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510(k) Data Aggregation
(53 days)
Supersonic Imagine
The SuperSonic Imagine® SuperSonic® Hepa Vi™ ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric.
Modes of operation include: B-mode ID : Panoramic Imaging; Spatial Compounding], M-mode. Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); Shear Wave dispersion Viscosity (Vi PLUS); Combination Modes [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/ SWE); (B/M-mode/Color flow)].
In addition, the SuperSonic® HepaVu™ ultrasound diagnostic systems and associated transducers are intended for:
- · Measurements of abdominal anatomical structures,
- · Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- · Measurements of brightness ratio between liver and kidney,
- · Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion
The shear wave speed, ultrasound attenuation coefficient, backscattering coefficient, viscosity and stiffness measurements, the brightness ratio, the visualization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.
1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.
The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic hepatology purpose ultrasound imaging studies.
The system contains a scan converter and can be coupled to a variety of linear and curved trransducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.
The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
The principle software change with respect to the MACH software version is related to the following feature:
- -Backscattering coefficient (BSc): The backscattering coefficient characterizes the ability of a tissue to reflect incoming ultrasound wave back to the direction from which they came. Local measurement of the backscattering is expressed in db/cm.str over a range of values (from -38 db/cm.str to -24 db/cm.str).
Bsc PLUS mode is available for all Abdominal presets on C6-1X and C9-2X transducers.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the SuperSonic® HepaVu™ ultrasound diagnostic system, outlining its indications for use, technological characteristics compared to a predicate device, and non-clinical testing for substantial equivalence. It explicitly states that "No clinical tests have been performed on SuperSonic® HepaVu™ System." Therefore, the requested information cannot be extracted from this document.
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(98 days)
SuperSonic Imagine
The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].
In addition, the Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:
-Measurements of abdominal anatomical structures,
- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- Measurements of brightness ratio between liver and kidney,
- Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- Measurements of breast anatomical structures
- Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- · Visualization of breast morphology using shearwave elastography and micro-vascularization 2D mapping.
The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.
This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.
The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.
The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
The provided text is a 510(k) Summary for an ultrasound diagnostic system. It explicitly states in section 8, "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable.".
Therefore, the document does not contain information regarding:
- Acceptance criteria and reported device performance (beyond compliance with technical standards).
- Details of a study proving the device meets acceptance criteria.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only discusses non-clinical tests (electrical safety, EMC, acoustic output, biocompatibility) which confirmed the device performs according to its intended use and complies with relevant standards. It concludes that the device is "at least as safe and effective as the predicate devices".
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(197 days)
SuperSonic Imagine
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
-Measurements of abdominal anatomical structures,
- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- Measurements of brightness ratio between liver and kidney,
- Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Furthermore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- Measurements of breast anatomical structures
- · Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping
The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor.
An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and submodes as CFI-ColorFlow Imaging,
CPI-ColorPower Imaging-also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
Device: SuperSonic Imagine AIXPLORER® MACH30/SUPERSONIC MACH30, AIXPLORER® MACH20/SUPERSONIC MACH20, SUPERSONIC MACH40 Ultrasound Diagnostic Systems.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (AIXPLORER® MACH range sw V2, K191007) and adherence to recognized standards.
