(90 days)
The LinkQuest Diagnostic Ultrasound SQ860 is intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients and neonates. It is intended for use by or on the order of a physician or similarly qualified health care professional in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
The LinkQuest Diagnostic Ultrasound System SQ860 is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color-Mode, PW-Mode, TDI mode, CW mode, 3D/4D mode, Elastography (Strain imaging) and/or the combined modes. This system is a Track 3 device that employs a set of probes that include linear array, convex array, Intracavity array, phased array and 4D array with a frequency range of approximately 2 MHz to 10.0 MHz.
The provided text does not contain information about specific acceptance criteria, reported device performance, or a study design involving a test set, experts, or ground truth.
The document is a 510(k) premarket notification letter from the FDA regarding the LinkQuest Diagnostic Ultrasound System model SQ860. It primarily focuses on:
- Indications for Use: Listing the various clinical applications and modes of operation for the device and its different transducers.
- Device Description: A general overview of the ultrasound system's capabilities.
- Predicate Devices: Identifying an equivalent device already on the market (Ultrasonics Touch and SonoSite maxx).
- Non-clinical Tests: Listing the safety standards and regulations the device complies with (IEC, ISO, NEMA, AIUM).
- Substantial Equivalence Determination: Concluding that the device is substantially equivalent to predicate devices based on technical characteristics and performance tests (without detailing those tests).
- Clinical Test: Explicitly stating "Clinical testing is not required."
Therefore, I cannot provide the requested information regarding:
- a table of acceptance criteria and reported device performance,
- sample size used for the test set or data provenance,
- number of experts, their qualifications, or adjudication method for ground truth,
- MRMC comparative effectiveness study or its effect size,
- standalone performance study,
- type of ground truth used (beyond implying compliance with relevant standards),
- sample size for the training set, or
- how the ground truth for the training set was established.
The document indicates that substantial equivalence was determined based on non-clinical tests and comparison to predicate devices, rather than a clinical study with a defined test set and ground truth.
§ 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.