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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs(thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800, and Aplio i700 Model TUS-Al700, V5.1 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

The provided text does not contain specific acceptance criteria or details of a study explicitly proving the device meets acceptance criteria in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC thresholds). Instead, it describes a substantial equivalence submission for an ultrasound system, focusing on comparing its features and performance with predicate devices.

However, based on the information provided, I can infer the "acceptance criteria" and the "study" in a broader sense of device performance validation, particularly regarding changes and new features.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance for Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1

The submission focuses on establishing substantial equivalence for an updated ultrasound system (Software V5.1). The "acceptance criteria" can be broadly interpreted as ensuring that the new and improved features perform as intended and/or are substantially equivalent to existing features or predicate devices, without introducing new safety or effectiveness concerns.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "bench testing and clinical evaluation" and "additional performance testing, using test data and volunteer studies." However, it does not provide specific sample sizes for these test sets, nor does it specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The "LI-RADS Checklist" and "Workflow Navigator" features reference ACR and ASE guidelines, implying expert consensus underlies these guidelines, but not directly for validating the device's implementation.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating device performance in a multi-expert setting.

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

The document does not report a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance, nor does it provide any effect size for such a comparison. The device is a diagnostic ultrasound system, and while it has "smart" features, it's not presented as an AI-assisted diagnostic tool that directly impacts human reader interpretation in a comparative effectiveness study as typically found for CADe/CADx devices.

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

The document does not provide specific standalone performance metrics (e.g., sensitivity, specificity, AUC) for any of its "smart" or improved features. The description focuses on functionality, workflow improvement, and image quality enhancements within the context of a diagnostic ultrasound system used by a clinician.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for evaluating the device's performance. The nature of an ultrasound system update suggests that ground truth would likely be established through:

• Clinical observation/expert assessment: For image quality, workflow efficiency, and visualization improvements.
• Conformance to guidelines: For features like the LI-RADS Checklist (ACR guidelines) and Workflow Navigator (ASE guidelines).
• Technical specifications/measurements: For aspects like processing speed (iBeam+), resolution (Sensor 3D), and detection range (SMI G4).

8. Sample Size for the Training Set:

This information is not provided in the document. As this is an ultrasound system submission focusing on feature updates and substantial equivalence, the concept of a "training set" in the context of machine learning for novel AI algorithms is not explicitly addressed in the provided summary. While "Smart Fetal Heart," "Smart Optimization," and "SMI G4" might incorporate machine learning components, no details on their training are given.

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

This information is not provided in the document, as no details about a "training set" or its ground truth establishment are mentioned.

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Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

Standalone software product with Primary Operating Functions:
• Display and editing of GE Ultrasound 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Small Parts, Pediatrics, Musko-Skeletal (MSK)
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM®1)
• Adding annotations to acquired image

This document describes the 510(k) premarket notification for GE Medical Systems Ultrasound and Primary Care Diagnostics' 4D View device. The 4D View is a software product intended for image display of GE Ultrasound 3D/4D datasets for diagnostic purposes, including measurements.

The submission claims substantial equivalence to its predicate device, 4D View (K131118), and references Voluson E10 (K172342). As the submission explicitly states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Based on the provided text, the following information can be extracted regarding the device and its assessment for substantial equivalence.

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

Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission are based on demonstrating substantial equivalence to the predicate device in terms of:

The document states that the proposed 4D View adds workflow improvements and improvements to archive and DICOM functionality, implying performance enhancements in these areas compared to the predicate, but no quantitative metrics are given.

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

Not applicable, as no clinical studies with a test set were conducted.

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 studies with a test set were conducted.

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

Not applicable, as no clinical studies with a test set were conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The 4D View is described as a standalone software product primarily for displaying and measuring GE Ultrasound 3D/4D datasets. There is no mention of "AI" or a human-in-the-loop component that would require an MRMC study to assess reader improvement with AI assistance.

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

While the device is a "standalone software product," the documentation does not describe a performance study for the algorithm without human-in-the-loop. The substantial equivalence is based on the device's functional and technological similarities to the predicate, not on a standalone performance study against a clinical ground truth.

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

Not applicable, as no clinical studies were conducted that required establishing a clinical ground truth for performance evaluation.

8. The sample size for the training set:

Not applicable, as this device's submission does not describe an AI/machine learning model development process that would involve a training set.

