(9 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 text is a 510(k) summary for the ACUSON CV70 Cardiovascular System, a diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and safety standards. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical evaluation.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or detailed device performance metrics from a study.
- Sample size used for the test set and the data provenance: There is no mention of a test set or clinical study data. The document focuses on regulatory compliance and device description.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set or ground truth establishment is described, this information is not present.
- Adjudication method for the test set: No test set means no adjudication method is discussed.
- 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: There is no indication of any MRMC study or AI assistance capability for this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as a diagnostic ultrasound system with various imaging modes, implying human operation, not a standalone algorithm.
- The type of ground truth used: No ground truth is mentioned.
- The sample size for the training set: There is no mention of a training set as no machine learning/AI component is described.
- How the ground truth for the training set was established: Not applicable, as no training set is mentioned.
Summary of what the document does provide regarding the device validation:
The document primarily establishes the device's substantial equivalence to previously cleared predicate devices (SONOLINE G50 & G60 S, and ACUSON Sequoia) by comparing its technological characteristics and intended uses. It also lists the product safety standards the device has been designed to meet (UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, ISO 10993).
The FDA's clearance letter requests a "postclearance special report" containing "complete information, including acoustic output measurements based on production line devices." This indicates that performance data (specifically acoustic output) would be collected post-clearance to confirm safety, but it's not a pre-market study establishing efficacy or meeting performance criteria in the way your questions imply.
§ 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.