However, based on the intended use for liver disease and breast masses, and the discussion of ShearWave™ Elastography (SWE), we can infer the acceptance criteria and reported performance qualitatively:
| Acceptance Criteria (Inferred from Intended Use & Discussion) | Reported Device Performance (Qualitative, from Summary) |
|---|---|
| For Liver Disease: | |
| - Aid in clinical management of adult and pediatric patients with liver disease through measurements of broad band shear wave speed, tissue stiffness, brightness ratio, visualization and quantification of vascularization, microvascularization, and perfusion. | Shearwave speed, beam attenuation, viscosity, and stiffness measurements, brightness ratio, visualization, microvascularization, and quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. |
| For Breast Masses: | |
| - Aid in management of women patients with breast masses, by providing added information through shearwave elastography in conjunction with 2D gray scale imaging and vascularization to better characterize breast masses and improve diagnostic accuracy. | Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment. It can significantly improve the positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions... while preserving sensitivity. |
| - High intra-operator repeatability and inter-observer reproducibility for SWE evaluation of breast lesions to increase inter-observer agreement on global cancer risk assessment. | SWE evaluation of breast lesions increases the inter-observer agreement on their global cancer risk assessment with ultrasound, thanks to its "almost perfect" intra-operator repeatability and high inter-observer reproducibility. |
| - Contribution to defining more appropriate management strategies (e.g., accurate cancer size measurements, correlation with aggressiveness and response to neo-adjuvant chemotherapy) for breast cancers with SWE. | Evaluation of breast cancers with SWE seem to contribute to defining more appropriate management strategies through more accurate cancer size measurements, correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment. |
| General Performance: | |
| - Performance according to stated intended use and within pre-determined product specifications and external standard requirements. | "The above testing confirmed that the AIXPLORER® MACH / SUPERSONIC MACH Systems perform according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements." |
| - Substantial equivalence to predicate devices for safety and effectiveness. | "Results of non-clinical testing confirmed the substantial equivalence of the AIXPLORER® MACH / SUPERSONIC MACH Systems to the predicate device(s)." "Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The submission refers to a "clinical evaluation by literature route" and provides a "Summary of literature review." This implies that the performance claims are based on published studies, not a new clinical trial conducted specifically for this 510(k) submission.
- Data Provenance: Retrospective, as it relies on a "literature review." The specific countries of origin for the studies included in the literature review are not mentioned in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this submission. Since the clinical evidence is based on a literature review, the experts establishing ground truth would be those involved in the original studies cited, but these details are not provided in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as a new test set requiring adjudication was not explicitly created for this submission. The clinical evidence relies on previously published research.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance
- MRMC Study: The document explicitly mentions that "Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment" and "increases the inter-observer agreement." This strongly suggests that a form of comparative effectiveness study was done in the literature reviewed, comparing human interpretation with and without SWE. However, it is not explicitly stated as a new MRMC study conducted for this specific 510(k) submission.
- Effect Size: The document uses qualitative terms like "increased specificity" and "significantly improve the positive predictive value," and "almost perfect" intra-operator repeatability and "high inter-observer reproducibility" for SWE. However, no specific numerical effect sizes (e.g., AUC improvement, percentage increase in sensitivity/specificity, or agreement metrics) are provided in this summary.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an ultrasound diagnostic system that includes ShearWave™ Elastography functionality. The "clinical evaluation by literature route" focuses on the utility of SWE as an aid to human interpretation. Phrases like "Addition of Shear Wave elastography to conventional B-mode Ultrasound" and "shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses" indicate that the performance described is a human-in-the-loop scenario, where SWE provides information to aid the clinician. Therefore, a standalone (algorithm only) performance study as typically understood for an AI diagnostic device is not described here. The SWE technology itself generates quantitative data (shear wave speed, stiffness) that is interpreted by the user.
7. The Type of Ground Truth Used
Based on the literature review summary for breast masses, the ground truth likely involved:
- Pathology: "Improve the diagnostic accuracy of ultrasound" and "assess the risk of lesion malignancy" strongly imply pathological diagnosis (biopsy results) as the ground truth for breast mass characterization.
- Outcomes Data: "More appropriate management strategies," "accurate cancer size measurements," "correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment" suggest that long-term patient outcomes or confirmed clinical diagnoses were used as ground truth in the cited literature.
For liver disease, although not explicitly stated, ground truth would similarly rely on established diagnostic methods for liver pathology and progression.
8. The Sample Size for the Training Set
Not applicable. This submission is for an ultrasound system with enhanced features (including ShearWave™ Elastography), not a standalone AI model that undergoes a distinct training phase in the typical sense of deep learning or machine learning. The underlying SWE algorithms would have been developed and validated through extensive research, but a "training set" as understood for a new AI algorithm is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. The document does not describe a new AI model with a dedicated training set. The clinical evaluation relies on previously established literature for the performance of SWE technology.
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(124 days)
Supersonic Imagine
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
Measurements of abdominal anatomical structures,
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen Measurements of brightness ratio between liver and kidney,
Visualization of abdominal vascularization, microvascularization and perfusion,
Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart-based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), Mmode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.
