Search Results

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

The provided FDA 510(k) summary for GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC's EchoPAC Software Only/EchoPAC Plug-in includes an "AI Summary of Testing" section for the Easy Auto EF and Easy AFI LV algorithms. This section provides information relevant to acceptance criteria and study details.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance figures, as they state the accuracy achieved.

Note: The document only provides Dice score for "accuracy." Other common performance metrics like sensitivity, specificity, or F1-score are not explicitly stated.

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

• Sample Size for Test Set:
  • Individual patients' images: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization).
  • Number of samples (images): 135 images extracted from the 45 exams.
• Data Provenance: Europe, Asia, US (retrospective, as indicated by anonymization and collection for testing).

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

• Number of Experts: Two certified cardiologists initially, with a panel of experienced experts for adjudication.
• Qualifications of Experts:
  • Two certified cardiologists (for initial manual delineation and review).
  • A panel of experienced experts (for reviewing annotations that the two cardiologists could not agree on). Specific years of experience are not mentioned beyond "experienced."

4. Adjudication Method

The adjudication method used was a 2+1 process (consensus followed by expert panel review):

1. Consensus Reading: Two certified cardiologists performed manual delineation and then reviewed each other's annotations. They discussed disagreements to reach a consensus.
2. Expert Panel Review: If the two cardiologists could not agree on an annotation, a panel of experienced experts further reviewed those annotations to establish the final ground truth.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the standalone performance of the AI algorithm. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm-only without human-in-the-loop performance) study was done. The reported Dice scores directly evaluate the algorithm's accuracy in segmenting regions of interest, independent of human interaction during the measurement process.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus. It was derived from manual delineations by certified cardiologists, with a further review and consensus by an expert panel for disagreements.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions that "datasets from different clinical sites for testing as compared to the clinical sites for training" were used.

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

The document does not explicitly state how the ground truth for the training set was established. It only describes the process for the test set's ground truth. However, it is generally assumed that similar expert-driven annotation processes would have been used for training data.

Ask a specific question about this device

Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USBadapter) connection.

The provided text focuses on the 510(k) premarket notification for the GE Vivid S60N/S70N ultrasound system. It details device descriptions, intended use, technological characteristics, and non-clinical tests. Crucially, it includes information on the "AI Summary of Testing: Easy Auto EF and Easy AFI LV," which addresses the performance of the AI algorithms incorporated into the device.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Study that Proves Device Meets Acceptance Criteria

The document states that the acceptance criterion for the AI algorithms (Easy Auto EF and Easy AFI LV) is an average dice score of 91% or higher across various testing conditions.

Study Proving Device Meets Acceptance Criteria:

The study involved testing the AI algorithms on datasets from different countries, scanning views, and left ventricle volumes.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The text states "92% or higher" and "91% or higher" for the reported performance, implying the acceptance criterion was at least 91%.

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

• Sample Size: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization). 135 images extracted from the 45 exams.
• Data Provenance:
  • Country of Origin: Europe, Asia, US (mixed data from different countries).
  • Retrospective/Prospective: Not explicitly stated, but the description of "data collection protocol was standardized across all data collection sites" and "During testing of the AI algorithm, we have included images from different countries..." suggests a pre-existing collected dataset, making it likely retrospective.

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

• Number of Experts:
  • Initial Delineation and Review: 2 certified cardiologists.
  • Consensus Review: A panel of experienced experts.
• Qualifications of Experts:
  • "Certified cardiologists" (for initial delineation and review).
  • "Experienced experts" (for the consensus review panel). Specific number of years of experience is not provided, but "certified" and "experienced" imply relevant qualifications.

4. Adjudication Method for the Test Set:

• Method: A multi-stage adjudication process was used:
  1. Two certified cardiologists performed manual delineation.
  2. They then reviewed each other's annotations.
  3. A "consensus reading" was performed where the two cardiologists discussed agreement/disagreement.
  4. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
• The final ground truth relied on annotations that the two cardiologists agreed upon, and the consensus annotations achieved by the expert panel.

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

• No MRMC comparative effectiveness study was done. The information provided focuses on the standalone performance of the AI algorithm (Easy Auto EF and Easy AFI LV) in terms of Dice score accuracy for image segmentation, not on reader performance with or without AI assistance.

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

• Yes, a standalone performance evaluation of the AI algorithm was done. The reported "average dice score" is a metric for the algorithm's performance in automatically segmenting cardiac structures (Left Ventricle volume). The study describes the AI's accuracy in delineating these structures.

7. The Type of Ground Truth Used:

• Expert Consensus. The ground truth was established through manual delineation by certified cardiologists, followed by their mutual review, and a final consensus adjudicated by a panel of experienced experts.

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. The document only mentions that "To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training." This implies a training set existed and was distinct, but its size is not given.

