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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 fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-3T is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.c. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a diagnostic ultrasound system (Mindray DC-3/DC-3T).

The document focuses on:

• Device Description: General purpose, mobile, software-controlled ultrasonic diagnostic system with various imaging modes (B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode, combined modes).
• Intended Use: Specifies applicable patient populations (adults, pregnant women, pediatric, neonates) and exam types (fetal-OB/GYN, abdominal, pediatric, small parts, neonatal cephalic, transvaginal, transrectal, peripheral vascular, musculoskeletal).
• Safety Considerations: Compliance with FDA guidance for Track 3 devices, acoustic output measurement standards (NEMA UD 2, NEMA UD 3), and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1).
• Substantial Equivalence: A statement that the device is as safe and effective as legally marketed predicate devices (Mindray M5, Mindray DC-6).
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence and lists the transducers included.
• Indications for Use Forms: Detail the specific clinical applications and modes of operation for the main system and each transducer (3C5A, 6CV1, 7L4A, 7L6, 10L4).

Missing Information:

The document does not provide the following information that would be necessary to answer the prompt:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution) or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No performance study data is presented, so no information on test set size or its origin.
3. Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described for a performance study.
4. Adjudication method for the test set: Not applicable as no performance study is detailed.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information: No such study is mentioned.
6. Standalone (algorithm only) performance study information: Not applicable as this is a complete ultrasound system, not an AI algorithm with standalone performance.
7. Type of ground truth used: Not applicable as no performance study is detailed.
8. Sample size for the training set: Not applicable as no data training is described for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence to existing devices through safety and intended use considerations, rather than reporting on a specific performance study with acceptance criteria.

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