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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, 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.

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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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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) 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 [K103677](https://510k.innolitics.com/search/K103677) is a 510(k) Pre-Market Notification for the M7/M7T Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing predicate devices and ensuring the device meets various safety and electrical standards. It does not contain the specific types of performance studies or acceptance criteria that would typically be associated with AI/CADe devices.

In the context of the provided document, the "acceptance criteria" primarily refer to compliance with recognized medical device safety standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. Therefore, the information requested in the prompt, which is geared towards AI/CADe device evaluation, is largely absent from this 510(k) summary.

Here's a breakdown of why many sections of your request cannot be fulfilled based on the provided text:

• No AI/CADe Device: The M7/M7T Diagnostic Ultrasound System is described as a general-purpose diagnostic ultrasound system. There is no mention of any AI or CADe (Computer-Aided Detection/Diagnosis) functionality within the device. Thus, there is no AI algorithm to evaluate.

Given this, I cannot provide the requested information that pertains to AI/CADe device performance or clinical studies. The document only describes the device's technical characteristics, intended use, and conformance to general safety and electrical standards.

If you have a different document that describes an AI/CADe device, I would be happy to analyze it according to your criteria.

Ask a specific question about this device

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.

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.

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