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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), 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.

Here's an analysis of the provided text regarding acceptance criteria and study information for the M7/M7T Diagnostic Ultrasound System:

Summary of Device Performance Study Information

The provided 510(k) summary for the M7/M7T Diagnostic Ultrasound System is for a general-purpose ultrasound device. As such, it primarily focuses on establishing substantial equivalence to predicate devices and adherence to safety and performance standards rather than presenting a clinical study with specific acceptance criteria related to diagnostic accuracy.

The document indicates that the device has been evaluated for:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, and mechanical safety

It states that the device conforms to applicable medical safety standards, including UD 2, UD 3, IEC 60601-1 series, UL 60601-1, ISO14971, ISO 10993-1, IEC62304, and IEC60601-2-18.

Acceptance Criteria and Reported Device Performance

Since this is a filing for a general-purpose ultrasound system based on substantial equivalence, there are no specific diagnostic accuracy acceptance criteria or performance metrics (like sensitivity, specificity, AUC) reported in this summary. The "performance" being demonstrated here is primarily the device's adherence to relevant safety and performance standards, and its technological characteristics being comparable to predicate devices.

Specific Study Information Not Provided in this Document:

Based on the provided text, the following information is not available:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No clinical test set or data from a diagnostic performance study is mentioned. The evaluation is focused on engineering and safety standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth study is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set is described.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This document describes a general diagnostic ultrasound system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical ground truth study is described.
7. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.

Conclusion from the Document:

The conclusion states that the "Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the M7/M7T Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

This heavily implies that due to the nature of the device (a general-purpose ultrasound system) and the regulatory pathway chosen (510(k) substantial equivalence), the "study" demonstrating its meeting of acceptance criteria consists of:

• Verification and validation against engineering and safety standards (as listed above).
• Bench testing and performance verification to ensure the device functions as intended (e.g., imaging modes, frequency ranges).
• Comparison of its intended uses and technological characteristics to already cleared predicate devices.

There is no mention of a clinical trial or a study assessing the diagnostic accuracy or efficacy of the M7/M7T Diagnostic Ultrasound System in this summary. Such studies are typically not required for general-purpose ultrasound systems cleared via the 510(k) pathway when substantial equivalence to existing devices is established based on technical and functional similarities and adherence to recognized standards.

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