This document describes the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and their accessories. The devices are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, and Doppler fluid flow analysis of the human body. The submission is for a 510(k) premarket notification, seeking substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device and its transducers are based on demonstrating substantial equivalence to the predicate device (AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems, K191007). The reported device performance is that the new device is identical or has additions/improvements while maintaining the safety and effectiveness of the predicate.
| Feature/Criterion | Predicate Device (K191007) | New Device (K202455) | Performance |
|---|---|---|---|
| Classification Name | Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570) | Identical | The new devices have identical classification names, indicating they fall under the same regulatory categories. |
| Class | Class II | Identical | The new devices maintain the same Class II classification. |
| Intended Use | Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body | Identical | The intended use statement for diagnostic imaging, elasticity imaging, and fluid flow analysis is identical, confirming the new devices perform the same core functions. |
| General Description | General purpose, mobile, software controlled diagnostic ultrasound system. Acquires and displays ultrasound data in various modes. Consists of system console and transducer. | Identical | The general description of the system's physical characteristics and core functionality is identical. |
| Clinical Applications | Abdominal, Small organs, Musculoskeletal, Fetal, GYN, Cardiac (non-invasive), Adult and neonatal cephalic, Pediatric, Urology, Vascular, Peripheral vascular, Trans-rectal, Trans-vaginal. | Identical (with new indications for specific transducers - see details below) | The core clinical applications are identical. However, some transducers exhibit "new indications" (marked with 'N' in the tables for transducers L10-2, L18-5, C9-2X, C6-1X, E12-3, MC12-3, LV16-5, LH20-6, P5-1X), broadening the scope for specific modalities on those transducers. |
| Imaging Modes (Conventional) | B-Mode (Harmonic, Fundamental), M-Mode, PW, CW, Color Doppler, Amplitude Doppler, Microvascular (Angio PL.U.S) | Identical | All conventional imaging modes are identical. |
| Other Imaging Features | Spatial compounding, Panoramic, Contrast | Identical (Addition of Contrast availability on clinical applications) | The general features are identical, with the new device explicitly stating the addition of Contrast availability on clinical applications. |
| Combination of Modes | Available | Identical | The ability to combine modes is identical. |
| Elastography | ShearWave Elastography, Strain Elastography | Identical | Both ShearWave and Strain Elastography functions are identical. |
| Design (Cart, Controls) | Mobile cart based product with control panel and monitor; Typical ultrasound imaging controls (gain, depth mode select...). | Identical | The physical design regarding the cart and user controls is identical. |
| Biopsy Guide | Available | Identical | Biopsy guidance functionality is identical. |
| Acoustic Output | Yes, as per NEMA UD-3 | Identical | The acoustic output remains within FDA guidelines as per NEMA UD-3. |
| Patient Contact Materials | Yes, per ISO 10993-1 | Identical | Patient contact materials comply with ISO 10993-1. |
| Image Review, Measurement, Calculation, Report | Yes | Identical | Features for image review, measurement, calculation, and reporting are identical. |
| General Safety | Conforms to IEC60601-1, 60601-1-2, 60601-2-37 | Identical | Compliance with general safety standards is identical. |
| Labeling | Conforms to 21 CFR Part 801 | Identical | Labeling complies with 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary for an ultrasound diagnostic system. It explicitly states in section 8: "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable." This indicates that no clinical tests were performed or relied upon for this submission. Therefore, there is no test set sample size and no data provenance in terms of patient data from clinical studies for this specific submission to evaluate the AI's performance.
The submission focuses on non-clinical testing and comparison to a predicate device. The "new indications" for transducers are for established ultrasound modalities (e.g., CEUS, Strain Elastography, new quantification methods), not a novel AI-driven diagnostic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical studies with patient data were conducted or relied upon for this 510(k) submission, there were no experts used to establish ground truth for a test set. The evaluation was based on non-clinical engineering and performance testing to demonstrate substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Not applicable" for clinical tests (Section 8). This type of study would involve human readers and their performance with and without AI assistance, which is outside the scope of this non-clinical submission for substantial equivalence based on technical specifications and functional equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe any specific "standalone" AI algorithm performance studies. While the devices include features like "ShearWave™ Elastography" and "Strain Elastography" which rely on sophisticated algorithms for tissue property assessment, these features were previously cleared on the predicate device (K191007) and are stated to be "Identical." The submission emphasizes functional equivalence and safety rather than novel AI performance claim. The new features for the AIXPLORER® MACH / SUPERSONIC MACH systems are "Vi PLUS" and "Att PLUS & SSp PLUS" for specific transducers (L10-2, C6-1X, C9-2X). These are described as measurements related to vascularization, microvascularization, perfusion, and attenuation/shear wave speed, which may involve advanced processing, but their standalone performance is not detailed in the context of a dedicated performance study against ground truth.
