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Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.

This device is a general purpose diamostic ultrasound system intended for use by qualified and trained healtheare 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(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.

However, I can extract information related to the device's broader regulatory and non-clinical testing.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."

However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.

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

Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.

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 human expert ground truth was established for a test set, as no clinical study is presented.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or ground truth was established that would require 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

Not applicable/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.

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

Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.

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

Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.

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

Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.

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The DC-40/DC-35/DC-40S/DC-40 Pro 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 cephalic.adult.cephalic.trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower mode, THI Mode, 3D/4D Mode, iScape mode, TDI mode, Color M mode, Biospy Guidance, Elastography, Contrast imaging (Liver) 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, Phased array and convex array.

This document is an FDA 510(k) summary for a Diagnostic Ultrasound System (DC-40/DC-35/DC-45/DC-40S/DC-40 Pro). The information provided focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested categories in your prompt are Not Applicable (N/A) based on the provided text, as this submission is for an ultrasound system, not an AI/CADe device requiring performance metrics.

Here's the breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria for the device performance in terms of diagnostic effectiveness for specific clinical tasks, as it's a general ultrasound system and not an AI or CADe device. Instead, it demonstrates compliance with regulatory standards for safety and fundamental performance.

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

• Sample Size: Not applicable. The document refers to non-clinical tests (e.g., electrical safety, acoustic output), not performance data from a patient test set for diagnostic accuracy.
• Data Provenance: Not applicable. The tests were compliance-based rather than data-driven from patient cases.

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. This information is relevant for studies validating diagnostic algorithms against ground truth established by medical experts (e.g., radiologists, pathologists). The provided document describes the clearance of an ultrasound system, not an AI/CADe product.

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

Not applicable, as no human reader study or test set requiring adjudication of ground truth 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. This is not an AI-assisted device. The submission is for a diagnostic ultrasound system.

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

Not applicable. This is not an AI algorithm but a diagnostic ultrasound system.

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

Not applicable. The "ground truth" in this context refers to compliance with established engineering and safety standards, rather than medical diagnostic ground truth.

8. The sample size for the training set:

Not applicable. This device is not an AI/Machine Learning model that requires a training set.

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

Not applicable, as there is no training set for an AI/ML model described.

In summary: The provided document is a 510(k) summary for a general-purpose diagnostic ultrasound system. It details the device's intended use, modifications from a predicate device, and compliance with various recognized safety and performance standards. It explicitly states, "Clinical Tests: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." Therefore, the type of performance data and studies requested in your prompt (which are typical for AI/CADe devices) are not included in this document.

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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.

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