The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a 510(k) summary provided by Mindray. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria through a clinical study.
The document details:
- Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
- Regulatory Classification: Class II, Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570).
- Intended Use: General diagnostic ultrasound imaging for various applications (fetal, abdominal, intra-operative, small organ, neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology exams) across different patient populations.
- Comparison to Predicate Devices: Lists several Mindray ultrasound systems (M7, M5, DC-70, DC-8, M9) and states that the new device has "the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
- Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and conformance with various medical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1).
It does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone algorithm performance data.
- Details on the type of ground truth used (expert consensus, pathology, outcomes data).
- Information on how ground truth for training data was established.
This document serves as a regulatory clearance for a traditional medical device (ultrasound system), not an AI/ML-driven device that typically requires detailed clinical performance studies and acceptance criteria as outlined in your prompt.
§ 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.