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The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80 Exp, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, 175-Endo, 170-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training 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 system is applicable for people who need clinical ultrasound examination.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape S90 Exp Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

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

This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Strain Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.

The provided text describes the Sonoscape Medical Corp.'s S90 Exp Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria related to a performance study for the device's clinical or algorithmic performance, nor does it detail a study that proves the device meets such criteria.

The document primarily focuses on:

• Indications for Use: What the device is intended for (various clinical applications and modes of operation).
• Comparison to Predicate Devices: Explaining how the S90 Exp Series is similar to previously cleared devices in terms of intended use, regulations, safety standards, acoustic output, probes, biopsy brackets, and technical characteristics.
• Non-Clinical Tests: Listing compliance with electrical safety, EMC, acoustic, and software verification standards.

Therefore, I cannot provide the requested information. The text explicitly states:

"No clinical testing was required."

This indicates that, for the purpose of this 510(k) submission, a clinical study demonstrating the device's performance against specific clinical acceptance criteria was not performed or submitted. The substantial equivalence argument is based on the device's similarity to predicate devices and compliance with non-clinical technical standards.

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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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TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), ThoracicPleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite 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, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X TEX10 Lite 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.

This document does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The provided text is a 510(k) summary for a Mindray diagnostic ultrasound system, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria.

The document states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information.

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MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 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 cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , transesoph(Cardiac) 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, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, i iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver) mode.

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 text is a 510(k) summary for a diagnostic ultrasound system (MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System). This document is primarily focused on demonstrating substantial equivalence to a predicate device based on technical characteristics, intended use, and non-clinical testing.

Based on the provided document, the device did not undergo clinical studies to prove its performance against acceptance criteria in the manner requested (i.e., a study comparing device performance against a defined ground truth, potentially involving human readers, and meeting specific statistical thresholds).

The document explicitly states:

"8. Clinical Studies
Not applicable. The subject of this submission, MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document. The submission relies on non-clinical tests to demonstrate substantial equivalence to established predicate devices.

The acceptance criteria for this type of submission are primarily met through:

• Comparison of Intended Use: Showing that the new device's intended uses are comparable to (or covered by) legally marketed predicate devices.
• Comparison of Technological Characteristics: Demonstrating that the fundamental technology (e.g., imaging modes, physical principles) is substantially equivalent to predicate devices.
• Non-Clinical Performance Testing: Proving the device meets recognized safety and performance standards (e.g., acoustic output, electrical safety, electromagnetic compatibility, biocompatibility, software lifecycle, risk management).

In summary, the document does not contain the information required to populate the requested table or answer the specific questions about clinical study performance, as no such clinical study was required or performed for this 510(k) submission.

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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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