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Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided document is a 510(k) premarket notification summary for a diagnostic ultrasound system. It outlines the device description, indications for use, comparison to predicate devices, and the non-clinical tests performed. Crucially, the document states "Not applicable" for clinical studies and explicitly says, "The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, based on the provided text, there is no information available regarding acceptance criteria and a study that proves the device meets those criteria in the context of an "AI" or "software" performance evaluation as typically seen for AI/ML-enabled devices. The new features mentioned (e.g., Super Resolution CEUS, Smart Scene) are presented as improvements or enhancements based on cleared functions, or new options that passed related tests without introducing new clinical risks. The focus of this 510(k) is on demonstrating substantial equivalence to predicate ultrasound devices through non-clinical testing and shared technological characteristics.

Here's why the requested information cannot be provided from this document:

• No AI/ML Performance Claim: The document does not describe the device as an AI/ML-enabled diagnostic tool in the sense of providing automated analysis, detection, or diagnosis that would require specific performance metrics like sensitivity, specificity, or AUC based on ground truth. The "Smart Calc" feature mentioned is simply an analysis package.
• Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new ultrasound system is substantially equivalent to existing, legally marketed predicate devices primarily through engineering, safety, and functionality comparisons.
• No Clinical Study Performed/Required: The document explicitly states that clinical studies were "Not applicable" and "not required to support substantial equivalence." This means there was no de novo performance study with a test set, ground truth, or expert readers to evaluate specific diagnostic accuracy or AI assistance.

Table of Acceptance Criteria and Reported Device Performance (as inferable from the document's scope):

Regarding the specific questions about an AI/ML performance study, the answers are "N/A" (Not Applicable) because such a study was not performed or required for this 510(k) clearance:

1. A table of acceptance criteria and the reported device performance: See table above for inferable, non-AI criteria.
2. Sample sized used for the test set and the data provenance: N/A (no clinical test set for AI performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: No MRMC study for AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was performed.
7. The type of ground truth used: N/A.
8. The sample size for the training set: N/A (no mention of a training set for an AI model).
9. How the ground truth for the training set was established: N/A.

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Resona I9, Resona I9 Exp. Resona I9T. Resona I9 Easi, Resona I9 Nasa, Resona IV. Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19, Anesus 19, Resona 19W, Recho 19, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19, Resona I9W, Recho 19, Recho 19 Pro, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B. M. PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B. Power+PW+B). Tissue Harmonic Imaging, Smart3D, 4D(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona 19, Resona 19 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

I'm sorry, but this document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It outlines the device's indications for use, its substantial equivalence to predicate devices based on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and applicable safety standards it conforms to.

However, it explicitly states under "8. Clinical Studies": "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, there is no information in this document regarding:

• Acceptance criteria tables with reported device performance for an AI/algorithm-related study.
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC studies or effect sizes of AI assistance on human readers.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory clearance for a general purpose diagnostic ultrasound system, not a document detailing the performance and validation of an AI/ML component within such a system.

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Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.

Description of Acceptance Criteria and the Study that Proves the Device Meets Them

The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.

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

• Not Applicable. As no clinical "test set" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No clinical test set requiring expert adjudication was conducted.

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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.

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

• Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.

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

• Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.

8. The sample size for the training set:

• Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.

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

• Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.

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ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, thoracc, and vacular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac and Peripheral vessel exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

ViewMate™ Multi Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M.

ViewMate™ Multi Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

This document is a 510(k) summary for the ViewMate™ Multi Ultrasound System and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert qualifications, and ground truth are not present in this regulatory document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than presenting specific performance metrics against defined acceptance criteria for a new device's core functionality.

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

This information is not provided in the document. The document states "Non-clinical Tests" were performed, but does not detail a "test set" for performance evaluation in the context of clinical or diagnostic accuracy. It refers to testing against safety and performance standards.

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 in the document. As clinical studies were deemed "Not applicable," there's no mention of experts establishing ground truth for a test set.

4. Adjudication method for the test set

This information is not provided in the document.

