(89 days)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HERA W10 is general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode. M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W10 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
I am sorry, but the provided text does not contain sufficient information to answer your request. The document is a 510(k) summary for the HERA W10 Diagnostic Ultrasound System, which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended uses and compliance with safety standards.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes used for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set or how its ground truth was established.
In fact, section 11 explicitly states: "The subject of this premarket submission, HERA W10, did not require clinical studies to support substantial equivalence." This indicates that detailed performance studies as you've requested were not part of this specific FDA submission.
§ 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.