The DC-40/DC-35/DC-40S/DC-40 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic.adult.cephalic.trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower mode, THI Mode, 3D/4D Mode, iScape mode, TDI mode, Color M mode, Biospy Guidance, Elastography, Contrast imaging (Liver) 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, Phased array and convex array.
This document is an FDA 510(k) summary for a Diagnostic Ultrasound System (DC-40/DC-35/DC-45/DC-40S/DC-40 Pro). The information provided focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, many of the requested categories in your prompt are Not Applicable (N/A) based on the provided text, as this submission is for an ultrasound system, not an AI/CADe device requiring performance metrics.
Here's the breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria for the device performance in terms of diagnostic effectiveness for specific clinical tasks, as it's a general ultrasound system and not an AI or CADe device. Instead, it demonstrates compliance with regulatory standards for safety and fundamental performance.
| Acceptance Criteria Category | Device Performance (Based on provided text) |
|---|---|
| Acoustic Output | Below the limits of FDA |
| Biocompatibility | Transducers and needle-guided brackets tested under ISO 10993-1 |
| Cleaning and Disinfection | Effectiveness evaluated |
| Electrical Safety | Complies with ANSI/AAMI ES60601-1 and related standards |
| Mechanical Safety | Complies with ANSI/AAMI ES60601-1 and related standards |
| Software Life Cycle | Complies with IEC 62304 |
| Usability (Human Factors) | Complies with IEC 62366-1 and IEC 60601-1-6 |
| Risk Management | Complies with ISO 14971 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. The document refers to non-clinical tests (e.g., electrical safety, acoustic output), not performance data from a patient test set for diagnostic accuracy.
- Data Provenance: Not applicable. The tests were compliance-based rather than data-driven from patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This information is relevant for studies validating diagnostic algorithms against ground truth established by medical experts (e.g., radiologists, pathologists). The provided document describes the clearance of an ultrasound system, not an AI/CADe product.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no human reader study or test set requiring adjudication of ground truth is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted device. The submission is for a diagnostic ultrasound system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm but a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context refers to compliance with established engineering and safety standards, rather than medical diagnostic ground truth.
8. The sample size for the training set:
Not applicable. This device is not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model described.
In summary: The provided document is a 510(k) summary for a general-purpose diagnostic ultrasound system. It details the device's intended use, modifications from a predicate device, and compliance with various recognized safety and performance standards. It explicitly states, "Clinical Tests: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." Therefore, the type of performance data and studies requested in your prompt (which are typical for AI/CADe devices) are not included in this document.
§ 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.