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

This information is not provided and is not applicable. The ViewMate™ Multi Ultrasound System is described as a "general purpose diagnostic ultrasound system" and there is no indication it incorporates Artificial Intelligence (AI) or machine learning features that would necessitate an MRMC comparative effectiveness study to assess human reader improvement with AI assistance. Clinical studies are explicitly stated as "Not applicable."

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

This information is not provided and is not applicable. Based on the device description, it's a diagnostic ultrasound system intended for use by healthcare professionals, implying human-in-the-loop operation. There is no mention of a standalone algorithm for independent performance.

7. The type of ground truth used

This information is not provided and is not applicable as clinical studies were not performed. The testing mentioned (acoustic output, biocompatibility, safety standards) does not rely on a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).

8. The sample size for the training set

This information is not provided and is not applicable. Since clinical studies were not required, and there's no mention of AI/machine learning components that typically require training sets, this detail is absent.

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

This information is not provided and is not applicable for the same reasons as point 8.

Summary of what the document does provide regarding device evaluation:

The document indicates that the ViewMate™ Multi Ultrasound System underwent non-clinical tests to demonstrate its safety and effectiveness. These tests included:

• Acoustic output evaluation (against NEMA UD 2-2004 (R2009))
• Biocompatibility evaluation (against ISO 10993-1 Fifth edition 2018-08)
• Cleaning and disinfection effectiveness
• Thermal, electrical, and mechanical safety (against AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text), IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-2-37 Edition 2.1 2015)
• Software life cycle processes (against IEC 62304 Edition 1.1 2015-06)
• Usability engineering (against IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1 Edition 1.0 2015-02)
• Risk management (against ISO 14971 Third Edition 2019-12)

The "study" or evaluation performed was primarily a comparison against recognized industry standards and a predicate device (Resona I9 K210699) to establish substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy or efficacy endpoints. The acceptance criteria for these non-clinical tests would be compliance with the requirements of the listed standards. For example, for acoustic output, the acceptance criterion would be that the acoustic power levels are "below the limits of FDA."

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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Reape View, TDI, Color M. Strain Elastography, Contrast imaging (Contrast imaging (Contrast agent for LVO), STE,STQ.

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array. convex array, pencil phased and phased array.

The provided text is a 510(k) Summary for a Diagnostic Ultrasound System, which is a general-purpose diagnostic imaging device. For such devices, the FDA typically relies on non-clinical performance data (e.g., electrical safety, acoustic output, electromagnetic compatibility, software validation) to demonstrate substantial equivalence to a predicate device, rather than clinical studies with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity.

Therefore, the document explicitly states: "8. Clinical Tests: Not Applicable."

This means that the type of study for proving the device meets acceptance criteria, in the context of diagnostic performance metrics, was not performed for this submission. The "acceptance criteria" discussed in the document are primarily related to safety, electrical performance, and adherence to recognized standards, rather than clinical diagnostic efficacy.

Given the information in the provided document, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical tests were "Not Applicable" and no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device's efficacy, a table of diagnostic acceptance criteria and performance cannot be generated from the provided text.

However, the document lists compliance with various regulatory and safety standards, which can be seen as the "acceptance criteria" the device met for its substantial equivalence determination. The "reported device performance" is its demonstration of compliance with these standards and its similarity to the predicate device.

• IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
• IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
• IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes.
• ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
• NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
• AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
• IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
• IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety.
• The device was found to conform with applicable medical safety standards (listed above).
• The acoustic power levels are below FDA limits, similar to the predicate device.
• The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device.
• The device's safety and effectiveness profile is found to be similar to the predicate device. |

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

• Sample Size for Test Set: Not applicable for diagnostic performance as no clinical tests were performed.
• Data Provenance: Not applicable for diagnostic performance. For safety and performance evaluations, the data would typically come from internal engineering and lab testing conducted by the manufacturer (Shenzhen Mindray Bio-Medical Electronics Co., LTD in China).

