Color-mode, Power-mode, PW-mode, and combined modes (i.e., B/M- mode). Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line. The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information.

The provided document is a 510(k) Premarket Notification from the FDA for a Digital Ultrasonic Diagnostic Imaging System (Model: F6). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them in the way a clinical trial or performance study report would.

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 doesn't present a formal table of acceptance criteria and reported device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that the acceptance criteria are met if the device's technical characteristics and performance are comparable or don't raise new safety/effectiveness concerns.

The "Test Summary" section (6.1 Summary of Non-Clinical Tests) lists various international and FDA guidance standards that the device has been evaluated against. Meeting these standards is an implicit "acceptance criterion" for safety, electromagnetic compatibility, and basic performance.

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

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no information about a test set sample size or its provenance in terms of patient data. The "tests" mentioned are non-clinical (bench testing) against standards.

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)

Since there was no clinical study, there is no mention of experts establishing ground truth for a test set.

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

Not applicable as there was no clinical 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

Not applicable. The device is a "Digital Ultrasonic Diagnostic Imaging System," which is a standalone imaging device, not an AI-assisted diagnostic tool that would involve human readers and comparative effectiveness studies.

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

This question typically applies to AI/software as a medical device. The device in question is a diagnostic ultrasound system. Its performance is assessed through its ability to generate images, measure, display, and analyze fluid flow, which is its inherent standalone function. The non-clinical tests listed serve to prove its performance in this standalone capacity by meeting established safety and performance standards relevant to ultrasound technology.

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

For the non-clinical tests, the "ground truth" would be the specifications and requirements outlined in the referenced standards (e.g., specific acoustic output limits, cytotoxicity thresholds, electromagnetic compatibility levels).

8. The sample size for the training set

Not applicable. This device is a diagnostic ultrasound system, not an AI/machine learning model that typically requires a training set of data.

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

Not applicable, as it's not an AI/ML device.

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The diagnostic ultrasound system (DUS 60) is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The DUS 60 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging(eSRI), scan receiving aperture(SRA) and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.

It is designed to produce ultrasound waves into body tissue and present the returned echo information on the monitor; which can be displayed in the following modes: B/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.

The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.

The provided 510(k) summary does not contain information about a study with acceptance criteria and device performance metrics in the way typically associated with AI/ML-driven device evaluations (e.g., sensitivity, specificity, accuracy).

Instead, this submission for the Edan Instruments DUS 60 Digital Ultrasonic Diagnostic Imaging System focuses on Substantial Equivalence to legally marketed predicate devices. The "effectiveness and safety considerations" are primarily based on non-clinical tests and a comparison to predicate devices, asserting that its design and performance are similar.

Therefore, the sections of your request related to acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.

Here's a breakdown of the information that is available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. The submission states: "Clinical test: Clinical testing is not required." The evaluation is based on non-clinical testing and comparison to predicate devices, not on a clinical test set with patient data for performance evaluation.

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

• Not applicable. No clinical test set or ground truth established by experts is mentioned.

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

• Not applicable. No clinical test set or adjudication process is mentioned.

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

• No. This device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool described in the typical sense of a MRMC study for AI. The submission does not mention any AI component or human-in-the-loop performance improvement study.

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

• No. This is a hardware device (ultrasound system), not a standalone algorithm.

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

• Not applicable. No clinical ground truth is mentioned. The ground for "equivalence" is based on adherence to safety and performance standards, and comparison of technical specifications and intended use with predicate devices.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI/ML device requiring a training set.

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

• Not applicable. This submission does not describe an AI/ML device requiring a training set or ground truth establishment.

In summary: This 510(k) submission for the DUS 60 Digital Ultrasonic Diagnostic Imaging System demonstrates substantial equivalence through adherence to recognized electrical, safety, acoustic, and biocompatibility standards, and by affirming that its intended use and general design principles are the same as previously cleared predicate devices. It does not involve or require clinical performance studies, AI/ML components, or associated analyses like those requested in your prompt.

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The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.

The system consists of a main unit, transducers and other accessories.

The provided 510(k) submission for the "Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6" does not contain acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Digital Ultrasonic Diagnostic Imaging System, K091680 from Edan Instruments, Inc.) based on:

• Similar technology characteristics: The current device has similar design principles and electrical classification.
• Same intended use: The indications for use are the same as the predicate device.
• Non-clinical testing: This primarily involves compliance with various safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10) and acoustic output testing.

The document explicitly states: "Clinical test: Clinical testing is not required." This means there was no study performed to establish diagnostic performance metrics (like sensitivity, specificity, accuracy) against a ground truth for the purpose of this 510(k) submission.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be provided from this document.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The submission explicitly states "Clinical test: Clinical testing is not required." for this submission. The evaluation was based on non-clinical engineering tests and comparison to a predicate device.

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

• Not applicable / Not provided. No clinical test set or ground truth was established for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable / Not provided. No clinical test set requiring adjudication was used.

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. This is a submission for a general diagnostic ultrasound system, not an AI-powered diagnostic tool. Clinical testing was also explicitly stated as "not required."

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

• No. This device is a digital ultrasound imaging system, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable / Not provided. For this 510(k) submission, the "ground truth" was the performance and safety established for the predicate device, against which the new device was deemed substantially equivalent through engineering and non-clinical testing.