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

• Not explicitly stated in the provided text. While the method for establishing ground truth for the test set is detailed, the process for the training set is not described. It is implied that ground truth was established, as AI models require labeled data for training, but the specific methodology is omitted.

Ask a specific question about this device

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinical applications include: abdominal (GYN and Urology), thoracic pleural, ophthalmic. Fetal/OB. Small Organ (including breast, testes, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid dramage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: BM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Fit is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analvsis. The Venue Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning. The Venue Fit utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. Venue Fit is capable of wired or wireless internet connection. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve feature)

Note: The document does not provide specific performance percentages against the 70% and 80% thresholds. It states that success criteria were based on conformance to ground truth and that preliminary surveys identified appropriate thresholds for pixel and frame accuracy for the intended use.

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

• Sample Size:
  • Sequences: 124 sequences
  • Frames: 3776 frames
  • Individuals: 44 individuals
• Data Provenance: USA, Japan, Israel (Retrospective, as it was a pre-existing dataset used for verification)

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

• Number of Experts: A single clinical expert.
• Qualifications of Experts: "clinical expert" - further specific qualifications (e.g., years of experience, specialty) are not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: None explicitly stated. Ground truth annotations were performed by a single clinical expert.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The testing focused on the standalone performance of the cNerve feature.

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

• Yes, a standalone study was performed. The "AI Summary of Testing" directly addresses the performance of the cNerve algorithm against ground truth annotations.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single clinical expert) on anatomical areas of nerve bundles within individual frames.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only states that the data used for verification is "completely distinct" from the training data.

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

• The document does not specify how the ground truth for the training set was established. It only ensures that the verification data was distinct from the training data.

Ask a specific question about this device

The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harnonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging. measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document describes the FDA 510(k) premarket notification for the GE Medical Systems Venue diagnostic ultrasound system. While the primary focus of the document is on establishing substantial equivalence to a predicate device, it also includes an "AI Summary of Testing" specifically for a feature called "cNerve." This summary provides some details about the cNerve feature's acceptance criteria and performance evaluation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, focusing on the cNerve feature.

Acceptance Criteria and Study for cNerve Feature

The cNerve feature is designed to "detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Individuals: A total of 44 individuals.
  • Sequences: 124 sequences. Each individual contributed up to 2 sequences per view location, often from both laterals (left and right).
  • Frames: 3776 frames.
• Data Provenance: Retrospective, collected from "USA, Japan, Israel."

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

• Number of Experts: A single clinical expert.
• Qualifications: "A single clinical expert" - specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: "None" explicitly mentioned. Ground truth annotations were "obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame." This indicates a single-expert annotation without a specified adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for the cNerve feature in this summary. The AI testing described focuses on standalone algorithm performance against a single expert's ground truth.

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

• Standalone Performance: Yes. The "AI Summary of Testing" describes the evaluation of the cNerve feature's "accuracy" based on its detections conforming to ground truth annotations. The acceptance criteria heavily focus on the algorithm's ability to meaningfully and successfully detect nerves in sequences and frames, suggesting a standalone performance evaluation.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single expert). The ground truth was established by "a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified in the provided document. The summary only mentions that the "data used for verification is completely distinct from that used during training process and there is no overlap between the two."

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

• Training Set Ground Truth Establishment: Not specified in the provided document. The summary only states that the training data and verification data are distinct.

Ask a specific question about this device

The Venue Go is a general purpose diagnostic ultuse by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time. The Venue Go utilizes a varietv of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically.

The provided document is a 510(k) Premarket Notification Submission for the GE Venue Go ultrasound system. It includes a specific section detailing the AI feature cNerve. Based on this information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve AI Feature)

Important Note: The document outlines the acceptance criteria for cNerve but does not explicitly provide the measured numerical performance results of the device against these criteria. It states that the "cNerve performance requirements" are listed but does not follow up with a section detailing the actual tested performance numbers.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Individuals): A total of 44 individuals contributed to the verification dataset.
• Sample Size (Sequences/Frames): The test dataset included 124 sequences and 3776 frames.
• Relationship between Samples: Each individual contributed up to 2 sequences per view location (often both left and right laterals were scanned).
• Demographic Distribution:
  • Gender: Male and Female
  • Age: 18-82 years
  • Ethnicity/Country: USA, Japan, Israel
• Subgroups Tested: The algorithm performance was verified via frame accuracy on all demographic subgroups: Gender (M/F), Age (=60), BMI (25). It was also tested for all supported nerve block locations and supported probe types.
• Data Provenance: The document implies the data was collected from a mix of clinical settings (implied by "USA, Japan, Israel" for ethnicity/country) and clinical scenarios ("all supported nerve block locations and all supported probe types"). The study type (retrospective or prospective) is not explicitly stated, but the process of collecting and annotating an existing dataset suggests a retrospective approach for the dataset creation for validation.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A single clinical expert annotated the frames from scouting sequences.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, specific specialty like "radiologist") of the "single clinical expert" are not detailed in the provided text.

