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510(k) Data Aggregation
(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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(77 days)
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode
The V8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8 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 V8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) Summary for the Samsung Medison V8 Diagnostic Ultrasound System. It details the device's intended use, technological comparison to predicate devices, and non-clinical testing. However, it explicitly states that no clinical studies were required to demonstrate substantial equivalence.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, rather than a clinical study with defined performance metrics and acceptance criteria.
The relevant section from the document is:
12. Summary of Clinical Tests
The proposed device V8 Ultrasound System did not require clinical studies to demonstrate substantial equivalence.
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