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The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediative patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System consists of the main unit named clover series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley and travelling case.

Three models for the main units are included in this submission that is Clover 50, Clover 60 and Clover 70. Seven different models of probes are available for the Clover series.

The provided text describes the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets acceptance criteria in a clinical setting with human subjects, nor does it detail a standalone algorithm performance, MRMC study, or ground truth establishment relevant to AI.

However, it does describe the performance testing criteria and results for various measurement accuracies and modes of operation. It considers these performance tests as evidence for substantial equivalence, implying they serve as acceptance criteria for the device's technical functionality relative to the predicate devices.

Here's a breakdown of the information that can be extracted, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was compared against the listed predicate device (Mindray M7/M7T, K131690). The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be "substantially equivalent" to or better. The table shows the performance of the Clover 70 model and compares it to the predicate device.

Note: The predicate device's performance appears to set the acceptance criteria for the new device. Both devices are marked 'S' (Same) indicating substantial equivalence in these performance metrics.

2. Sample size used for the test set and the data provenance

The document refers to "Performance testing was conducted on the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria." However, it does not specify the sample size used for this performance testing. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as this was non-clinical performance data, likely gathered in a lab or testing environment rather than a clinical dataset from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The ground truth for this type of performance testing would typically be based on highly accurate physical measurements using calibrated equipment rather than expert human interpretation.

4. Adjudication method for the test set

This information is not provided. Given it's non-clinical performance metrics, an adjudication method (like 2+1, 3+1) would not be applicable in the same way as for clinical studies involving human interpretation.

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

There is no mention of an MRMC comparative effectiveness study or any AI component. The device described appears to be a traditional diagnostic ultrasound system and not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no mention of a standalone algorithm or AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance testing metrics (distance, area, velocity, etc.), the ground truth would likely be established using precise physical phantoms and calibrated measurement tools, rather than clinical expert consensus, pathology, or outcomes data. The document does not explicitly state the method, but this is standard for ultrasound system calibration and performance verification.

8. The sample size for the training set

There is no mention of a training set, as this is not an AI/ML device.

9. How the ground truth for the training set was established

There is no mention of a training set or its ground truth, as this is not an AI/ML device.

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The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.

M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a 510(k) summary provided by Mindray. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria through a clinical study.

The document details:

• Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
• Regulatory Classification: Class II, Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570).
• Intended Use: General diagnostic ultrasound imaging for various applications (fetal, abdominal, intra-operative, small organ, neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology exams) across different patient populations.
• Comparison to Predicate Devices: Lists several Mindray ultrasound systems (M7, M5, DC-70, DC-8, M9) and states that the new device has "the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
• Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and conformance with various medical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1).

It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance data.
7. Details on the type of ground truth used (expert consensus, pathology, outcomes data).
8. Information on how ground truth for training data was established.

This document serves as a regulatory clearance for a traditional medical device (ultrasound system), not an AI/ML-driven device that typically requires detailed clinical performance studies and acceptance criteria as outlined in your prompt.

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The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

The provided text describes the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. However, it does not explicitly state acceptance criteria in the typical sense of quantitative thresholds for performance metrics. Instead, it outlines the scope of the device's intended use and compares its features and compliance with standards to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, explicit quantitative acceptance criteria are not presented. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, design features, safety standards compliance, and modes of operation.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Clinical testing is not required." This implies that the device's performance was not evaluated through a clinical study with a "test set" of patient data in the typical sense that would involve a sample size and data provenance (country of origin, retrospective/prospective). The assessment is based on non-clinical tests (e.g., engineering benchmarks, compliance with standards) and comparison to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as "Clinical testing is not required." Therefore, there was no "ground truth" for a test set established by experts in this context.

4. Adjudication Method:

Not applicable, as "Clinical testing is not required."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe any MRMC studies or the use of AI. The devices are diagnostic ultrasound systems, not AI-powered diagnostic aids, and the submission is for an updated version of existing devices, primarily focusing on hardware and software updates and expanded indications.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance evaluation without human-in-the-loop.

7. Type of Ground Truth Used:

Not directly applicable in the context of clinical performance evaluation (e.g., pathology, outcomes data). For the purpose of regulatory submission, the "ground truth" for demonstrating substantial equivalence is compliance with established safety and performance standards for diagnostic ultrasound equipment (e.g., acoustic output, electrical safety, biocompatibility) and functional equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device regulatory submission for an ultrasound system, not for an AI/machine learning algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this device in the context of an AI algorithm.

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