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The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-31 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, Color mode, PW mode, PW mode, Power mode, DirPower mode 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 2.0 MHz to 12.0 MHz.

The provided text is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. It is a declaration of substantial equivalence to previously cleared devices, rather than a study outlining acceptance criteria and device performance. As such, the input does not contain the information needed to directly answer all parts of your request.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission does not typically include a table of acceptance criteria or quantitative performance metrics from a specific study designed to prove the device meets these criteria. Instead, it asserts equivalence based on technological characteristics and adherence to safety standards.

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

No studies with a "test set" are described, nor is there information about sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) relies on comparison to existing predicate devices and compliance with recognized standards.

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

Since no specific study evaluating the device's diagnostic performance against a ground truth is described, there is no information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as no specific test set-based study is presented.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on establishing substantial equivalence based on technological characteristics and adherence to safety standards, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This device is a general-purpose diagnostic ultrasound system, not an AI-powered algorithm. Therefore, a standalone algorithm-only study is not applicable and not mentioned. The declaration is for the complete ultrasound system.

7. The Type of Ground Truth Used:

No ground truth is mentioned as no specific diagnostic performance study is presented. The "ground truth" in a 510(k) for a general ultrasound system is typically considered to be compliance with established safety and performance standards for diagnostic ultrasound and equivalence to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a traditional ultrasound system, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as (8).

Summary of available information from the document:

• Acceptance Criteria/Performance: The submission claims the device "has been found to conform with applicable medical safety standards" (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304) and is "substantially equivalent" to predicate devices (Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991)). This implies that the 'acceptance criteria' are primarily regulatory compliance and demonstration of equivalence to existing devices.
• Study Design: This is a 510(k) summary, which is a regulatory submission asserting substantial equivalence, not reporting a clinical study with detailed performance metrics. It does not describe a clinical study in the format one might expect for device performance evaluation against specific metrics.
• Intended Use: The device is broadly applicable for adults, pregnant women, pediatric patients, and neonates for various exams including gynecology, obstetrics, abdominal, cardiac, vascular, and small parts.
• Transducers: A list of compatible transducers (3C5A, 6C2, 7L5, 6CV1, 6LE7, 7LT4, 7L4A, 6LB7, D6-2, 7L6, 3C1, 10L4, 2P2) is provided, each with specific "Indications for Use" forms detailing the clinical applications and modes of operation they support. "P" indicates previously cleared by FDA for that application/mode.

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