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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound 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 and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Reape View, TDI, Color M. Strain Elastography, Contrast imaging (Contrast imaging (Contrast agent for LVO), STE,STQ.

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array. convex array, pencil phased and phased array.

The provided text is a 510(k) Summary for a Diagnostic Ultrasound System, which is a general-purpose diagnostic imaging device. For such devices, the FDA typically relies on non-clinical performance data (e.g., electrical safety, acoustic output, electromagnetic compatibility, software validation) to demonstrate substantial equivalence to a predicate device, rather than clinical studies with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity.

Therefore, the document explicitly states: "8. Clinical Tests: Not Applicable."

This means that the type of study for proving the device meets acceptance criteria, in the context of diagnostic performance metrics, was not performed for this submission. The "acceptance criteria" discussed in the document are primarily related to safety, electrical performance, and adherence to recognized standards, rather than clinical diagnostic efficacy.

Given the information in the provided document, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical tests were "Not Applicable" and no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device's efficacy, a table of diagnostic acceptance criteria and performance cannot be generated from the provided text.

However, the document lists compliance with various regulatory and safety standards, which can be seen as the "acceptance criteria" the device met for its substantial equivalence determination. The "reported device performance" is its demonstration of compliance with these standards and its similarity to the predicate device.

• IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
• IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
• IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes.
• ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
• NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
• AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
• IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
• IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety.
• The device was found to conform with applicable medical safety standards (listed above).
• The acoustic power levels are below FDA limits, similar to the predicate device.
• The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device.
• The device's safety and effectiveness profile is found to be similar to the predicate device. |

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

• Sample Size for Test Set: Not applicable for diagnostic performance as no clinical tests were performed.
• Data Provenance: Not applicable for diagnostic performance. For safety and performance evaluations, the data would typically come from internal engineering and lab testing conducted by the manufacturer (Shenzhen Mindray Bio-Medical Electronics Co., LTD in China).

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

• Not applicable as no clinical tests or diagnostic performance evaluations requiring expert ground truth were conducted or reported in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable as no clinical tests or diagnostic performance evaluations requiring adjudication were conducted or reported 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

• No MRMC comparative effectiveness study was done or reported. This device is a general diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study for 510(k) clearance.

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

• Not applicable. This is a diagnostic ultrasound system, not an standalone algorithm. The device has "Smart" features (e.g., Smart 3D, Smart Planes FH, Smart Pelvic, iClear+), but these are integrated functionalities of the ultrasound system itself, not standalone algorithms requiring separate "algorithm-only" performance evaluation in the context of this 510(k). The regulatory pathway for this device does not necessitate such a study as it's a general-purpose ultrasound.

7. The type of ground truth used

• Not applicable for diagnostic performance metrics, as no clinical efficacy studies were conducted. For the non-clinical tests, the "ground truth" would be the established specifications and limits defined by the international and national standards to which the device was tested for compliance.

8. The sample size for the training set

• Not applicable. This document describes a traditional diagnostic ultrasound system. While it has "Smart" features that likely involve internal algorithms some of which might be trained, the document does not provide details on algorithm training, or a "training set" in the context of a machine learning model submitted for software as a medical device (SaMD) clearance.

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

• Not applicable, as a training set for a machine learning model is not discussed or required for this type of 510(k) submission for a general diagnostic ultrasound system.

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The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) 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, Phased array, Volume and Pencil probe.

Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System.

Important Note: This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness as a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to safety, performance aspects comparable to the predicate, and adherence to relevant standards. Clinical effectiveness studies are explicitly stated as "Not applicable."

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the acceptance criteria are not typically expressed as specific performance metrics (like sensitivity/specificity) for a diagnostic task, but rather as compliance with safety standards and equivalence to predicate devices in terms of intended use and technological characteristics.

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

The submission explicitly states: "8. Clinical Studies Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, there is no mention of a traditional test set of patient data, sample size, or data provenance (country of origin, retrospective/prospective) for proving device performance in a diagnostic context. The assessment relies on engineering and performance testing against standards and comparison to predicate devices.

