(55 days)
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: ultrasound scanner and transducers for B. Tissue and Contrast Harmonic Imaging, M. PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BK Medical Ultrasound Scanner System bk2300:
Based on the provided FDA 510(k) summary (K152052), there is no specific table of acceptance criteria and reported device performance defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application (e.g., detecting a disease) as would be typical for an AI/CADe device.
Instead, this submission is for a general-purpose ultrasound scanner system. The "acceptance criteria" discussed are primarily related to engineering performance, safety, and substantial equivalence to a predicate device as required for a 510(k) clearance, rather than a clinical study evaluating diagnostic performance against specific benchmarks.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not present "acceptance criteria" in the context of diagnostic performance metrics for a specific clinical task. The "performance" described is largely about meeting safety standards and functional capabilities.
| Acceptance Criteria Category (Implied by 510(k) Process) | Stated Performance / Compliance |
|---|---|
| Functional Capabilities (Modes) | Capable of B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging, combined mode imaging, and Elastography. Signal Analysis, Guidance of biopsy needles, geometrical measurements and calculation of parameters, 3-D unit for reconstruction, Optional Vector Flow Imaging (VFI) module for axial and transverse velocity. |
| Acoustic Output Safety | System assures acoustic output stays below pre-amendments upper limits: Ispta |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.