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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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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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DP-10/DP-30/DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.

The DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, Power + B, Power + PW +B). This system is a Track 3 device that employs an array of probes that include linear array, convex array.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like sensitivity, specificity, or AUC, which are typical for AI/ML-based diagnostic devices.

Instead, the document is a 510(k) summary for a "DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System," which is a traditional medical imaging device. The "study" referenced in the document is a non-clinical test report demonstrating compliance with various electrical, acoustic, and safety standards, rather than a clinical performance study of the device's diagnostic accuracy.

Here's a breakdown of the available information based on your request, highlighting what is not present:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify performance acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the ultrasonic diagnostic imaging system. Instead, it refers to compliance with safety and performance standards.

   The performance relies on its ability to "acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, Power Mode, THI or the combined mode" and perform "specialized measurements of structures and flow, and calculations," which is an inherent function of an ultrasonic diagnostic system rather than a measured performance metric against a specific clinical outcome.

2. Sample size used for the test set and the data provenance:
   This information is not applicable as there was no clinical study evaluating diagnostic performance. The document states: "8. Clinical Studies: Not applicable. The subject of this submission, DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence."

   The non-clinical tests involved evaluating the device against standards, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as there was no clinical study with a test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable as there was no clinical study with 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 applicable. The device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable as the device is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   This information is not applicable as there was no clinical study requiring a ground truth.

8. The sample size for the training set:
   This information is not applicable as the device is a traditional medical imaging system and not an AI/ML-based device that would require a training set.

9. How the ground truth for the training set was established:
   This information is not applicable as there was no training set.

In summary, the provided document details a 510(k) submission for a traditional ultrasonic diagnostic imaging system, and therefore, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with non-clinical safety and performance standards, rather than clinical performance criteria or studies typical for AI/ML devices.

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The DUS-6000 Digital Ultrasonic Diagnostic Imaging System 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 applications by or on the order of a physician or similarly qualified health care professional.

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System 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. 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 to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/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 document is a 510(k) premarket notification for the DUS-6000 Digital Ultrasonic Diagnostic Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states: "Clinical testing is not required."

Therefore, the document does not contain any information about an acceptance criteria table or any study that proves the device meets specific acceptance criteria related to its diagnostic performance. The filing focuses on demonstrating equivalence to a previously cleared device through non-clinical tests (safety standards, acoustic output) and comparison of technical characteristics and intended use.

This means I cannot provide the requested information for acceptance criteria and a study proving device performance, as it is explicitly stated that clinical testing was not performed or required for this 510(k) submission.

Here's a breakdown of what can be extracted or inferred from the provided text, primarily based on the absence of information:

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

• No information available. The document states "Clinical testing is not required." and does not provide any performance metrics or acceptance criteria for diagnostic accuracy or effectiveness.

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

• No test set or clinical data described. Since clinical testing was deemed "not required," there is no information about a test set, sample size, or data provenance.

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. No clinical test set or ground truth establishment is described.

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

• Not applicable. No clinical test set or adjudication process is 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 and no AI involved directly. This device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool. 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 device is a diagnostic ultrasound imaging system, where human operation and interpretation are inherent. No standalone algorithm performance is discussed.

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

• Not applicable. No clinical test set or ground truth establishment is described.

8. The sample size for the training set

• Not applicable. This document describes a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, no training set or ground truth establishment relevant to machine learning is described.

Summary of Device and Basis for Clearance (as per the document):

• Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body in various clinical applications (Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal, cardiac).
• Regulatory Clearance Basis: Substantial equivalence to the predicate device, DUS 60 ultrasound system (K131830), manufactured by EDAN Instruments Inc.
• Evidence for Equivalence:
  • Similar technology characteristics.
  • Same intended use.
  • Same design principle.
  • Same electrical classification.
  • Same accuracy (claimed, but not explicitly demonstrated through clinical performance data in this document).
  • Same needle-guide bracket material, property, and sterilization methods as the predicate.
• Non-Clinical Tests Conducted (relevant to safety and basic performance):
  • IEC 60601-1 Electrical Safety
  • IEC 60601-1-2 Electromagnetic Compatibility
  • IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • Acoustic output testing as per FDA guidelines (September 9, 2008).
  • ISO 10993-1, ISO 10993-5, and ISO 10993-10 Biological Evaluation of medical devices.

The document explicitly states that "Clinical testing is not required," which means the submission relies on non-clinical data, comparison to the predicate device, and adherence to recognized standards to demonstrate safety and substantial equivalence, rather than new clinical performance studies or specific diagnostic acceptance criteria.

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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 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile (with mobile ultrasound trolley), software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

The provided document (K130833) is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging Systems.

Based on the content of this document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through conformity to recognized standards and successful completion of non-clinical tests.

The acceptance criteria for this submission are implicitly that the device performs functionally and safely at least as well as the predicate devices and meets relevant medical device safety standards. The reported device performance is stated as conforming to these standards and being substantially equivalent to the predicate devices.

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

The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission, DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System, does not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of any size used for performance evaluation that is described in this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

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

As no clinical studies or test sets of patient data were conducted or described, no experts were used to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies or test sets of patient data were performed or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC study was done, as the document explicitly states that clinical studies are "Not applicable." The submission relies on substantial equivalence to predicate devices and non-clinical testing.

