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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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D mode, 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 10.0 MHz.

This document describes a 510(k) premarket notification for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This type of submission is a statement to the FDA that the device is substantially equivalent to another legally marketed device, not a claim of superior performance or a detailed study of acceptance criteria against novel performance metrics.

Therefore, the provided text does not contain the acceptance criteria or a study proving the device meets those criteria in the context of specific performance metrics for diagnosis or improved human reader performance with AI assistance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards.

Here's an analysis of the provided information relative to your requested points:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with recognized safety and performance standards, rather than defining specific outcome-based acceptance criteria and reporting performance against them.

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

This information is not provided as there is no clinical performance study detailed in this 510(k) summary. The document states "DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety." These are non-clinical hardware tests, not clinical performance studies involving 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 (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided. As no clinical performance study is detailed, there's no mention of a test set, ground truth establishment, or experts for that purpose.

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

This information is not applicable/not provided. No clinical performance study or test set requiring adjudication 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

An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this document. The device is a general-purpose diagnostic ultrasound system, not explicitly an AI-powered diagnostic tool. The purpose of this 510(k) is to establish substantial equivalence, not to demonstrate improved human reader performance.

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

This information is not applicable/not provided. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.

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

This information is not applicable/not provided. Since no clinical performance study with a test set is detailed, there's no mention of the type of ground truth used.

8. The sample size for the training set

This information is not applicable/not provided. The device is an ultrasound system. There is no mention of a "training set" in the context of an algorithm or AI.

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

This information is not applicable/not provided. As there's no training set mentioned in the context of an algorithm or AI, there's no corresponding information on how ground truth would be established for it.

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