(42 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, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) 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 predicate devices and does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria.
Therefore, many of the requested details related to acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in the provided text.
Based on the available text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, it makes a general statement about safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: "as safe and effective as the legally marketed predicate devices") | "The conclusions drawn from testing of the M7/M7T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." |
| Conformance to medical device safety standards | "The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "drawing from testing" generally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
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:
- MRMC study: No indication of a MRMC study. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: Not applicable. This device is a diagnostic ultrasound system, which requires a human operator for image acquisition and interpretation, not a standalone algorithm.
7. The type of ground truth used:
- Type of ground truth: Not specified. Given it's an ultrasound system, the "testing" likely refers to technical performance validation, image quality assessment, and safety testing rather than diagnostic ground truth in a clinical trial context as implied by "ground truth" for an AI device.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/ML-based device that would typically have a "training set."
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable. As above, this document describes a traditional diagnostic ultrasound system.
§ 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.