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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-40/DC-35/DC-45/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(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, 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 3 MHz to 10.0MHz.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that clinical studies were not required or performed to demonstrate substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria based on clinical performance data is not detailed in this document.

The acceptance criteria mentioned are general safety and performance standards rather than specific clinical performance metrics. The document instead focuses on demonstrating that the new device is substantially equivalent to previously cleared devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, with a clear indication when the information is not present or not applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission asserting substantial equivalence based on non-clinical testing and comparison to predicates, the "acceptance criteria" are compliance with recognized standards and similarity to predicate devices. Specific performance metrics (e.g., sensitivity, specificity for a particular clinical task) are not provided as acceptance criteria for this type of submission.

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

• Not applicable for clinical performance data. The submission states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
• For non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.), the sample sizes are not specified in this summary. Data provenance would be from internal lab testing conducted by 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. No clinical test set with ground truth established by experts is mentioned in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable. No clinical test set and thus no adjudication method 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, an MRMC comparative effectiveness study was not done. The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a Diagnostic Ultrasound System, not an AI-assisted diagnostic tool that would typically undergo such studies.

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

• Not applicable. This device is a diagnostic ultrasound system; performance is inherently "human-in-the-loop" as it requires a trained operator to acquire and interpret images. There is no mention of a standalone algorithm's performance.

7. The type of ground truth used

• Not applicable for clinical performance. For non-clinical tests (e.g., electrical safety, acoustic output), ground truth is established by recognized standards and calibrated measurement equipment.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" for an algorithm, as this is a diagnostic ultrasound imaging system, not an AI/ML-based diagnostic device in the context of this submission.

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

• Not applicable. No training set for an algorithm is mentioned.

In summary, this 510(k) submission establishes substantial equivalence for a diagnostic ultrasound system primarily through a comparison to predicate devices and adherence to recognized non-clinical safety and performance standards. It does not involve clinical performance studies with specific acceptance criteria, test sets, expert ground truth, or AI algorithm validation.

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