(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), urology, peripheral vascular, intraoperative, pediatric, cephalic, fetal, transrectal, transvaginal, neonatal musculoskeletal (general and superficial).
The DP-6900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode or the combined mode (i.e. B/M Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System. It describes the device's intended use and safety considerations, but does not contain information about explicit acceptance criteria or a study proving the device meets those criteria in terms of diagnostic performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and acoustic output measurements. It lists various transducers and their clinical applications, indicating which modes (B, M, Combined) are available for each application and whether "Tissue Harmonic Imaging" is an option. However, these tables do not represent performance metrics against acceptance criteria.
Therefore, many of the requested information points cannot be extracted from the given text.
Here is a breakdown of what can and cannot be answered based on the provided input:
| Section | Information from Text |
|---|---|
| 1. Table of acceptance criteria and reported device performance | No explicit acceptance criteria or reported device performance metrics are provided in the document. The document states: "The conclusions drawn from testing of the DP-6900 Digital Ultrasonic Diagnostic Imaging System demonstrate that the device is as safe and effective as the legally marketed predicate devices." This is a general statement of equivalency, not a presentation of performance data against specific acceptance criteria. The tables provided (Pages 4-13) indicate the clinical applications and imaging modes supported by various transducers, not performance data. For example, for the DP-6900 system (Page 4), for "Fetal" application, B and M modes, and a combined mode are marked as "N" (new indication), and "Note 1" refers to Tissue Harmonic Imaging. This describes functionality, not performance. |
| 2. Sample size and data provenance for the test set | Not provided. The document does not mention any clinical study with a test set. |
| 3. Number and qualifications of experts for ground truth | Not provided. As no clinical study or ground truth establishment is mentioned, this information is absent. |
| 4. Adjudication method for the test set | Not provided. |
| 5. MRMC comparative effectiveness study | No. The document does not describe any MRMC comparative effectiveness study or human reader improvement with AI assistance. This device is an ultrasound system, and the document focuses on its substantial equivalence to predicate ultrasound systems, not on AI-driven diagnostic assistance. |
| 6. Standalone (algorithm only) performance study | No. This document describes an ultrasound imaging system, not an algorithm with standalone performance. |
| 7. Type of ground truth used | Not provided. Since no clinical performance study is detailed, the type of ground truth is not mentioned. The safety and effectiveness claims are based on compliance with standards (e.g., NEMA UD 2: 2004 for acoustic output) and substantial equivalence to previously cleared predicate devices. |
| 8. Sample size for the training set | Not applicable. This device is a diagnostic ultrasound system; there is no mention of an AI model or a training set in the context of diagnostic performance. |
| 9. How ground truth for the training set was established | Not applicable. |
In summary, the provided 510(k) summary for the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with recognized safety standards, rather than presenting clinical performance data against specific acceptance criteria.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.