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510(k) Data Aggregation
(89 days)
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, 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 T9/Vivid T8 consists of a mobile console with 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, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
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.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
The GE Vivid T8/Vivid T9 ultrasound system includes AI algorithms named Easy Auto EF and Easy AFI LV. The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Easy Auto EF and Easy AFI LV) |
|---|---|
| Average Dice Score (overall) | 92% or higher |
| Average Dice Score (different scanning views) | 91% or higher |
| Average Dice Score (different left ventricle volumes) | 92% or higher |
2. Sample Size Used for the Test Set and Data Provenance
- Number of Individual Patients' Images: 135 images
- Number of Exams: 45 exams (assumed 45 patients, exact number of patients unknown due to anonymization)
- Data Provenance:
- Country of Origin: Europe, Asia, US
- Retrospective/Prospective: Not explicitly stated, but implies retrospective collection from various clinical sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Initial Ground Truth Establishment: Two certified cardiologists.
- Adjudication Panel: A panel of experienced experts. Specific number and years of experience not provided, beyond "experienced experts."
4. Adjudication Method for the Test Set
The adjudication method appears to be a 2 + 1 method (or similar consensus-based approach):
- Two certified cardiologists performed manual delineation and reviewed each other's annotations.
- A consensus reading was conducted where the two cardiologists discussed their agreement.
- For annotations where the two cardiologists could not agree, a panel of experienced experts further reviewed and established the consensus.
- The final ground truth comprised annotations agreed upon by the two cardiologists, and the consensus annotations from the expert panel review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. The document focuses on the standalone performance of the AI algorithm.
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 conducted, specifically measuring the accuracy (Dice score) of the AI algorithm(s) against an established ground truth.
7. The Type of Ground Truth Used
The ground truth used was expert consensus. It was established through a multi-step process involving initial independent delineation by two certified cardiologists, their consensus discussions, and further review by a panel of experienced experts for disagreements.
8. The Sample Size for the Training Set
The document does not provide the sample size for the training set. It only states that the testing dataset was independent of the training data.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the testing dataset was ensured to be independent from the training data by using datasets from "different clinical sites for testing as compared to the clinical sites for training."
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(96 days)
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)
| Acceptance Criteria (cNerve) | Reported Device Performance (cNerve) |
|---|---|
| Sequence Accuracy Requirement: | Achieved: Not explicitly stated as a percentage in the document, but the text states: "Success criteria were based on conformance of the cNerve detections to ground truth annotations of nerve bundles in individual frames. Since the intended use is nerve tracking during scouting rather than nerve segmentation accuracy, success criteria were derived via a preliminary survey. The target of the survey was to identify thresholds for pixel accuracy in frames and for frame accuracy in sequences that are appropriate for the intended use." |
| At least 70% of the sequences are meaningfully detected. | Achieved: Not explicitly stated as a percentage in the document. The study's focus was on meeting the success criteria derived from the preliminary survey which aimed to define "meaningfully detected" and "successfully detected" based on pixel and frame accuracy thresholds. |
| At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria). | Achieved: Not explicitly stated as a percentage in the document. The study's focus was on meeting the success criteria derived from the preliminary survey which aimed to define "meaningfully detected" and "successfully detected" based on pixel and frame accuracy thresholds. |
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.
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(96 days)
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
| Acceptance Criteria (cNerve) | Reported Device Performance (cNerve) |
|---|---|
| Success Criteria: Based on conformance of cNerve detections to ground truth annotations of nerve bundles in individual frames. These criteria were derived from a preliminary survey to identify appropriate thresholds for pixel accuracy in frames and frame accuracy in sequences, considering the intended use of nerve tracking during scouting rather than nerve segmentation. | Achievement: Implied that the device met these criteria, as the overall sequence accuracy requirement was met. The specific pixel accuracy and frame accuracy thresholds from the survey are not detailed, but the derived "cNerve performance requirements" were met. |
| Sequence Accuracy Requirement: At least 70% of the sequences are meaningfully detected. | Achievement: The study implicitly found this criterion to be met, as it states "cNerve performance requirements" were satisfied. Specific percentages are not provided in the summary. |
| Sequence Accuracy Requirement: At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria). | Achievement: The study implicitly found this criterion to be met, as it states "cNerve performance requirements" were satisfied. Specific percentages are not provided in the summary. |
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.