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

Not applicable, as this device's submission does not describe an AI/machine learning model development process.

Summary of Non-Clinical Tests Used for Substantial Equivalence:

The primary evidence for substantial equivalence for the 4D View device came from non-clinical tests and a comparison to its predicate device. These included:

• Compliance with voluntary standards:
  • ISO 14971:2007 (Risk Management)
  • NEMA PS 3.1 -3.20 (DICOM standards)
  • IEC 62304:2006 (Medical device software life cycle process)
• Quality assurance measures applied during development:
  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Performance testing (Verification)

The manufacturer concluded that the proposed 4D View is as safe, as effective, and its performance is substantially equivalent to the predicate devices based on these non-clinical assessments and the functional comparison.

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The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HERA W10 is general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode. M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W10 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

I am sorry, but the provided text does not contain sufficient information to answer your request. The document is a 510(k) summary for the HERA W10 Diagnostic Ultrasound System, which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended uses and compliance with safety standards.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes used for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set or how its ground truth was established.

In fact, section 11 explicitly states: "The subject of this premarket submission, HERA W10, did not require clinical studies to support substantial equivalence." This indicates that detailed performance studies as you've requested were not part of this specific FDA submission.

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The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

The provided text is a 510(k) summary for the Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1. It describes the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted. However, the document does not describe a study involving human readers or AI assistance to improve human reader performance. It focuses solely on the device's technical capabilities and its equivalence to other cleared devices. Therefore, I cannot provide details on MRMC studies or human reader improvement with AI assistance based on this document.

For the aspects that are covered, here is the information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document describes performance testing for several features, primarily focusing on proving substantial equivalence to predicate devices and meeting specifications. Specific numerical acceptance criteria are not explicitly detailed in this summary, but the reported device performance implies that the features met specifications and performed as intended.

2. Correct quantitative measurement results (Velocity and Direction). | 1. Color mapping image depicted correctly in terms of spatial distribution of moving bubbles using a wire phantom and test data.
3. Quantitative measurement results (Velocity and Direction) obtained correctly using a string phantom, a flow phantom, and test data. |
   | Breast Scan Guide | Correct display of locational information of an object of interest in the X-ray image (matching breast body mark location in ultrasound with lines calculated from X-ray image locational data). | Correctly displays the locational information of an object of interest in the X-ray image, specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from the X-ray image. |
   | 3D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | Smart Fusion | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2nd Console | Meeting specifications and performing as intended. | Met specifications and performed as intended. |

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

The document mentions "test data phantom and in a clinical evaluation" for Limb Volume Measurement, and "a wire phantom and test data" or "a string phantom, a flow phantom and test data" for Contrast Vector Imaging. However, specific sample sizes for these test sets are not provided. The provenance of the "clinical data" / "test data" and "volunteer studies" is not specified (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts to establish ground truth for the described performance tests. The testing appears to rely on physical phantoms and "test data" which would likely have inherent or pre-defined ground truth based on their construction or known properties, or clinical data where the "truth" is established by the device's calculations or outputs being compared against an expected outcome or another measurement method.

4. Adjudication Method for the Test Set:

No information regarding adjudication methods (e.g., 2+1, 3+1, none) is provided. This type of information is usually relevant for studies involving human readers or subjective interpretations, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done according to the provided text. The document describes technical performance testing and "clinical evaluation" but no studies involving human readers evaluating the device's impact on their performance, either with or without AI assistance. The submission focuses on device functionality and substantial equivalence.

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

The performance testing described ("correctly calculated", "depicted correctly", "obtained correctly") relates to the device's algorithmic performance in specific modes and features using phantom and possibly clinical data. This would fall under standalone performance assessment, as it's evaluating the device's output directly against a known or expected result, rather than a human's interpretation.

7. The Type of Ground Truth Used:

The ground truth for the tests described appears to be:

• Physical Phantoms: For Limb Volume Measurement (test data phantom), Contrast Vector Imaging (wire phantom, string phantom, flow phantom). These phantoms are designed with known properties or simulated conditions that serve as ground truth.
• Expected Results/Specifications: For the calculations and depictions, and for the improvements to existing features, the "ground truth" is implied to be that the device's output matches its design specifications and performs as intended.
• Clinical Data: Used in conjunction with phantoms for Limb Volume Measurement. The nature of the ground truth within this clinical data (e.g., pathology, clinical outcomes, or another validated measurement method) is not explicitly stated, but it would logically be a reference standard for the values being calculated (fractional limb volume, EFW).
• X-ray Image Data: For Breast Scan Guide, the locational information from the X-ray image serves as the ground truth against which the ultrasound system's display of the breast body mark is compared.