7. The Type of Ground Truth Used
Given the absence of clinical studies, there was no ground truth derived from expert consensus, pathology, or outcomes data in the context of this 510(k) submission. The "ground truth" for the non-clinical testing was defined by established engineering and performance standards (e.g., acoustic output measurements against NEMA standards, electrical safety against IEC standards) and comparison to the predicate device's established performance.
8. The Sample Size for the Training Set
Since no AI-specific clinical performance study for a novel algorithm was described, there is no information provided regarding a training set sample size. The submission is focused on demonstrating that the new device's technical specifications and functionality are substantially equivalent to a previously cleared predicate device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for a novel AI algorithm's clinical performance, this information is not applicable and not provided in the document.
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(192 days)
Supersonic Imagine
The SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-CYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
-
Measurements of abdominal anatomical structures,
-
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
-
Measurements of brightness ratio between liver and kidney,
-
Visualization of abdominal vascularization, microvascularization and perfusion,
-
Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-Color Flow Imaging, CPI-Color Power Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaye™ elastography and Strain Elastography.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on establishing substantial equivalence for the AIXPLORER® MACH 30 and AIXPLORER® MACH 20 Ultrasound Diagnostic Systems to predicate devices. It doesn't explicitly state numerical acceptance criteria in the format of a performance table like sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the new device performs at least as safely and effectively as the predicate devices and complies with relevant regulatory standards.
The device performance is demonstrated through compliance with a set of international and FDA-recognized standards and through a comparative engineering test.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with electrical, basic safety, essential performance, electromagnetic compatibility, and acoustic output standards. Biocompatibility of patient contact materials. | "All applicable electrical, basic safety and essential performance tests," "All applicable testing pertaining to electromagnetic compatibility," "All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment" (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37). "Yes, per ISO 10993-1" for patient contact materials. "Yes, as per NEMA UD-3" for acoustic output within FDA guidelines. |
| Effectiveness | Performance according to intended use for various clinical applications and imaging modes. Substantial equivalence in imaging modes and measurements, including new indications (Vi PLUS, Att PLUS, SSp PLUS, Strain Elastography). | "The Aixplorer® MACH Systems perform according to the stated intended use." "Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side." The device tables indicate "New" for Vi PLUS, Att PLUS, and SSp PLUS modalities, implying their successful implementation and functionality. |
| Labeling | Conformance to 21 CFR Part 801. | "Conforms to 21 CFR Part 801." |
| Quality System | Compliance with 21 CFR Part 820 and ISO 13485 (2016). | "The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention "test set" in the context of clinical images or patient data for evaluating AI performance. The studies described are primarily non-clinical engineering and regulatory compliance tests.
For the Strain Elastography engineering test, a specific sample size of cases or patients is not provided. It mentions a comparison "between Aixplorer® MACH and Mindray Resona 7," implying a technical evaluation rather than a clinical study with a patient cohort.
Data Provenance: Not applicable in the context of detailed clinical study data for AI performance. The regulatory compliance testing refers to international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the primary evidence cited is non-clinical engineering tests and adherence to standards, there is no mention of "experts" establishing ground truth for a clinical test set in the conventional sense of human readers. The "ground truth" for the engineering tests would be derived from the specifications and established performance of the predicate device and the physical principles verified by the tests themselves.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set with human readers and adjudication is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The submission focuses on establishing substantial equivalence to predicate devices for the ultrasound system itself and new indications, rather than the performance of AI-assisted interpretation by human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm-only performance study is explicitly mentioned. The "AIXPLORER® MACH" systems themselves perform diagnostic ultrasound imaging, and newer functionalities like "Vi PLUS," "Att PLUS," and "SSp PLUS" are described as features of the diagnostic system, not necessarily as standalone AI algorithms for image interpretation or diagnosis. The "engineering test of Strain Elastography" compares the device's technical output to a predicate, not an AI algorithm's diagnostic output.
7. The Type of Ground Truth Used
For the engineering tests and compliance studies, the "ground truth" is based on:
- Regulatory Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1. These standards define the acceptable technical and safety performance.
