(160 days)
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the InnoSight diagnostic ultrasound:
- 64 Channel all digital beam former .
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native frequency digital scan converter
- InnoSight diagnostic ultrasound can be hand carried for portable use
- Remote access image management through LAN port
- Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm performance perspective. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, safety considerations, and general technical specifications of an ultrasound system.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as they are not present in the given text.
The "Predicate Device Comparison" table lists various technical specifications and operating controls for the submitted device (InnoSight Diagnostic Ultrasound System) and two predicate devices (BenQ UP600 and Philips CX50 and Sparq). This comparison is used to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing or proving specific performance acceptance criteria for a new, AI-driven functionality.
§ 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.