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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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Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), Thoracic Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.

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(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), 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.

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). Subject device 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 an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or reported device performance metrics for the Consona N9/N8/N7 series Diagnostic Ultrasound System. The submission is a 510(k) premarket notification for substantial equivalence, not a performance study against specific acceptance criteria.

The document primarily focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices (primarily the Mindray MX7, K212900) in terms of intended use, imaging modes, features, functions, and technological characteristics.

Instead of a table of specific performance metrics, the document highlights:

• Indications for Use: The subject device's indications are comparable to the predicate.
• Patient Contact Materials: Same as predicate or tested under ISO 10993-1.
• Acoustic Power Levels: Below FDA limits and same as the predicate (MX7).
• Electrical and Physical Safety Standards: Complies with FDA recognized standards, same as the predicate (MX7).
• Features and Functions: Same as predicate devices, with new options being either improvements or enhancements of cleared functions, with no new intended uses or clinical risks introduced.

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

The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, there is no test set, no sample size, and no data provenance (e.g., country of origin, retrospective/prospective) related to clinical performance for this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there were no clinical studies conducted and no test set, this information is not applicable. Ground truth for clinical performance was not established by experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for performance evaluation.

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

No MRMC study was done, as the document states that clinical studies were not required and were not performed. Therefore, there's no reported effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was conducted or reported, as this is a general-purpose diagnostic ultrasound system, not an AI-driven diagnostic algorithm. The new features like "Smart Calc" are described as semi-automatic tools that assist the user, implying a human-in-the-loop design, but no performance study specific to this feature is detailed.

7. Type of Ground Truth Used

Given the absence of clinical studies, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The basis for substantial equivalence relies on technical specifications, compliance with safety standards, and functional comparison to predicate devices, rather than clinical performance data against a defined ground truth.

8. Sample Size for the Training Set

Not applicable. This submission concerns a diagnostic ultrasound system and does not involve an AI model with a distinct "training set" in the conventional sense of machine learning algorithms requiring large datasets for training. The "new options" like Smart Calc are described as improvements or enhancements but not as standalone AI algorithms whose performance requires training and validation datasets.

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

Not applicable, as there was no training set for an AI model.

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Consona N6, Consona N6 Pro, Consona N6 Super, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona No Elite, Consona N6T 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,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), Thoracic/Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast imaging (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.

Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T 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. Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, Amplitude PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

Subject device 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 a diagnostic ultrasound system (Consona N6 series). It appears the device does not rely on AI features requiring specific performance metrics or a human-in-the-loop study for its predicate equivalence. The summary explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, the requested information about acceptance criteria, specific study designs (MRMC, standalone), ground truth establishment for a test set and training set, and expert qualifications for AI/ML performance evaluation cannot be extracted from this document because such studies were not deemed necessary for this device's regulatory review.

The document describes a general diagnostic ultrasound system and focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Similar applications (fetal, abdominal, cardiac, etc.)
• Technological Characteristics: Similar imaging modes (B, M, Doppler), transducers, and features.
• Non-clinical Tests: Compliance with acoustic output, biocompatibility, electrical safety, and software standards.

The only "new option" mentioned that might be interpreted as having an "intelligent" component is "Smart Calc," described as: "Semi-automatically recognizes the contour of the target area and measures the diameter, area and circumference of the target area. The user needs to identify the target area first. When the measures results are not satisfactory, the user can use the trackball to manually edit the contour." However, this is presented as an enhancement based on cleared functions, not a new intended use or a feature requiring a specific AI/ML performance study as typically understood in the context of FDA submissions for AI-enabled devices.

Summary of what cannot be provided given the document:

• Table of acceptance criteria and reported device performance for AI features: Not provided as specific AI performance studies were not cited.
• Sample size and data provenance for a test set: Not applicable; no such test set was described for AI performance.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study, effect size: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable for AI performance studies.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

Information that can be extracted related to the device as a whole (not AI-specific):

• Non-clinical Tests: The device underwent testing for acoustic output (NEMA UD 2-2004), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), biocompatibility (ISO 10993-1), and software lifecycle processes (IEC 62304). This demonstrates the device meets general safety and performance criteria through adherence to recognized standards.
• Clinical Studies: Explicitly stated as "Not applicable."
• Device Performance: The conclusion states that the device "was found to have a safety and effectiveness profile that is similar to the predicate device" based on "performance data as documented in the study" (referring to the non-clinical tests described).

In conclusion, this document does not contain the information requested about AI acceptance criteria and study designs because the device, as described for this 510(k) submission, does not appear to be an AI-enabled device requiring such specific performance evaluations for its regulatory clearance, or at least, those details are not provided in this public summary.

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The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph.(cardiac), peripheral vessel and urology exams.

The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics.

Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

The proposed Labat series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.

The Labat series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Nine models for the main units are included in this submission, that is Labat SE, Labat SP, Labat SG, Labat PE, Labat PG, Labat TE, Labat TG, Labat IE and Labat IG. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, Holo PW, Anatomic M (AMM), Tissue Doppler Imaging (TDI) and the combined modes. 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 Labat series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG cables, gel warmer, magnetic cup, foot switch, barcode reader, laser marker. TEE( transesophageal echocardiography) architecture arm, etc.

