(44 days)
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial), intraoperative and transesophageal(cardiac) exams.
M7/M7T 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 with a frequency range of approximately 2.5 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD M7/M7T Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than providing a detailed study proving performance against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, many of the requested details regarding acceptance criteria, study performance, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this type of regulatory submission for a diagnostic ultrasound system.
Here's an analysis of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm. Instead, it asserts that the device has been "evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and "found to conform with applicable medical safety standards." It lists several IEC and ISO standards that the device is designed to meet.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The submission describes a general-purpose diagnostic ultrasound system, not an AI/algorithm with a test set of data. The "tests" mentioned are non-clinical safety and performance tests for hardware and basic functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a diagnostic algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. The "Q-view software" and "Q-path" mentioned are for digital image storage and remote access, not for AI assistance in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. No ground truth is described in the context of an AI/algorithm for diagnostic performance. The ground truth for evaluating the safety and performance mentioned would be established by standard engineering and medical device testing methodologies.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/algorithm submission.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.