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510(k) Data Aggregation
(87 days)
The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
Venue, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and Venue Fit 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 pediatric), 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.
The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint 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 pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.
Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.
The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.
The systems have 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 is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.
The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.
The Venue, Venue Go, Venue Fit and Venue Sprint systems 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. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.
The Venue, Venue Go and Venue Fit systems are 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. Compatible biopsy kits can be used for needle-guidance procedures.
The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least 90% success rate in automatic caliper placement for bladder volume measurements when bladder wall is entirely visualized. | Automatic caliper placement success rate: 95.09% (with a 95% confidence level) |
| Performance demonstrated consistent across key subgroups including subjects with known BMI (healthy weight, obese, overweight). | Healthy weight (18.5-24.9): 95.64% |
| Obese (25-29.9): 95.59% | |
| Overweight (Over 30): 92.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
- Data Provenance:
- Country of Origin: USA and Israel.
- Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
- Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.
7. Type of Ground Truth Used (for ABV Test Set)
- Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.
8. Sample Size for the Training Set (for ABV)
- Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.
9. How the Ground Truth for the Training Set Was Established (for ABV)
- Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.
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(86 days)
Vivid Pioneer 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 or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid Pioneer 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), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).
Modes of operation include: 3D, Real time (RT) 3D Mode (4D), 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.
The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.
Vivid Pioneer 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. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.
The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.
The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.
The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all 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.
This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.
1. Table of Acceptance Criteria and Reported Device Performance
AI Cardiac Auto Doppler
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Feasibility score of > 95% | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed the check for mean percent absolute error across all cardiac cycles against a threshold. This implies the accuracy threshold was met, which indirectly suggests successful feasibility to achieve this accuracy. |
| Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Mean percent absolute error across all cardiac cycles against a threshold. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Consistent model performance across BMI groups ( |
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(63 days)
The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances.
I am sorry, but the provided text does not contain the specific information required to answer your request. The document describes a medical device (NUVISION™ NAV Ultrasound Catheter) and its substantial equivalence to predicate devices for FDA clearance. However, it does not include details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML development and validation.
The document primarily focuses on:
- Indications for Use
- Device Description
- Comparison to predicate devices (physical characteristics, intended use, technical specifications)
- General performance testing categories (bench, biocompatibility, animal testing)
Therefore, I cannot generate the requested table and information as it is not present in the provided text.
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