Ten different models of probes are available for the Labat series, that is C6-1B-H, C8-3-H, L15-4WB-H, L15-4NB-H, L22-10-H, L15-6-H, LH15-6-H, SP5-1-H, EV11-3-H, P7-3T-H.

The provided text describes the Labat series Diagnostic Ultrasound System (K210154). However, it does not contain information about acceptance criteria for device performance or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Mindray TE7/TE5 Diagnostic Ultrasound System, K180912) and conformity to various safety and performance standards. It explicitly states: "The subject of this premarket submission, Labat series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving specific performance metrics, as this information is not present in the provided text.

The closest information available that might relate to "acceptance criteria" and "performance" are the compliance with recognized standards for safety and acoustic output, but these are not diagnostic performance metrics.

I can, however, extract other requested information that is present in the document:

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

• Not applicable (N/A): The document does not specify acceptance criteria relating to diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Labat series Diagnostic Ultrasound System. It focuses on safety and technical compliance.

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

• N/A: No clinical test set data is described, as the device "did not require clinical studies to support substantial equivalence." The performance data shared relates to engineering and biocompatibility testing.

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):

• N/A: No clinical test set or ground truth determination by experts is mentioned, as no clinical studies were performed.

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

• N/A: No clinical test set and thus no adjudication method 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:

• No: No MRMC study was done, nor is there any mention of AI assistance in this device's description.

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

• N/A: No standalone algorithm performance study was mentioned. The device is a diagnostic ultrasound system operated by professional clinical staff.

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

• N/A: No ground truth for clinical performance is mentioned, as no clinical studies were conducted to assess diagnostic accuracy.

8. The sample size for the training set:

• N/A: The document does not describe any machine learning or AI components that would require a "training set" in the context of diagnostic accuracy. The software verification and validation are for the operational software of the device, not for a diagnostic algorithm with a training set.

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

• N/A: As there is no mention of a training set for a diagnostic algorithm, this question is not applicable.

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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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Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.

This device is a general purpose diamostic 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.

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(Real-time 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 R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.

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

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.

However, I can extract information related to the device's broader regulatory and non-clinical testing.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."

However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.

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

Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.

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

Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or ground truth was established that would require adjudication.

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/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.

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

Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.

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

Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.

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

Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.

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The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gvnecology, Obstetric. Cardiac, Small parts. Urology, Musculosketal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.

Acclarix AX3 Series/ Acclarix LX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text describes a 510(k) premarket notification for a Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove a device meets those criteria for novel technology.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not available in this document. The document primarily focuses on explaining how the new device is similar to already approved ultrasound systems and transducers.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in terms of specific performance metrics with acceptance criteria and their corresponding reported values. Instead, the document claims substantial equivalence to predicate devices based on:

• Intended Use/Indications for Use
• Mode of Operations
• Design principles
• Hardware and software platforms
• Transducer types
• Acoustic Output (stated to be below FDA limits)
• Materials of transducers and needle guide brackets

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

• Test Set Sample Size: Not provided. The document states "Clinical testing is not required" and primarily relies on non-clinical tests and comparison to predicate devices.
• Data Provenance: The document implies that the "clinical applications" and "imaging modes" added to the new device are based on what was already cleared for the Acclarix LX9 series (K192879) and other predicate devices (K200232 and K201693). This suggests a reliance on retrospective data and established performance of predicate devices, rather than new prospective clinical trials for this specific submission. The origin of the data for the predicate devices is not specified in this document.

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

• Not applicable. Since clinical testing was not required for this submission, there was no separate test set requiring new ground truth establishment by experts for specific AI algorithm performance.

4. Adjudication method for the test set:

• Not applicable. No specific adjudication method is mentioned as there was no dedicated clinical test set described for new performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No, an MRMC study was NOT done. The document explicitly states "Clinical testing is not required" and focuses on substantial equivalence based on technical specifications and previously cleared indications. There is no mention of human readers or AI assistance.

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

• Not applicable. This document is for a diagnostic ultrasound system, not an AI algorithm. While the system may employ internal processing (which could include algorithmic components), the submission does not detail testing of standalone AI performance against a ground truth.

7. The type of ground truth used:

• Not applicable for novel performance claims. The "ground truth" implicitly relies on the established and cleared performance of the predicate diagnostic ultrasound systems and their associated transducers. The "Acoustic output testing" was done "as per the guideline 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated June 27, 2019," which suggests adherence to industry standards and regulatory guidance for ultrasound device performance, rather than clinical ground truth for a specific medical condition.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or training of a new AI algorithm. It refers to a diagnostic ultrasound system and its transducers.

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

• Not applicable. As no new AI algorithm development is described, there is no training set or ground truth specific to an algorithm's training.

Summary of what the document does provide:

The document serves as a 510(k) submission arguing for the substantial equivalence of the new Edan Instruments Diagnostic Ultrasound Systems (Acclarix AX3 series and Acclarix LX3 series) to existing cleared predicate devices. The arguments are based on:

• Non-clinical performance tests demonstrating compliance with relevant electrical safety, EMC, and acoustic output standards (ANSVAAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10).
• Comparison of intended use, indications for use, mode of operations, design principles, hardware/software platforms, and transducer types to previously cleared Edan Instruments ultrasound systems (K192791, K192879) and other predicate devices (K200232, K201693).
• The argument is that the differences are minor and do not raise new questions of safety or effectiveness. For example, new clinical applications, transducers, and imaging/measurement modes have already been cleared on other predicate devices.

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