(85 days)
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIO P10, LOGIO P9 and LOGIO P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.
The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display.
The provided text describes a 510(k) premarket notification for the LOGIQ P10, LOGIQ P9, and LOGIQ P8 diagnostic ultrasound systems. It details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, the document explicitly states in "Summary of Clinical Tests" that "The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was conducted or reported in this 510(k) submission.
The document focuses on demonstrating substantial equivalence through:
- Comparison to Predicate Devices: Showing the new devices use the same fundamental scientific technology, have the same clinical intended uses (with minor additions), similar imaging modes (with some new modes migrated from other cleared devices like UGAP), and similar capabilities for measurements, image capture, review, and reporting.
- Non-Clinical Tests: Verifying acoustic output, biocompatibility, cleaning and disinfection effectiveness, and compliance with thermal, electrical, electromagnetic, and mechanical safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2016) DICOM Set, IEC 62359).
- Quality Assurance Measures: Including risk analysis, requirements reviews, design reviews, unit level testing, integration testing, performance testing, and safety testing.
There is no mention of acceptance criteria based on performance metrics that would typically arise from a clinical study (e.g., sensitivity, specificity, AUC) or any study that evaluated human reader performance with or without AI assistance, as these are not AI/ML-enabled devices described here, but rather general diagnostic ultrasound systems.
§ 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.