8. The Sample Size for the Training Set:

The document is a 510(k) summary for an ultrasound system, not explicitly an AI/ML device per se, although it does mention "Smart Navigation" and "Smart 3D". It outlines performance testing for new and improved features and transducer models rather than a specific AI algorithm. As such, the document does not provide information on the sample size of a training set as it is not discussing the development of an AI model.

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

As no training set is discussed or implied to exist for a specific AI algorithm in this Preamarket Notification summary, no information on how ground truth for a training set was established is provided.

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The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatic and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided text is related to a 510(k) premarket notification for the GE Healthcare Voluson P6 and Voluson P8 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through clinical studies.

Therefore, the document explicitly states: "The subject of this premarket submission, Voluson P6 / Voluson P8, did not require clinical studies to support substantial equivalence."

This K-submission demonstrates equivalence based on:

• Identical Intended Use: The Voluson P6/P8 has the same general-purpose ultrasound system indications for use as the previously cleared predicate (K160162 Voluson P Series; Voluson P6/P8 Diagnostic Ultrasound System).
• Similar Technology: It employs the same fundamental scientific technology.
• Comparison to Predicates: The systems are determined to be substantially equivalent in intended use, imaging capabilities, technological characteristics, safety, and effectiveness. This includes having the same clinical intended use, imaging modes, identical transducers, same indications for use, similar capabilities in measurements, digital image capture, review, and reporting.
• Compliance with Safety Standards: The device has undergone non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conforms to applicable medical device safety standards. It also complies with voluntary standards like AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, and NEMA PS 3.1 - 3.20 (DICOM).
• Quality Assurance Measures: The development included risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, and safety testing.
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.

Since no clinical studies were performed, there is no information available in this document to populate the following requested sections:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics for clinical accuracy are provided as clinical studies were not required. Acceptance criteria would primarily relate to safety and functionality matching the predicate device.
2. Sample sizes used for the test set and the data provenance: No test set of clinical images/data was used for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth was established from experts for a clinical test set.
4. Adjudication method: Not applicable as no clinical images were adjudicated.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no mention of an algorithm or training set for clinical performance.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) premarket notification for a general-purpose ultrasound system. Its "acceptance criteria" for FDA clearance are primarily based on demonstrating substantial equivalence to existing devices through non-clinical testing and shared intended use, not on specific performance metrics derived from clinical studies or AI algorithm validation.

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The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal / Obstetrics; Abdominal (including renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (includes urology/prostate); Transvaginal (includes infertility monitoring of follicle development).

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

This document describes the GE Healthcare Voluson S8/S10/S10 Expert ultrasound system and its equivalence to predicate devices, but it does not provide acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for AI/ML performance evaluation.

Instead, this is a 510(k) premarket notification summary from the FDA, focusing on:

• Substantial Equivalence: Comparing the new device to existing legally marketed devices (predicates).
• Safety and Effectiveness: Ensuring the device meets recognized safety standards and performs as intended.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a table of numerical acceptance criteria or reported specific device performance metrics for AI/ML algorithms as typically seen in studies evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, it asserts "substantial equivalence" to predicate devices, meaning its performance characteristics are deemed similar enough that it doesn't raise new questions of safety or effectiveness. The "performance" discussed is related to its ability to perform diagnostic ultrasound imaging and fluid flow analysis, offering various imaging modes, and complying with safety standards.

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

• Sample Size for Test Set: Not applicable / Not provided. This document specifies that "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no specific test set of patient data was used for performance evaluation of new AI/ML features in what would typically be considered an AI/ML clinical study.
• Data Provenance (country of origin, retrospective/prospective): Not applicable / Not provided.

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

• Number of Experts: Not applicable / Not provided. Since clinical studies for substantial equivalence were not required, there was no separate ground truth establishment process involving external experts for performance evaluation. The ground truth for general ultrasound imaging is established through standard medical practice and expert interpretation.
• Qualifications of Experts: Not applicable / Not provided specifically for this submission.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable / Not provided. No specific test set performance evaluation was described.