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(95 days)
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)
| Acceptance Criterion (cNerve) | Reported Device Performance (cNerve) |
|---|---|
| Overall cNerve Performance (Sequence Accuracy) | |
| At least 70% of the sequences are meaningfully detected. | Performance not explicitly stated as a percentage for "meaningfully detected sequences" in the provided document, but implied by the "successfully detected" metric. |
| At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria). | The document states performance requirements, but the actual achieved performance data (e.g., "cNerve achieved X% of meaningfully detected sequences" or "cNerve successfully detected Y% of these") against these specific criteria are not numerically reported in the "AI Summary of Testing" section. It only states what the performance requirements are, not what was measured against those requirements. |
| Pixel Accuracy in Frames (Specific thresholds for appropriate intended use derived from preliminary survey) | Specific numerical thresholds for pixel accuracy are not provided in the document. |
| Frame Accuracy in Sequences (Specific thresholds for appropriate intended use derived from preliminary survey) | Specific numerical thresholds for frame accuracy are not provided in the document. |
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.
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(110 days)
The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.
The Vivid T9 / Vivid T8 is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid T9 / Vivid T8 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.
The document is a 510(k) Premarket Notification Submission for the GE Vivid T8 and Vivid T9 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through new clinical studies.
Based on the provided text, there are no specific acceptance criteria or a study detailed that directly proves the device meets such criteria in terms of diagnostic accuracy or effectiveness. Instead, the submission focuses on comparing the new device to predicate devices to establish substantial equivalence.
Here's a breakdown of the information that can be extracted, particularly in relation to the questions asked, even if direct answers for "acceptance criteria" and "study proving it" are not present:
-
Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the direct sense of a new study with explicit performance metrics against acceptance criteria. The document claims "performance is substantially equivalent to the predicate device(s)" based on similar technology, intended use, imaging capabilities, and safety/effectiveness. The performance comparison is implicitly tied to the cleared performance of the predicate device. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." Therefore, no test set sample size, data provenance, or study type (retrospective/prospective) is provided for a new clinical performance study. -
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 no new clinical studies were conducted to establish performance against ground truth, this information is not available in the document. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical performance study was conducted. -
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 a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study is mentioned. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no new clinical performance study was required. The "ground truth" for substantial equivalence is based on the previously established safety and effectiveness of the predicate devices. -
The sample size for the training set:
Not applicable for a clinical training set, as no new clinical studies were conducted. The device's "training" refers to its design and evaluation based on engineering principles and comparison to existing, cleared technologies. -
How the ground truth for the training set was established:
Not applicable.
Summary of what the document focuses on instead:
The submission relies on demonstrating Substantial Equivalence to legally marketed predicate devices, primarily the Vivid T8 (K160078), Vivid E95 (K170823), Vivid iq (K161706), and Vscan Extend (K180995), along with other LOGIQ systems for specific transducer applications.
The key points for establishing substantial equivalence are:
- Intended Use: The Vivid T9 / Vivid T8 shares the same intended use as predicate devices: ultrasound imaging, measurement, and analysis of the human body for multiple clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult/Neonatal Cephalic, Musculoskeletal Superficial/Conventional, Transcranial, Transrectal, Transvaginal, Transesophageal, Intraoperative, and Tissue Biopsy).
- Technological Characteristics: The device employs the same fundamental scientific technology as its predicate devices.
- Imaging Modes: Identical imaging modes to the predicate Vivid T8 (K160078).
- Transducers: Similar transducers, with new additions (C1-5-RS and E8Cs-RS for Vivid T9) and expanded applications for existing transducers (e.g., Intraoperative for L8-18i-RS, and various clinical applications for 4C-RS, 8C-RS, 3Sc-RS, 6S-RS, 12S-RS, 9T-RS, L8-18i-RS, C1-5-RS, E8Cs-RS) that were cleared on other predicate systems.
- New Features: New features like Virtual convex, QuickApps, Cardiac AutoDoppler, Virtual Apex, Strain and Strain Rate, and Pediatric Z-score (expanded data) were cleared in predicate Vivid E95 (K170823). Tricefy Uplink was cleared with predicate Vscan Extend (K180995). Improvements were made to AFI and Auto EF, which were cleared on predicate Vivid T8 (K160078).
- Safety and Performance: The systems are manufactured with safe materials, have acoustic power levels below FDA limits, and comply with approved electrical and physical safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM). Quality assurance measures (Risk Analysis, Requirements/Design Reviews, various levels of testing) are applied.
Conclusion: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This means that the acceptance criteria are largely met by demonstrating that the device is as safe and effective as existing, legally marketed ultrasound systems, based on an engineering and feature-by-feature comparison rather than a new clinical trial with specific performance metrics.
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