8. The sample size for the training set:

• Not applicable / Not provided. This is an ultrasound imaging system, not an AI/Machine Learning device that utilizes a training set for model development in the context of diagnostic accuracy.

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

• Not applicable / Not provided. See explanation for #8.

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The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms. obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial). Urology (including prostate). Transrecta and Transvagina.

DUS 60 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: B-Mode, M-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.

The provided text is a 510(k) summary for the Edan Instruments, Inc. Digital Ultrasonic Diagnostic Imaging System, Model DUS 60.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that clinical testing is not required for this device (Section 6, page 1). Instead, effectiveness and safety considerations are addressed through non-clinical tests. Therefore, there are no specific performance metrics or acceptance criteria for disease detection rates or diagnostic accuracy to be reported in a table of device performance in the typical sense for AI/CADe devices.

The acceptance criteria here pertain to compliance with recognized safety and performance standards for medical devices. The reported device "performance" is its compliance with these standards, demonstrating substantial equivalence to predicate devices.

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

• No specific test set or clinical data is mentioned. The device is cleared based on non-clinical testing and substantial equivalence to predicate devices. The phrase "Clinical testing is not required" (Section 6, page 1) confirms this.
• Therefore, there's no information on "sample size for the test set" or "data provenance (e.g. country of origin of the data, retrospective or prospective)."

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

• Not applicable. As no clinical testing or specific test set with ground truth established by experts was required or mentioned, this information is not available.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring expert adjudication is mentioned.

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

• No. The document does not mention any MRMC study. The device is not an AI/CADe system designed to improve human reader performance. It is a diagnostic ultrasound imaging system.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is a hardware and software system for diagnostic imaging, not an algorithm being tested in isolation for specific standalone performance metrics like sensitivity or specificity for disease detection. Its "performance" is its ability to produce ultrasound images and operate according to its specifications and safety standards.

7. Type of Ground Truth Used:

• Not applicable. Since no clinical testing or performance evaluation against a specific disease outcome/diagnosis was required, there is no mention of ground truth types like expert consensus, pathology, or outcomes data. The "ground truth" in this context refers to the compliance with technical and safety standards.

8. Sample Size for the Training Set:

• Not applicable. The device is an ultrasound imaging system, not an AI/ML model that is trained on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As there is no training set mentioned, the establishment of ground truth for such a set is irrelevant.

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The DUS 6/DUS 3 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 6/DUS 3 is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

DUS 3/DUS 6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10.0MHz. The system consists of a main unit, a display and transducers.

The provided document, K091680, is a 510(k) summary for the Edan Instruments DUS 3/DUS 6 Digital Ultrasonic Diagnostic Imaging System. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance metrics like sensitivity, specificity, accuracy, or reader improvement.

Instead, it states:

1. Clinical test: Clinical testing is not required. (Section 6: Effectiveness and Safety Considerations)

This means the submission relies on non-clinical tests and a comparison to predicate devices to demonstrate substantial equivalence, rather than a study with specific clinical performance acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document, specifically:

• A table of acceptance criteria and reported device performance (clinical).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance details.
• Type of ground truth used (clinical).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on non-clinical testing for safety and compliance with standards. Below is a table summarizing what is available regarding non-clinical acceptance criteria and the "study" (non-clinical testing) conducted.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Sample Size: Not applicable as no clinical test set was used for performance validation. Non-clinical tests were performed on the device itself.
• Data Provenance: Not applicable as clinical data was not used for effectiveness.

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

• Not applicable as no clinical ground truth was established by experts for performance evaluation.

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

• Not applicable as no clinical test set required adjudication.

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 MRMC comparative effectiveness study was done. The device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool, and clinical testing was not required for its 510(k) clearance.

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

• Not applicable. This is a hardware imaging device, not a standalone algorithm. Its "performance" refers to image generation and safety, not diagnostic interpretation.

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

• Not applicable for clinical performance. For non-clinical tests, the "ground truth" would be the specifications and requirements of the safety standards (e.g., electrical safety limits, EMC compatibility levels, acoustic output limits, biocompatibility requirements).

8. The sample size for the training set:

• Not applicable as clinical data was not used for training any diagnostic algorithm.

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

• Not applicable as no training set was used with clinical ground truth for a diagnostic algorithm.

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The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), urology, peripheral vascular, intraoperative, pediatric, cephalic, fetal, transrectal, transvaginal, neonatal musculoskeletal (general and superficial).

The DP-6900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode or the combined mode (i.e. B/M Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.

The provided text is a 510(k) summary for the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System. It describes the device's intended use and safety considerations, but does not contain information about explicit acceptance criteria or a study proving the device meets those criteria in terms of diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and acoustic output measurements. It lists various transducers and their clinical applications, indicating which modes (B, M, Combined) are available for each application and whether "Tissue Harmonic Imaging" is an option. However, these tables do not represent performance metrics against acceptance criteria.

Therefore, many of the requested information points cannot be extracted from the given text.

Here is a breakdown of what can and cannot be answered based on the provided input:

In summary, the provided 510(k) summary for the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with recognized safety standards, rather than presenting clinical performance data against specific acceptance criteria.

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