- Predicate Device Performance: The performance of the predicate ultrasound systems (AIXPLORER® MACH range sw V1, Aplio i900, i800, i700 V2.0, Resona 7) serves as the benchmark for "equivalence" in aspects like imaging modes and intended use.
- Physical Measurements and Quantitative/Qualitative Comparison: For the Strain Elastography test, the ground truth would be the known and verifiable measurements and output of the predicate Mindray Resona 7.
8. The Sample Size for the Training Set
No information about a training set for an AI/algorithm is provided. The document describes a medical device (ultrasound system) that relies on engineering principles and established imaging techniques, not a deep learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/algorithm is mentioned.
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(85 days)
Supersonic Imagine
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
-
Measurements of abdominal anatomical structures,
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Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
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Measurements of brightness ratio between liver and kidney,
-
Visualization of abdominal vascularization, microvascularization and perfusion,
-
Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
The provided document is a 510(k) Summary for the SuperSonic Imagine AIXPLORER® MACH Ultrasound Diagnostic Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing and clinical evaluation via literature review. No primary clinical study data with specific acceptance criteria and detailed performance metrics of the device are present in this document.
Therefore, many of your requested details cannot be extracted from this specific 510(k) summary as it does not contain a primary clinical study description with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case study data.
Here's a breakdown of what can be extracted and what information is not available from this document:
1. A table of acceptance criteria and the reported device performance
- Not Available. This document does not specify quantitative acceptance criteria for device performance nor does it report specific performance metrics from a clinical study for the AIXPLORER® MACH systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document states that a "clinical evaluation by literature route" was performed, indicating no new primary clinical test set was used for the AIXPLORER® MACH device for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. Since no new primary clinical test set was used, there is no information on experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. As no new primary clinical test set was used, no adjudication method is mentioned.
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 Available. This document does not describe an MRMC comparative effectiveness study. The AIXPLORER® MACH is an ultrasound diagnostic system and is not presented as an AI-assisted reading device in this context. The "AIXPLORER® MACH" name refers to the product family and not necessarily a specific AI algorithmic component for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. This document describes an ultrasound diagnostic system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. Since no new primary clinical study was conducted for this submission, no specific ground truth type is mentioned for a test set. The clinical evaluation relied on literature, implying that existing, previously established diagnostic methods or outcomes referenced in that literature would have served as de facto ground truth for those earlier studies.
8. The sample size for the training set
- Not Applicable / Not Available. This document describes the 510(k) clearance for an ultrasound diagnostic system, which is a hardware and software system for image acquisition and display, not a machine learning algorithm requiring a "training set" in the typical sense. Any internal algorithm development for image processing would not be detailed in this summary with specific training set sizes.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. See point 8.
Summary of available information regarding compliance and equivalence:
The document focuses on establishing substantial equivalence to previously cleared predicate devices:
Non-Clinical Testing:
Non-clinical testing was performed according to several international and FDA-recognized standards to support substantial equivalence:
- IEC 60601-1 Ed.3.1 (Electrical, basic safety, and essential performance)
- IEC 60601-1-2 Ed.4 (Electromagnetic compatibility)
- IEC 60601-2-37 Ed.2.1 (Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment)
- NEMA UD 2 (Rev. 3) (Acoustic Output Measurement Standard)
- NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- ISO 10993-1 (Biocompatibility)
The document states: "All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s)."
Clinical Evaluation:
A clinical evaluation was conducted "by literature route" to support substantial equivalence and to potentially expand the indications for use. This means existing scientific literature and studies related to similar ultrasound technologies and their clinical performance were reviewed, rather than conducting a new, dedicated clinical trial for the AIXPLORER® MACH systems themselves.
Conclusion stated in the document:
"The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3."
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(103 days)
Supersonic Imagine
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.
The SuperSonic Inagine AIXPLORER® & AIXPLORER® Utimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
Here's an analysis of the acceptance criteria and supporting studies for the AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining new, specific performance metrics with acceptance criteria for an AI component. The device is a general-purpose ultrasound system with several imaging modes, including ShearWave™ Elastography, and features for vascularization and perfusion.
The document states that a "clinical evaluation by literature route" was performed to support substantial equivalence and to widen the indications for use. This suggests reliance on existing published data about the performance of ultrasound systems with similar functionalities, particularly ShearWave™ Elastography, rather than a new performance study with predefined acceptance criteria.
