(244 days)
The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following The Modified Beeral Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, apprications: Contral News Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications. The system supports the Superilean Massantanteretalters for Use tables, including the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.
The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.
The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
- AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
- l 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment L
- . EN/IEC 60601-1
- 8 EN/IEC 60601-1-1
- B EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power .
- . ISO 10993-1 Biocompatibility
The provided text describes the Acuson S2000 ABVS Ultrasound System and its 510(k) submission, focusing primarily on its intended use and substantial equivalence to predicate devices, as well as listing safety standards it meets and the transducers supported. However, it does not contain any information regarding specific acceptance criteria, study designs to prove device performance against acceptance criteria, or any performance data (such as accuracy, sensitivity, specificity, or reader studies).
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document states:
- "The S2000 modifications are verified and validated according to the company's design control process." (Section E. Performance Data)
This indicates that internal verification and validation were performed, but the details of these tests, including acceptance criteria and results, are not present in the provided FDA submission summary.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.