(15 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
The provided document is a 510(k) Pre-Market Notification for the ACUSON CV70™ Cardiovascular System, submitted by Siemens Medical Solutions USA, Inc. in 2004. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new medical device claiming specific performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on:
- Substantial Equivalence: Comparing the ACUSON CV70™ to previously cleared predicate devices (K032111 and K041319) based on intended use, technological characteristics, and safety standards.
- Intended Uses: Listing the clinical applications for which the system, and various transducers, are intended (e.g., Abdominal, Cardiac, Vascular imaging).
- Safety Standards: Demonstrating compliance with various safety and EMC standards (e.g., UL 2601-1, CSA C22.2 No. 601-1, IEC 60601-1, AIUM/NEMA standards for acoustic output, ISO 10993 for biocompatibility).
- Device Description: Describing the system's general function (acquiring and displaying ultrasound echo data in various modes).
Key reasons why the requested information is not present:
- 510(k) Pathway: The 510(k) pathway is primarily about demonstrating substantial equivalence, not about proving clinical effectiveness or performance against pre-defined acceptance criteria through a de novo clinical study. Clinical trials with specified endpoints and performance metrics are more common for PMA (Pre-Market Approval) submissions or sometimes for De Novo classifications, or if there's a significant change in intended use or technology that doesn't fit within an existing predicate.
- Device Type: Diagnostic ultrasound systems are generally well-established technology. The submission is for a "general purpose, mobile, software-controlled, diagnostic ultrasound system." The performance of such systems is often evaluated against established standards and through general validation (e.g., image quality assessment, measurement accuracy), rather than through specific, quantifiable acceptance criteria on a clinical dataset with AI-like metrics (sensitivity, specificity).
- Timing: This submission is from 2004, prior to the widespread adoption of AI/ML in medical devices, which typically requires more rigorous performance validation against ground truth and specific acceptance criteria. The document makes no mention of AI or machine learning components.
Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set ground truth because this information is not included in the provided 510(k) summary.
The tables provided in the document list the intended uses for each transducer and the available imaging modes, explicitly stating whether these indications were "previously cleared by FDA (K032111)" (P) or "added under Appendix E" (E) or are "new indications" (N). This is a demonstration of equivalence, not performance against acceptance criteria.
The "acceptance criteria" in this context refer to compliance with safety standards and substantial equivalence to predicate devices for the stated intended uses. The "study" proving this is the 510(k) submission itself, which details this equivalence and compliance.
§ 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.