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

• Not applicable as no clinical tests or diagnostic performance evaluations requiring expert ground truth were conducted or reported in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable as no clinical tests or diagnostic performance evaluations requiring adjudication were conducted or reported in this 510(k) summary.

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

• No MRMC comparative effectiveness study was done or reported. This device is a general diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study for 510(k) clearance.

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

• Not applicable. This is a diagnostic ultrasound system, not an standalone algorithm. The device has "Smart" features (e.g., Smart 3D, Smart Planes FH, Smart Pelvic, iClear+), but these are integrated functionalities of the ultrasound system itself, not standalone algorithms requiring separate "algorithm-only" performance evaluation in the context of this 510(k). The regulatory pathway for this device does not necessitate such a study as it's a general-purpose ultrasound.

7. The type of ground truth used

• Not applicable for diagnostic performance metrics, as no clinical efficacy studies were conducted. For the non-clinical tests, the "ground truth" would be the established specifications and limits defined by the international and national standards to which the device was tested for compliance.

8. The sample size for the training set

• Not applicable. This document describes a traditional diagnostic ultrasound system. While it has "Smart" features that likely involve internal algorithms some of which might be trained, the document does not provide details on algorithm training, or a "training set" in the context of a machine learning model submitted for software as a medical device (SaMD) clearance.

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

• Not applicable, as a training set for a machine learning model is not discussed or required for this type of 510(k) submission for a general diagnostic ultrasound system.

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Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 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, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp. Nuewa I9 Easi. Anesus I9, Anesus I9 Easi. Eagus I9 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).

The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text is a 510(k) summary for the Resona I9 series Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of features. It explicitly states that clinical studies were not required or performed for this submission.

Therefore, many of the requested elements regarding acceptance criteria and a study proving the device meets these criteria (especially those related to AI performance, human reader improvement, and ground truth establishment) cannot be found in this document. The device described is a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic tool, which further explains the absence of such information.

However, I can extract the general acceptance criteria for this type of device based on the non-clinical tests performed to demonstrate safety and effectiveness.

Here's a breakdown of the information available and the parts that are explicitly stated as "Not Applicable" or absent:

Acceptance Criteria and Device Performance

Since this is a 510(k) for a diagnostic ultrasound system and not an AI-driven device with specific performance metrics like sensitivity/specificity, the acceptance criteria are related to safety, electrical performance, acoustic output, and compatibility. The "reported device performance" is the manufacturer's claim that the device passed these tests and conforms to the standards.

While there isn't a table of specific numerical performance criteria (e.g., minimum diagnostic accuracy), the general acceptance is based on conformity to recognized medical device standards and comparability to predicate devices.

Study Details (Based on the Provided Document)

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided. The document states "Non-clinical Tests" were performed, but does not provide details on specific sample sizes for these tests (e.g., how many transducers were tested for acoustic output, or how many materials for biocompatibility). The document describes the system and its features, not a clinical trial or performance study based on patient data.
   • Data Provenance: Not specified, as it's not a clinical data study. Non-clinical tests are typically performed in a lab setting by the manufacturer.

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

   • Not Applicable. As this is a 510(k) based on non-clinical testing and comparison to a predicate device, there is no mention of expert-established ground truth for a test set in the context of diagnostic accuracy.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No clinical test set with human assessment and adjudication is mentioned.

4. 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:

   • No. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies for AI performance improvement.

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

   • Not Applicable. This is a diagnostic ultrasound imaging system, not a standalone AI algorithm. While it mentions "new software and hardware options" and features like "Smart Scene 3D" or "High frame rate STE," these are described as "improvements or enhancement based on the cleared functions to facilitate users," implying integrated features within the ultrasound system, not a separate AI algorithm requiring standalone performance validation against a ground truth. None of these features are presented as standalone diagnostic algorithms.

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

   • Not Applicable. For the non-clinical tests, "ground truth" would be the established scientific/engineering standard for a given test (e.g., a calibrated device for acoustic output measurements, or a specified biochemical reaction for biocompatibility). There is no clinical ground truth (like pathology or outcomes data) mentioned, as no clinical studies were performed.