Therefore, a table of acceptance criteria and reported device performance directly from a standalone AI study is not present in this document. Instead, the "reported device performance" is implicitly that the device is "at least as safe and effective as the predicate devices" based on non-clinical testing and clinical literature review.
However, the "Indications for Use" section (pages 2-14) outlines the specific capabilities of the AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems, particularly emphasizing:
- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen.
- Measurements of brightness ratio between liver and kidney.
- Visualization of abdominal vascularization, microvascularization and perfusion.
- Quantification of abdominal vascularization and perfusion.
These capabilities, particularly the ShearWave™ Elastography, visualization, and quantification of vascularization/perfusion, represent the "performance" that is being claimed as substantially equivalent to the predicate devices. The implicit acceptance criteria are that these functions operate within expected diagnostic ranges and provide information comparable to or better than the predicate devices, as supported by the literature review.
Specific Study Information from the Text:
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A table of acceptance criteria and the reported device performance:
As mentioned above, specific quantitative acceptance criteria or a direct performance table for a new AI feature is not provided. The entire submission focuses on establishing substantial equivalence to existing ultrasound devices (K171105, K170445, K160524) for its various imaging modes, including ShearWave™ Elastography and vascularization/perfusion features. The performance is validated indirectly through non-clinical testing against industry standards and a clinical literature review. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions a "clinical evaluation by literature route," which implies no specific new test set was generated for this submission. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a dedicated test set is not provided. The data would originate from the cited literature. -
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):
Since there was no specific new test set to establish ground truth for this submission, this information is not applicable and not provided in the document. The "ground truth" for the literary review would be inherent to the studies cited, established by the experts in those original publications. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new test set with human adjudication was created for this submission. -
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 is mentioned. The submission focuses on the device itself and its equivalence to other devices, not specifically on human reader improvement with AI assistance. The term "AI" is not explicitly used to describe the ShearWave Elastography or vascularization quantification features, although these advanced image analysis techniques often incorporate intelligent algorithms. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes an ultrasound system (hardware and software) used for diagnostic imaging, with features like ShearWave™ Elastography, vascularization visualization, and quantification. These are integrated functions of the device. There is no mention of a separate "algorithm only" performance study. The device, as a whole, performs these measurements and displays the results for interpretation by a human clinician. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "clinical evaluation by literature route," the ground truth would depend on the methodologies of the individual studies cited in the literature. These could include pathology, clinical follow-up, or expert consensus, but this document does not specify the type of ground truth used in the underlying scientific literature. -
The sample size for the training set:
As this is a premarket notification for device equivalence and not a submission detailing the development of a novel machine learning algorithm that requires a dedicated training set, no information about a training set size is provided. The device's algorithms for ShearWave™ Elastography, vascularization, and perfusion would have been developed and validated internally by the manufacturer, presumably using relevant data, but details about such training are not part of this 510(k) summary. -
How the ground truth for the training set was established:
Not applicable, as no training set information is provided in this regulatory submission.
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(89 days)
Supersonic Imagine
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, Doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems are indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pediatric, Urology, Trans-rectal, Transvaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate are a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI, and Angio PL.U.S), Pulsed Wave Doppler, 3D imaging and for ShearWave™ elastography.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a device relying on AI. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing. The "reported device performance" is implicitly that it meets the same safety and performance standards as the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Device Performance (Implicitly Met) |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Met |
| Performance (Technical) | Compliance with IEC 60601-2-37, NEMA UD 2, NEMA UD 3 | Met |
| Biocompatibility | Compliance with ISO 10993-1 | Met |
| Intended Use | Capability to perform listed applications | Met |
| Technological Equivalence | Similar imaging modes, controls, transducers, etc. | Met |
| Acoustic Output | Within FDA guidelines | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data is not required as the Aixplorer® and Aixplorer® Ultimate Systems use the same technology and principles as predicate devices." Therefore, no specific test set data (sample size or provenance) is provided for clinical performance, as a clinical study was not deemed necessary for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical test set was submitted for the purpose of demonstrating substantial equivalence, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no clinical test set was submitted, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an "Ultrasound Diagnostic System," which inherently involves a human operator to acquire and interpret images. While it includes "ShearWave™ elastography," which might involve some algorithmic processing, the document does not describe a standalone algorithm-only performance study for an AI component in isolation. The focus is on the integrated system.
