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510(k) Data Aggregation
(45 days)
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.
The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance 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, Convex array probe. The software of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is based on the main predicate DP-50, and it has a Moderate level of concern.
This is a 510(k) premarket notification for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System. The submission claims substantial equivalence to predicate devices, primarily the DP-50 Digital Ultrasonic Diagnostic Imaging System (K111435).
The document focuses on demonstrating substantial equivalence rather than presenting formal acceptance criteria with specific performance metrics for a new AI/algorithm. However, it implicitly defines acceptance based on the equivalence of its features and performance to predicate devices.
Here's an analysis of the provided information, focusing on aspects relevant to AI/algorithm performance if new features were indeed algorithm-driven. The new features such as "Smart 3D", "Smart Face", "Smart OB", "Smart Bladder", and "iNeedle" suggest the presence of algorithms or AI components.
Since this is a 510(k) premarket notification, formal "acceptance criteria" and detailed "study results" in the typical sense of a clinical trial for breakthrough devices demonstrating specific performance metrics are often replaced by comparisons to predicate devices and adherence to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission primarily relying on substantial equivalence, explicit quantitative acceptance criteria for each individual "smart" feature (e.g., Smart Face, Smart OB) are not provided in the document in the format of a clinical study. Instead, acceptance is implied by demonstrating that the performance and technological characteristics of the new features are the same as or comparable to those already cleared in predicate devices. The "S/D" column indicates if the feature is "Same" or "Different" from the predicate. For those marked "S" (Same), the implied acceptance criterion is "performance identical to the predicate device."
Here's an interpretation based on the provided comparative tables for the "new added special functions":
| Feature Category | Feature Name | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Imaging Modes & Features | 4D | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides 4D function with real-time 3D image rendering, same as Resona 7. |
| Smart 3D | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides Smart 3D function with manual probe movement and automatic 3D rendering, same as Resona 7. | |
| Free Xros M | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Allows manipulation of M-mark line at desired angles in 2D modes (B, Color, Power), same as Resona 7. | |
| iLive | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides enhanced imaging experience with light rendering effect, global and partial scattering modes, same as Resona 7. | |
| iWorks | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides step-by-step workflow protocols to reduce operations and keystrokes, same as Resona 7. | |
| iScape View | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides panoramic imaging by piecing together B images for extended views, same as Resona 7. | |
| iNeedle | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Makes needle display clearer during biopsy/anesthesia via additional deflection transmission, same as Resona 7. | |
| iPage | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides a "Visualization" mode for displaying sectional images as parallel slices, same as Resona 7. | |
| HPRF | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Enhances the range of detecting high-velocity flow when velocities exceed processing capabilities or depth for PW Doppler scale, same as Resona 7. | |
| Smart Face | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Automatically recognizes fetal face and displays it at a recommended viewing angle, same as Resona 7. | |
| Smart OB | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides obstetric measurement tools for calculating obstetric measurements, same as Resona 7. | |
| Smart Bladder | Technological characteristics and function are the same as predicate (DC-N3, K140030). | Measures the volume of urine in the bladder automatically, same as DC-N3. | |
| New Imaging Modes (Transducers) | PW mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Provides blood flow velocity and direction in real-time spectral display, same as DC-N2. |
| Color mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Detects color flow information to judge direction and speed of blood flow, same as DC-N2. | |
| Power mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Provides non-directional display of blood flow intensity and DirPower for flow direction, same as DC-N2. | |
| Acoustic Output | Ispta.3 |
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