7. The sample size for the training set:

   • Not Applicable. The document does not discuss a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set is mentioned in the context of machine learning.

In summary, the provided 510(k) document is for a general diagnostic ultrasound system and asserts substantial equivalence via non-clinical testing and comparison to predicate devices, not through clinical performance studies involving a test set, expert readers, or AI algorithm validation against ground truth.

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M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, 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 and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, CW-Mode, CW-Mode, Color-Mode , Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

The provided document is a 510(k) Summary for a diagnostic ultrasound system. It outlines the device's features, intended use, and comparison to predicate devices, but it explicitly states that no clinical studies were performed.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance based on clinical studies.
• Sample size, data provenance, ground truth establishment, or expert details for a test set.
• Adjudication method or MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details (sample size, ground truth establishment).

The document explicitly states:

8. Clinical Studies

Not applicable. The subject of this submission, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

This indicates that the substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, and compliance with recognized standards) and a comparison of technical characteristics and intended uses with legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria for AI-assisted performance or human-in-the-loop improvements.

The "acceptance criteria" for this device, as implied by the document, are primarily related to safety and effectiveness being substantially equivalent to predicate devices through engineering and design validation, and adherence to relevant industry standards. There are no performance metrics provided that would typically be seen for an AI/ML-driven device requiring clinical validation against specific performance targets.

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TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging (Contrast agent for LVO),TDI,Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View.

TE7/TE5/TE7 Max/ TE5 Max/TE9 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode , Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO),TDI, Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View. This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array and Volume probe.

This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD. TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System. It largely focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailed performance studies against specific acceptance criteria for novel AI features.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement for ground truth is not explicitly provided in this type of regulatory submission. The submission primarily relies on showing that the new features or modifications are "similar to" or "have been cleared with" existing features in predicate devices. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance metrics for the added features like Smart IVC, Smart VTI, Smart B-Line, EPSS, Smart Trace, Auto GA, Smart Bladder, or Smart FHR OB1. Instead, it states that these features are "similar to" or "have been cleared on" predicate devices, implying that their performance is considered equivalent and therefore acceptable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on "similarity" to predicate devices, implying that testing data from those predicate devices supports the current submission, or that specific testing for these features was performed internally without detailing the datasets.

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)

This information is not provided. The document makes no mention of expert involvement for ground truth establishment related to the new features. Given the approach of "similarity to cleared features," it's likely that established methods of performance evaluation for ultrasound systems were followed, but the specifics are not disclosed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission does not claim to include AI assistance to human readers that would necessitate such a study; rather, it describes automated measurement and image processing features that are presumably integrated into the device's functionality.

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

While the new features (e.g., Smart IVC, Smart VTI, Smart B-Line, Smart Bladder, Smart FHR OB1) imply automated algorithms perform measurements or detections, the document does not explicitly describe a standalone algorithm-only performance study. The context is the overall ultrasound system, and these features are presented as integrated capabilities of the device.

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

This information is not explicitly stated. Given the nature of ultrasound imaging and a 510(k) submission primarily focused on substantial equivalence for a diagnostic ultrasound system:

• For quantitative measurements (e.g., Smart IVC, Smart VTI, Auto GA, Smart Bladder, Smart FHR OB1), the ground truth would likely be established through manual measurements by trained Sonographers/Physicians using validated techniques, or comparison against other gold standard measurement methods if available.
• For image processing and detection features (e.g., Smart 3D, iScape View, Smart B-Line, Smart Trace), the ground truth would likely involve expert visual assessment and consensus by radiologists/cardiologists/specialists interpreting the images and verifying the function's output.
  However, this is inferred, not stated.

8. The sample size for the training set

This information is not provided. The document is a 510(k) summary for an ultrasound system, not a detailed technical report for an AI algorithm. In submissions of this type for devices primarily relying on substantial equivalence, detailed training set information is often not required or included unless the AI component is a truly novel aspect requiring extensive de novo review. The features described are framed as similar to those already cleared.

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

This information is not provided.

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