7. Type of Ground Truth Used
Given that clinical data was not required for this submission, no specific ground truth (e.g., pathology, outcomes data, expert consensus) was referenced for a clinical study. The "ground truth" implicitly relied upon is the established safety and performance characteristics of the predicate ultrasound devices and the adherence of the new device to relevant international technical standards.
8. Sample Size for the Training Set
As there's no mention of an AI algorithm requiring a training set in the context of this 510(k) summary for clinical performance, no information on the sample size for a training set is provided. The submission focuses on device hardware and software equivalence to existing ultrasound technology.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of AI development for clinical performance, there is no information on how its ground truth would have been established.
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(119 days)
SUPERSONIC IMAGINE
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.
This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® Ultrasound Diagnostic System, indicating that clinical data was not required for its clearance because it uses the same technology and principles as its predicate devices. Therefore, the document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria derived from a human-in-the-loop or standalone AI performance study.
Specifically, section 8 of the summary (page 24) explicitly states: "Clinical data is not required as the Aixplorer® System uses the same technology and principles as predicate devices."
As a result, I cannot provide the requested information, which would typically be found in a clinical study report for an AI/ML medical device. This 510(k) submission is for a conventional ultrasound system, not an AI-powered diagnostic device in the way a modern AI/ML submission would be.
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(111 days)
SUPERSONIC IMAGINE
The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications: Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Neonatal/ Adult Cephalic, Fetal/Obstetrics).
The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
The provided text is a 510(k) Pre-market Notification for the SuperSonic Imagine Aixplorer® Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended uses and various transducers. Crucially, this document does not contain information about acceptance criteria or a study proving the device directly meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).
Instead, the document asserts substantial equivalence based on technological characteristics and compliance with general safety and performance standards. It explicitly states that clinical data is not required because the device uses the same technology and principles as predicate devices.
Therefore, many of the requested sections about acceptance criteria and performance studies cannot be filled from this document. However, I can extract information regarding non-clinical tests and the general nature of the device's validation.
Here's a breakdown based on the available information:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria are adherence to various electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility standards. For instance, acoustic output must be "within FDA guidelines" as per NEMA UD-3.
- Reported Device Performance: The document states that "All data fell within pre-determined product specifications and external standard requirements." However, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as diagnostic performance studies were not conducted or submitted for this specific 510(k). The performance is described in terms of its ability to operate in various imaging modes (B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, etc.) and for various clinical applications, which are identical or similar to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| IEC 60601-1 3rd Edition (Electrical, basic safety) | All applicable tests confirmed compliance. |
| UL 60601-1 1st Edition (Electrical, basic safety for USA) | All applicable tests confirmed compliance. |
| IEC 60601-1-2 3rd Edition (Electromagnetic compatibility) | All applicable tests confirmed compliance. |
| IEC 60601-2-37 2nd Edition (Safety for ultrasonic medical devices) | All applicable tests confirmed compliance. |
| NEMA UD 2 (Rev. 3) (Acoustic Output Measurement) | Demonstrated compliance with the standard. |
| NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices) | Demonstrated compliance with the standard. |
| ISO 10993-1 (Biocompatibility) | Applicable tests performed per FDA 510(k) Memorandum - #G95-1. |
| Stated Intended Use (Imaging modes and clinical applications) | Performs according to the stated intended use. |
| New Transducers (XP5-1 and SLH20-6) Performance | Performance tests conducted and confirmed adherence to specifications. |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided regarding a sample size for a test set related to diagnostic performance, as clinical studies were not submitted.
- Non-clinical testing of the device and new transducers was performed, but no specific "test set" in terms of patient data is mentioned. The testing was likely conducted in a lab environment in France (where SuperSonic Imagine is based).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical studies with a test set requiring ground truth establishment by experts were submitted.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical studies with a test set requiring adjudication were submitted.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/CADe device. No MRMC study was mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/CADe device. No standalone algorithm performance was discussed.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for diagnostic performance. For non-clinical tests, "ground truth" would be the specific requirements of the mentioned standards (IEC, UL, NEMA, ISO).
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The sample size for the training set
- Not applicable. This is not an AI/CADe device, and no training set is mentioned.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/CADe device, and no training set is mentioned.
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