(55 days)
The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel , urology exams.
M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
The provided document is a 510(k) premarket notification for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. M9/M9T/M9CV Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI device.
Therefore, many of the requested details, such as specific acceptance criteria for an AI model's performance (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets for an AI model, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly detailed in this type of submission.
This submission details the indications for use and non-clinical performance tests that confirm the device operates safely and effectively as an ultrasound system, comparing it to existing, legally marketed predicate devices.
Here's a breakdown of the information that can be extracted or inferred from the provided text, related to the nature of the submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for an ultrasound system, the "acceptance criteria" are primarily related to safety, electrical, mechanical, and acoustic performance, and demonstrating that the device functions as intended for its specified clinical applications. The "reported device performance" is essentially that it complies with the referenced standards and is comparable to predicate devices. Specific quantitative performance targets for diagnostic accuracy (like sensitivity/specificity) for a novel AI algorithm detecting conditions are not present here because this is for a general ultrasound system.
| Acceptance Criterion Type | Reported Device Performance (Compliance/Comparison) |
|---|---|
| Intended Use | Applicable for adults, pregnant women, pediatric patients, and neonates. Intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams. (Matches predicate device functionalities). |
| Technological Characteristics | Same as predicate M9/M9 CV/M9T (K141010), comparable in key safety/effectiveness features. All systems transmit ultrasonic energy, perform post-processing for display of anatomic structures and fluid flow. (Comparable to predicate devices). |
| Acoustic Power Level | Below FDA limits. (Complies with FDA regulations). |
| Compliance with Standards | Complies with: UD 2, UD 3, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO14971, ISO 10993-1, IEC 62304. (Meets recognized medical device safety and performance standards). |
| Transducer Compatibility | New transducers (C6-2Gs, L14-6Ws, P7-3s, L10-3s) are substantially equivalent with predicate DC-8 (K150080). |
| Measurements and Calculations | Same capabilities as predicate M9/M9T/M9CV (K141010), with added features (uterine artery's PI and RI growth curve, new CFEF formula in obstetric, Global Strain curve and peak shown increased) confirmed substantially equivalent with predicates Vivid q and Voluson E8. |
| Performance Specification | Same as predicate M9/M9T/M9CV K141010, with added functions (Auto EF, automated scan angle correction for PW, Q-path, MedTouch support) confirmed substantially equivalent with predicates Vivid q, DC-70, and TE7. |
| Biocompatibility | Evaluated and confirmed. |
| Cleaning and Disinfection | Effectiveness evaluated and confirmed. |
| Thermal, Electrical, Mechanical Safety | Evaluated and confirmed. |
| Quality Systems | Design, development, and quality process conform with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
2. Sample sized used for the test set and the data provenance:
Not applicable in this document. This submission does not describe a clinical performance study using a test set of patient data for a novel algorithm. It relies on non-clinical performance evaluations and comparisons to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts for a test set is not part of this type of 510(k) submission for a general ultrasound system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring adjudication 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 not an AI-assisted diagnostic device where such a study would be performed to evaluate improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of diagnostic accuracy for a novel algorithm. The "ground truth" for this ultrasound system would be its adherence to established engineering, safety, and performance standards as verified through non-clinical testing and comparison to predicate devices, rather than a clinical ground truth for disease diagnosis.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning submission.
9. How the ground truth for the training set was established:
Not applicable. There is no mention of a "training set" or ground truth establishment for such a set.
§ 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.