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

This device is an ultrasonic diagnostic imaging system, not an AI algorithm. Its performance is inherent in its imaging capabilities, which are assessed through technical and safety standards rather than standalone algorithmic performance metrics. Therefore, a "standalone algorithm performance" study as typically understood for AI was not conducted. The non-clinical tests serve as the standalone evaluation of the device's technical performance and safety.

7. The Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" essentially refers to:

• Conformity with established medical device safety and performance standards (e.g., IEC 60601 series, UEMA UD 2, UEMA UD 3, UL 60601-1, ISO14971, ISO 10993-1, IEC 62366, IEC 62304).
• Equivalence to the performance of predicate devices already cleared for market (Mindray DP-20/DP-30 (K113153), Mindray Z6 (K122010), Mindray M7 (K121010)). This implies that the predicate devices' established safety and effectiveness serve as the ground truth reference.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data. The "design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems" (Page 3), which implies robust engineering and manufacturing processes rather than data-driven training.

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

Not applicable, as there is no training set for this type of device.

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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 DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.

The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array, convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 MHz.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against such criteria. The document is a 510(k) premarket notification summary for the Mindray DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging Systems, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance metrics or clinical study results.

The document primarily covers:

• Device Description: General features and modes of operation (B-Mode, M-Mode, combined).
• Intended Use: Broad clinical applications for various patient populations and anatomical regions.
• Comparison with Predicate Devices: Lists several Mindray systems as predicates, stating "They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device."
• Non-clinical Tests: Mentions evaluations for acoustic output, biocompatibility, cleaning/disinfection, and safety standards conformance (ISO 14971, IEC standards, UL 60601-1, etc.).
• Conclusion: Asserts substantial equivalence based on intended uses, traditional clinical practices, FDA guidelines, manufacturing quality processes, and conformity to safety standards.
• Transducer Information: Detailed tables indicating the clinical applications and modes of operation ("P" for previously cleared or "N" for new indication) for each specific transducer model associated with the DP-5 and DP-7 systems. These tables also note additional features like Tissue Harmonic Imaging and Biopsy Guidance.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text. The 510(k) summary format does not typically include this level of detail about specific performance studies for devices demonstrating substantial equivalence to existing cleared devices.

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The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

The provided text is a 510(k) Pre-market Notification for the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System. It focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information, particularly regarding detailed performance metrics, study design, and ground truth establishment, is not present in this document.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's functionality. Instead, it relies on demonstrating that the DP-20 and DP-30 systems are substantially equivalent to predicate devices (Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System (K102991), and M7 Diagnostic Ultrasound System (K103677)).

The "performance" described is in terms of general characteristics and adherence to safety standards.

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

The document does not describe any specific clinical or performance test set (dataset of cases) used to establish quantitative performance metrics. The demonstration of safety and effectiveness relies on adherence to established engineering and medical device standards, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients/images.

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

Not applicable. No ground truth establishment by experts for a specific test set is mentioned, as the submission is not based on a clinical performance study with a new algorithm or diagnostic aid requiring such validation.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) summary.

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 an ultrasound imaging system, and the submission does not involve an AI algorithm or a comparative effectiveness study of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a standalone ultrasound imaging system, not an algorithm. Its "standalone" performance is assessed at the system level through adherence to safety and operational standards and comparison to predicate devices.

7. The Type of Ground Truth Used

Not applicable in the context of a new diagnostic algorithm. The "ground truth" implicitly referred to is the established safety and performance of predicate ultrasound systems and compliance with international and national safety standards.

8. The Sample Size for the Training Set

Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set.

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

Not applicable for the reasons mentioned above.

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The DUS-3000/DUS-3000Plus 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-3000/DUS-3000Plus 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); Transrectal and Transvaginal.

The DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic BMV 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 the 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, micro convex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10MHz. The system consists of a main unit, a display and transducers.

This document is a 510(k) summary for the DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and outlining the intended uses.

Based on the provided text, there is no detailed information regarding acceptance criteria, specific device performance metrics for a study, or a study that proves the device meets specific acceptance criteria related to diagnostic accuracy.

The summary states: "Clinical testing is not required" and focuses on non-clinical tests for safety standards and comparison to a predicate device to establish substantial equivalence. Therefore, many of the requested details about a performance study with acceptance criteria cannot be extracted from this document.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative or qualitative acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are mentioned for the device. The document states that "clinical testing is not required" and instead relies on non-clinical testing for safety and demonstrating substantial equivalence to a predicate device.

The reported device "performance" is implicitly its adherence to various safety and general characteristics, as it is found substantially equivalent to the predicate.

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

• Sample Size (Test Set): Not applicable, as no clinical performance study was conducted.
• Data Provenance: Not applicable.

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

• Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical performance study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm. It is a "Track 1 device" meaning it's a conventional medical device, not an AI/ML software as a medical device.

7. The Type of Ground Truth Used

• Not applicable, as no clinical performance study was conducted. The "ground truth" for the submission's claims is adherence to safety standards and demonstration of substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

• Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

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