4. Adjudication Method for the Test Set

• The ground truth was established by a single clinical expert. Therefore, there was no adjudication method described (e.g., 2+1, 3+1 concensus), as only one expert was involved in marking the ground truth.

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs without AI assistance. The study focuses solely on the standalone performance measurement of the cNerve algorithm against defined ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "AI Summary of Testing" section describes the evaluation of the cNerve algorithm's accuracy, focusing on its ability to detect and track nerve bundles independently. The acceptance criteria ("Sequence accuracy requirement - for testing overall cNerve performance") explicitly relate to the algorithm's performance.

7. Type of Ground Truth Used

• The ground truth used was expert annotation/consensus (from a single expert). The frames were "annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document explicitly states: "The data used for verification is completely distinct from that used during training process and there is no overlap between the two." However, it does not disclose details about the training data itself.

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

• The document does not describe how the ground truth for the training set was established. It only mentions that the test data was distinct from the training data.

Ask a specific question about this device

LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.

The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor (OLED and HDU monitors). The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.

The provided text focuses on the 510(k) premarket notification for the GE Healthcare LOGIQ E10 ultrasound system. It primarily discusses the device's indications for use, its technical characteristics, and its comparison to predicate devices to demonstrate substantial equivalence.

Crucially, the document explicitly states in the "Summary of Clinical Tests" section:

"The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence."

This statement means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available within this document, as no clinical studies were performed or required for this 510(k) submission.

Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document's purpose is to demonstrate substantial equivalence to a legally marketed predicate device through non-clinical data, rather than presenting a clinical study of the device's efficacy or performance against specific clinical acceptance criteria.

Ask a specific question about this device

The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/ PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.

The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 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 high- resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or an optional 22-inch color OLED widescreen monitor).

The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).

The provided text is a 510(k) Premarket Notification from the FDA for GE Healthcare's LOGIQ E10s and LOGIQ Fortis diagnostic ultrasound systems. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific clinical studies with acceptance criteria, sample sizes, or ground truth establishment in the way typically found for AI/ML-driven medical devices that require such studies for de novo or PMA applications.

Therefore, most of the requested information cannot be extracted from this document as it explicitly states: "The subject of this premarket submission, LOGIQ E10s, LOGIQ Fortis, did not require clinical studies to support substantial equivalence."

However, I can provide available information:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for clinical applications. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing intended use, technology, imaging modes, safety, and functionality.

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

Not applicable. The document states that clinical studies were not required.

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

Not applicable. The document states that clinical studies were not required.

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

Not applicable. The document states that clinical studies were not required.

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 document states that clinical studies were not required, and this device is primarily a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

Not applicable. The document states that clinical studies were not required. This device is a diagnostic ultrasound system operated by a human.

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

Not applicable. The document states that clinical studies were not required.

8. The sample size for the training set:

Not applicable. The document states that clinical studies were not required. This is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific training set with ground truth in the context described.

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

Not applicable. The document states that clinical studies were not required.

Ask a specific question about this device

Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The provided document is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid S60N / Vivid S70N diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that would define acceptance criteria and prove its fulfillment.

Therefore, the requested information elements related to detailed study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.

The document explicitly states: "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence."

This indicates that clinical studies, which would typically involve the kind of detailed performance metrics, acceptance criteria, and study methodology you're asking about, were not conducted or submitted for this particular premarket notification. The submission relies instead on demonstrating equivalence to legally marketed predicate devices based on technological characteristics and non-clinical testing.

Therefore, I cannot provide a table of acceptance criteria or a study that proves the device meets those criteria based on the provided text.

Here's what information I can extract regarding the device and the nature of the submission:

• Device Name: Vivid S60N / Vivid S70N Diagnostic Ultrasound System
• Regulation Number: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system)
• Regulation Name: Ultrasonic pulsed doppler imaging system
• Regulatory Class: Class II

Elements that cannot be provided from this document:

1. Table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study was 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 study was conducted.
4. Adjudication method for the test set: Not applicable as no clinical study was conducted.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no standalone algorithm performance study was mentioned.
7. The type of ground truth used: Not applicable as no clinical study was conducted.
8. The sample size for the training set: Not applicable as no clinical study data for training was mentioned.
9. How the ground truth for the training set was established: Not applicable as no clinical study data for training was mentioned.

This 510(k) submission primarily addresses the substantial equivalence of the Vivid S60N / Vivid S70N to its predicate and reference devices by outlining:

• Its intended use and indications for use.
• Its technological characteristics.
• Non-clinical testing for safety and performance (acoustic output, biocompatibility, cleaning, electrical, electromagnetic, mechanical safety, and compliance with various standards like IEC 60601 series, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 DICOM).
• Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing).

Ask a specific question about this device