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

As clinical studies were "Not applicable," there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for diagnostic performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The submission explicitly states no clinical studies were required or performed. There is no mention of AI features (other than "Smart3D", "Smart face", "Smart plane CNS", which are likely imaging enhancement features rather than AI for diagnostic interpretation) that would necessitate a comparative effectiveness study with human readers.

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

Not applicable, as no clinical studies were conducted for diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a 510(k) for an ultrasound system, the "ground truth" for demonstrating substantial equivalence primarily relates to:

• Compliance with recognized standards: The physical and electrical safety, acoustic output, and electromagnetic compatibility are tested against established engineering and medical device standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, ISO 10993-1).
• Performance specifications: The ultrasound system's various modes (B-Mode, M-Mode, etc.) and transducer capabilities are assessed against their defined technical specifications and compared to those of predicate devices.
• Physical and material properties: Biocompatibility, cleaning/disinfection effectiveness are evaluated according to relevant standards.

8. The Sample Size for the Training Set

Not applicable. No AI/ML model requiring a training set is described as the primary subject of the 510(k) for demonstrating substantial equivalence as a diagnostic device. The "Smart" features mentioned are likely integrated software functionalities rather than standalone AI for diagnostic interpretation requiring significant training data submitted for review.

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

Not applicable, as no training set for an AI/ML model for diagnostic interpretation is discussed.

Ask a specific question about this device

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound 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 and adult cephalic, trans-rectal, trans-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape,4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging 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 and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.

This document describes the premarket notification (510(k)) for the Mindray DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System. It is a submission to the FDA for substantial equivalence to legally marketed predicate devices.

The information provided focuses on the technical specifications, intended uses, and compliance with safety standards, rather than a study proving the device meets specific acceptance criteria related to AI performance or diagnostic accuracy in the way described in the prompt's request. Crucially, the document explicitly states that no clinical studies were performed.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain data on AI performance, human reader improvement with AI assistance, or specific acceptance criteria met through clinical trials. It primarily addresses the substantial equivalence of an ultrasound imaging system in terms of its features, safety, and technological characteristics compared to predicate devices.

However, I can extract the information relevant to the device's stated performance and the basis for its acceptance from a regulatory perspective, focusing on the equivalence to existing devices and compliance with safety standards.

Here's an attempt to answer using the provided text, while noting the limitations:

Acceptance Criteria and Device Performance (based on provided text):

The document does not define specific "acceptance criteria" for diagnostic accuracy or AI performance in the traditional sense, nor does it report "device performance" in terms of metrics like sensitivity, specificity, or AUC, as it's a 510(k) submission primarily focused on substantial equivalence (safety and efficacy similar to existing devices). Instead, the acceptance is based on demonstrating the device's technical characteristics, safety, and intended uses are comparable to already cleared predicate devices and comply with relevant standards.

Table of "Acceptance Criteria" (interpreted as demonstrated compliance/equivalence) and "Reported Device Performance" (interpreted as features/capabilities):

Study Details (based on provided text):

1. Sample size used for the test set and the data provenance: Not applicable. The document explicitly states "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." The evaluation relies on non-clinical (engineering, safety, and performance) testing and comparison to predicate devices, not diagnostic performance on a test set of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies or test sets with ground truth were used or are described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies or test sets were used.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Diagnosis) device providing analytical results that would assist human readers in a diagnostic task. The "Smart3D" and "iScape" features mentioned are imaging modes/enhancements, not necessarily AI for diagnostic assistance. There is no mention of such a study or effect size.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI diagnostic algorithm; it's an ultrasound imaging device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies or test sets for diagnostic accuracy were performed or are detailed.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that underwent training on a dataset for a diagnostic task.

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

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence to existing, legally marketed ultrasound devices through non-clinical testing (e.g., electrical safety, acoustic output, biocompatibility, software validation) and detailed comparison of technological characteristics and intended uses. It does not involve AI performance evaluation or clinical studies that would generate data for the specific "acceptance criteria" and "study proving device meets acceptance criteria" as outlined in your prompt for AI/diagnostic accuracy studies.

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