Search Results
Found 6 results
510(k) Data Aggregation
(102 days)
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system 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. 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. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vscan Air, outlining its substantial equivalence to predicate devices. It does not contain information on specific acceptance criteria and the detailed study results that prove the device meets these criteria in terms of clinical performance (e.g., accuracy, sensitivity, specificity) for a particular AI function.
The document primarily focuses on:
- Regulatory information: Device name, regulation, product codes, predicate devices.
- Intended Use/Indications for Use: Describes the general applications of the ultrasound system.
- Technological comparison: Explains how the Vscan Air is similar to its predicate and reference devices in terms of technology, modes, transducers, and software features.
- Non-Clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning/disinfection, and electrical/electromagnetic/mechanical safety, and adherence to various safety standards.
- Absence of Clinical Studies: Explicitly states, "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."
Therefore, based on the provided input, I cannot fulfill the request for:
- A table of acceptance criteria and reported device performance (for clinical/AI performance).
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document confirms that this particular submission for Vscan Air did not require clinical studies, implying that the performance evaluation relied on non-clinical testing and comparison to predicate devices, rather than a prospective clinical trial with a defined test set and established ground truth for an AI algorithm.
Ask a specific question about this device
(70 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 clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), VascularPeripheral 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, 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 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 analysis. 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. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.
The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
Venue Fit is capable of wired or wireless internet connection and a barcode reader is available to be used as an input device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory available for the customer is a roller bag.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification submission for a medical device (Venue Fit ultrasound system).
It primarily focuses on:
- Regulatory information: FDA letter, indications for use, and a 510(k) summary.
- Device description: Explaining the Venue Fit's features, intended use, and technical specifications.
- Comparison to predicate devices: Highlighting similarities and differences with previously cleared GE ultrasound systems.
- Non-clinical tests: Listing the safety and performance standards the device complies with (e.g., acoustic output, biocompatibility, electrical safety).
- A statement explicitly saying: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence."
Therefore, there is no information regarding:
- Acceptance criteria for AI/algorithm performance.
- Results of a study proving the device meets acceptance criteria (as no clinical studies were required).
- Sample sizes for test or training sets.
- Data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for training was established.
This document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, rather than a clinical study involving AI performance metrics.
Ask a specific question about this device
(103 days)
The Venue Go 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 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), VascularPeripheral 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, 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 and trained 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 variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.
The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
The provided text describes the GE Medical Systems Ultrasound and Primary Care Diagnostics' Venue Go device and its 510(k) premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, the document details the device's technical specifications, intended use, comparison to predicate devices, and compliance with non-clinical safety standards (acoustic output, biocompatibility, electrical safety, etc.). The "Summary of Non-Clinical Tests" section outlines various standards the device complies with, but these are safety and engineering standards, not performance criteria for a diagnostic algorithm.
Specifically, the "Summary of Clinical Tests" section explicitly states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This means that no clinical performance study was conducted to establish diagnostic accuracy metrics for the device itself. The substantial equivalence argument is based on its similarity to existing, legally marketed ultrasound systems.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as it is not present in the provided text.
If you have a document that describes the diagnostic performance claims and supporting studies for the Venue Go or a similar medical device, please provide that text, and I will be able to answer your questions.
Ask a specific question about this device
(105 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), VascularPeripheral 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, 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 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 proposed Venue has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.
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 and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.
The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not contain specific acceptance criteria or quantitative performance metrics for the device itself. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing:
- Clinical Indications for Use: Similar, with some additions cleared on reference devices.
- Technological Characteristics: Same fundamental scientific technology.
- Safety and Effectiveness: Assessed through non-clinical tests.
- Imaging Modes and Transducers: Largely identical or similar, with additions cleared on reference devices.
- Features/Functionality: Modifications or additions that are similar to features already cleared on predicate or reference devices.
Therefore, a table of acceptance criteria and reported device performance, as typically understood for AI/ML device performance, cannot be constructed from this document. The "performance" being demonstrated here is the device's adherence to safety standards and its functional equivalence to existing cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."
Therefore, there was no test set as part of a clinical study for this 510(k) submission, and consequently, no sample size or data provenance information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.
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
The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."
Therefore, no MRMC study was performed, and this information is not applicable and not provided in the document. The device descriptions focus on general ultrasound functionalities without specific mention of AI-assisted diagnostic features that would warrant such a study. While some "automated tools" are mentioned, their performance is established through similarity to pre-cleared features, not through comparative effectiveness studies in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."
Therefore, no standalone performance study was done for this submission, and this information is not applicable and not provided in the document.
7. The Type of Ground Truth Used
As no clinical study was required and no test set was used, this information is not applicable and not provided in the document. The substantial equivalence argument relies on comparison to predicate and reference devices, not on direct ground truth validation in a clinical setting for this specific submission.
8. The Sample Size for the Training Set
The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."
Since no clinical studies were performed, and the submission does not describe the development or training of new AI/ML algorithms requiring a training set, this information is not applicable and not provided in the document. The "automated tools" mentioned are described as modifications or similar to features already cleared on other devices.
9. How the Ground Truth for the Training Set Was Established
As no training set was used for a clinical study in this submission, this information is not applicable and not provided in the document.
Ask a specific question about this device
(145 days)
L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.
The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain and to evaluate the Right Ventricle and well as to measure the bladder.
This document describes the acceptance criteria and study results for DiA Imaging Analysis Ltd's LVivo Software Application, specifically focusing on its LVivoRV (Right Ventricular) and LVivo Bladder modules.
1. Table of Acceptance Criteria and Reported Device Performance
| Module | Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| LVivoRV | FAC Correlation | 75% correlation (r ≥ 0.75) between LVivoRV's FAC measurement and manual FAC measurements by sonographers. This value is based on statistical data reported by FDA cleared systems for semi-automated RV function evaluation (e.g., EchoInsight by Epsilon). | Primary Endpoint Met: Excellent correlation (r=0.79, p |
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 1