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

• MRMC Study Done: No. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable / Not provided.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done: No. The document states that clinical studies were not required. The "improved version of existing software feature IOTA LR2 model called IOTA Simple Rules," "3D Analysis feature of the endometrial cavity called SonoMetrium," "enhanced feature of existing software feature HDlive called HDlive Silhouette," and "enhanced feature of existing software feature SRI called VSRI" are mentioned as being "previously cleared with K172342" or are enhancements of existing features. This indicates that these features were likely evaluated in the context of substantial equivalence to previous versions or predicate devices, rather than as new standalone AI detections requiring their own independent performance studies for this specific submission.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated or required for this type of submission. For ultrasound imaging systems, ground truth is typically established by medical professionals through established diagnostic protocols, expert interpretation, and potentially correlation with other diagnostic modalities or pathology where applicable. However, no specific ground truth was established for a new clinical performance study for this submission.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable / Not provided. As this submission focuses on substantial equivalence of an ultrasound system and enhancements to existing software features, specific AI model training data sizes are not detailed in this regulatory document.

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

• How Ground Truth Was Established: Not applicable / Not provided.

Summary of AI/ML Specifics from the Document:

The document mentions several "improved" or "enhanced" software features that could potentially involve AI/ML components (e.g., IOTA Simple Rules, SonoMetrium, HDlive Silhouette, VSRI, Radiantflow). However, for this specific 510(k) submission (K180374), these features are explicitly stated to be either:

• "previously cleared with K172342" (a reference predicate).
• "an improved version of existing software feature" or "an enhanced feature of existing software feature."

This implies that the novelty of these features for this particular submission was not in their initial safety and effectiveness evaluation as new AI/ML tools, but rather in their inclusion or minor enhancement within the Voluson S8/S10/S10 Expert system, aligning with existing predicate clearances. Therefore, detailed performance studies for these specific AI/ML components are not provided within this document, as they were likely addressed in previous clearances (like K172342 for the Voluson E Series).

Conclusion: This document is a 510(k) premarket notification for an ultrasound system, demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not contain the detailed AI/ML specific acceptance criteria or performance study data that you requested, as the submission strategy relied on substantial equivalence rather than novel clinical performance data for new AI/ML features.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client-server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) premarket notification for a medical device called "ViewPoint 6." This document primarily discusses the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical tests performed to ensure compliance with relevant standards.

Specifically, the document states: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." This means that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used for ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).

The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch LCD touch screen and color widescreen monitor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LOGIQ E10 device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. The document explicitly states that "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be limited, primarily referencing the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a diagnostic ultrasound system, the "acceptance criteria" are implied to be that the new device performs "as safe, as effective, and its performance is substantially equivalent to the predicate device(s)" (as stated in the conclusion). Specific quantitative acceptance criteria for image quality or diagnostic accuracy are not provided in this document, as clinical studies were not required. The performance is assessed by comparison to the established performance of the predicate devices.

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

No specific test set or associated sample size is mentioned for a clinical performance study since none was required. The "testing" referred to in the document is primarily non-clinical, focusing on engineering verification and validation against technical standards and comparisons to existing predicate devices.

• Sample Size for Test Set: Not applicable, as no clinical test set was used/required for performance evaluation.
• Data Provenance: Not applicable for clinical test data. Non-clinical data would originate from internal GE Healthcare testing.

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

Not applicable, as no clinical test set was required, and thus no ground truth established by experts for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was required.

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

Not applicable. The device described, LOGIQ E10, is a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device for image interpretation that would typically necessitate an MRMC study comparing human reader performance with and without AI assistance. The document focuses on the capabilities of the ultrasound system itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The LOGIQ E10 is a diagnostic ultrasound imaging system; its "performance" is inherently tied to image acquisition and display, which is then interpreted by a human physician. It is not an algorithm designed for standalone diagnostic output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable for clinical performance studies. For non-clinical (engineering) verification, ground truth would be established through defined engineering specifications, phantom measurements (for acoustic output), and compliance with recognized standards.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/Machine Learning device that requires a training set for algorithm development.

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

Not applicable, as this is not an AI/Machine Learning device.

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