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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 M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.

M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a 510(k) summary provided by Mindray. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria through a clinical study.

The document details:

• Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
• Regulatory Classification: Class II, Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570).
• Intended Use: General diagnostic ultrasound imaging for various applications (fetal, abdominal, intra-operative, small organ, neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology exams) across different patient populations.
• Comparison to Predicate Devices: Lists several Mindray ultrasound systems (M7, M5, DC-70, DC-8, M9) and states that the new device has "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 devices."
• Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and conformance with various medical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1).

It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance data.
7. Details on the type of ground truth used (expert consensus, pathology, outcomes data).
8. Information on how ground truth for training data was established.

This document serves as a regulatory clearance for a traditional medical device (ultrasound system), not an AI/ML-driven device that typically requires detailed clinical performance studies and acceptance criteria as outlined in your prompt.

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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 DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

The provided text is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. It is a declaration of substantial equivalence to previously cleared devices, rather than a study outlining acceptance criteria and device performance. As such, the input does not contain the information needed to directly answer all parts of your request.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission does not typically include a table of acceptance criteria or quantitative performance metrics from a specific study designed to prove the device meets these criteria. Instead, it asserts equivalence based on technological characteristics and adherence to safety standards.

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

No studies with a "test set" are described, nor is there information about sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) relies on comparison to existing predicate devices and compliance with recognized standards.

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

Since no specific study evaluating the device's diagnostic performance against a ground truth is described, there is no information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as no specific test set-based study is presented.

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

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on establishing substantial equivalence based on technological characteristics and adherence to safety standards, not on demonstrating improved human reader performance with AI assistance.

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

This device is a general-purpose diagnostic ultrasound system, not an AI-powered algorithm. Therefore, a standalone algorithm-only study is not applicable and not mentioned. The declaration is for the complete ultrasound system.

7. The Type of Ground Truth Used:

No ground truth is mentioned as no specific diagnostic performance study is presented. The "ground truth" in a 510(k) for a general ultrasound system is typically considered to be compliance with established safety and performance standards for diagnostic ultrasound and equivalence to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a traditional ultrasound system, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as (8).

Summary of available information from the document:

• Acceptance Criteria/Performance: The submission claims the device "has been found to conform with applicable medical safety standards" (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304) and is "substantially equivalent" to predicate devices (Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991)). This implies that the 'acceptance criteria' are primarily regulatory compliance and demonstration of equivalence to existing devices.
• Study Design: This is a 510(k) summary, which is a regulatory submission asserting substantial equivalence, not reporting a clinical study with detailed performance metrics. It does not describe a clinical study in the format one might expect for device performance evaluation against specific metrics.
• Intended Use: The device is broadly applicable for adults, pregnant women, pediatric patients, and neonates for various exams including gynecology, obstetrics, abdominal, cardiac, vascular, and small parts.
• Transducers: A list of compatible transducers (3C5A, 6C2, 7L5, 6CV1, 6LE7, 7LT4, 7L4A, 6LB7, D6-2, 7L6, 3C1, 10L4, 2P2) is provided, each with specific "Indications for Use" forms detailing the clinical applications and modes of operation they support. "P" indicates previously cleared by FDA for that application/mode.

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