The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CNV mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria or quantitative device performance metrics for image quality or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards.
The "performance" is implicitly deemed acceptable because the device's modifications and new features are found to be "substantially equivalent" to predicate devices, and the system conforms to various medical safety standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit quantitative acceptance criteria for diagnostic performance are stated in the provided summary. | The device (DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System) with its newly added transducers and software options is deemed "substantially equivalent" to predicate devices. This implies that its performance is comparable to already cleared devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "8. Clinical Tests: Not Applicable."
This indicates that no clinical performance study, and therefore no test set with a specific sample size or data provenance, was conducted or submitted as part of this 510(k) notification for the modified device. The claim of substantial equivalence is based on non-clinical tests and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical tests were performed, there was no test set for which ground truth was established by experts.
4. Adjudication Method for the Test Set
As no clinical tests were performed, there was no test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as indicated by "Clinical Tests: Not Applicable." The submission relies on demonstrating substantial equivalence to predicate devices rather than a comparative study against human readers or other devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. The submission focuses on the safety and effectiveness of the system and its components, not an AI algorithm performing a standalone diagnostic task. Even if there were AI-powered features (like the 'Smart NT' or 'Smart Volume' features being newly added), the document does not detail any standalone performance evaluation for these features separate from the overall system.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Since no clinical tests were performed, there was no ground truth established for a test set. The substantial equivalence argument relies on the established safety and performance of predicate devices and general compliance with standards.
8. Sample Size for the Training Set
The document states: "8. Clinical Tests: Not Applicable."
This implies that there was no training set, as no clinical study was conducted. Even if some of the "newly added software options" (like Smart Volume, Smart NT, Tissue Tracking QA, UltraView) incorporate algorithms that would typically require training data, information regarding such training data (size, how ground truth was established, etc.) is not provided in this 510(k) summary. The submission focuses on the substantial equivalence of the overall system and its features to predicate devices, rather than detailing the internal validation of each new software component.
9. How the Ground Truth for the Training Set Was Established
Since no specific training set is mentioned or implied to be part of the 510(k) submission, there is no information provided on how ground truth for a training set was established.
§ 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.