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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, urology and transesophageal (Cardiac) 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 is a 510(k) premarket notification for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel claims through extensive clinical trials. Therefore, much of the information you requested about acceptance criteria and detailed study results for performance validation (like sample sizes, expert qualifications, and ground truth establishment) is not present in the provided text, as it's not typically required for this type of submission.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics in the format of a table. Instead, it attests to the device's compliance with established safety and performance standards, and its substantial equivalence to predicate devices.

Acceptance Criteria (Implied from the document):

• Compliance with recognized medical device safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, UD 2, UD 3, ISO 10993-1).
• Acoustic power levels below FDA limits.
• Biocompatibility of patient-contact materials (for new transducers).
• Effectiveness of cleaning and disinfection.
• Thermal, electrical, and mechanical safety.
• Software life cycle processes compliance (IEC 62304).
• Usability engineering application (IEC 62366 and IEC 60601-1-6).
• Application of risk management (ISO 14971).
• Identical intended uses and basic operating modes compared to predicate devices.

Reported Device Performance (Implied):
The device is stated to conform with all the above-mentioned applicable standards and to have identical intended uses and basic operating modes as the predicate devices. The modifications and newly added features (new transducers, software options, contrast imaging function) have been compared with predicate devices and found to be "substantially equivalent."

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

The document does not specify a sample size for a test set or data provenance from patient studies. The review is based on non-clinical testing and comparison to predicate devices.

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

Not applicable for this type of submission. Ground truth, in the context of clinical performance evaluation with expert readers, is not detailed as this submission relies on non-clinical testing and established equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with 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 study was not conducted or mentioned, as this is a traditional ultrasound system and not an AI-assisted diagnostic device seeking to demonstrate improved reader performance.

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 algorithm being submitted for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly established by compliance with recognized industry standards for acoustic output, electrical safety, biocompatibility, and software quality, as well as demonstrated equivalence to predicate devices which have already established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

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