Search Results

The Versana Balance is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/ Color/PWD, B/Power/PWD, B Flow/B Flow Color.

Versana Balance is intended to be used in a hospital or medical clinic.

The Versana Balance is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.

The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.

The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device.

The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) summary from the FDA for a diagnostic ultrasound system (Versana Balance). While it details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for AI features.

The document states: "The subject of this premarket submission, Versana Balance, did not require clinical studies to support substantial equivalence." This means that the device's clearance was based on its similarity to previously cleared devices, rather than a new clinical study demonstrating specific performance metrics for AI in humans.

The document mentions an "Artificial Intelligence (AI) feature that identifies key anatomies/organs", namely "Whizz Label". It also states that "Whizz Label was first cleared with Versana Premier (K210438)". This implies that any performance data or acceptance criteria for this AI feature would have been part of the K210438 submission, not K220446.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions related to the acceptance criteria and the study proving the device meets those criteria for the AI features requested. This document focuses on the substantial equivalence of the overall ultrasound system to predicate devices, rather than detailed performance metrics of its AI components.

Ask a specific question about this device

The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid and testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

DC-N2/DC-N2S is asoftware controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power , iScape, Smart 3D or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.

The provided 510(k) summary for the DC-N2/DC-N2S Diagnostic Ultrasound System states "Clinical Studies: Not applicable. The subject of this submission, DC-N2/DC-N2S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, it does not contain information regarding acceptance criteria, study design, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, or standalone performance studies.

The submission focuses on demonstrating substantial equivalence through non-clinical tests and comparison with predicate devices, rather than through clinical performance data.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small . Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ E9 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical studies against acceptance criteria.

Therefore, the document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Because no clinical studies were performed, it is not possible to extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document instead focuses on:

• Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety.
• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, and NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Final Acceptance testing (Validation).
• Intended Use: A broad range of diagnostic ultrasound evaluations for various anatomical regions and clinical applications, with specific modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and other features like 3D/4D imaging and needle guidance) listed for each supported transducer.

In summary, the provided text does not contain the information required to populate the table or answer the questions as it pertains to clinical acceptance criteria and a study demonstrating performance against those criteria. The device's clearance was based on demonstrating equivalence, not on de novo clinical performance studies with acceptance criteria.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The GE Healthcare Vivid S5/S6 Ultrasound System is a diagnostic ultrasound device intended for various clinical applications. The submission K121063 does not contain acceptance criteria or study data that proves the device meets specific performance metrics. Instead, it is a 510(k) Premarket Notification Submission asserting substantial equivalence to predicate devices. This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed device that does not require premarket approval.

Key points from the submission regarding performance:

• No new clinical studies were conducted or required. The submission explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence." (Page 2)
• The device's performance is asserted to be "substantially equivalent to the predicate device(s)." (Page 2)
• The submission outlines non-clinical tests performed to ensure safety and effectiveness, including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are general safety and performance checks, not specific clinical performance metrics.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance are not present in this 510(k) submission.

The tables provided (pages 6-26) list the "Indications for Use" for the Vivid S5/S6 system and its various transducers. These tables specify for each clinical application (e.g., Fetal/Obstetrics, Abdominal, Cardiac) and mode of operation (e.g., B-mode, PW Doppler, Color Doppler) whether that combination was:

• "P" - previously cleared by FDA
• "N" - a new indication in this submission
• "E" - added under Appendix E of the Ultrasound Guidance

These tables clarify the intended uses allowed for the device and its transducers, but they do not contain any quantitative acceptance criteria or reported device performance data. They merely state the cleared usage.

In summary, the provided document does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for the following reasons:

1. No Acceptance Criteria and Reported Performance Table: The document explicitly states that no clinical studies were required to support substantial equivalence, focusing instead on non-clinical safety and performance aspects. Therefore, there are no reported performance metrics against specific acceptance criteria.
2. No Test Set Sample Size and Data Provenance: Since no clinical studies were conducted, there are no test sets or associated provenance information.
3. No Number of Experts and Qualifications: There is no mention of experts establishing ground truth for test sets, as clinical studies were not performed.
4. No Adjudication Method: Not applicable as no clinical test set was used requiring adjudication.
5. No MRMC Comparative Effectiveness Study: No such study was performed or reported.
6. No Standalone Performance: While the device functions as an algorithm (ultrasound imaging), the submission does not present standalone performance metrics in the context of a study demonstrating its diagnostic effectiveness. It relies on the equivalence to previously cleared devices.
7. No Type of Ground Truth Used: Not applicable, as there were no clinical studies generating ground truth.
8. No Sample Size for Training Set: Since this is a hardware device modification and a substantial equivalence claim, it does not involve an AI algorithm with a training set in the conventional sense described for machine learning.
9. No Ground Truth for Training Set Establishment: Not applicable as there is no mention of a training set for an AI algorithm.

The submission focuses entirely on demonstrating the safety and effectiveness of the modified device by comparing its technical characteristics and intended uses to those of legally marketed predicate devices, along with adherence to general safety standards.

Ask a specific question about this device

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE inno product is a mobile ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with ergonomic control panel with easy user interface, optimal image quality.

The information provided describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE inno ultrasonic pulsed Doppler imaging system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy against acceptance criteria.

Therefore, many of the requested items related to clinical studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established, type of ground truth used) are not applicable in this context, as the equivalence was primarily based on non-clinical tests and a comparison of features and indications for use.

Here's the breakdown of the information that can be extracted:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context refer to demonstrating that the E-CUBE inno is substantially equivalent to its predicate device (LOGIQ i, LOGIQ e, Vivid e, specifically LOGIQ e is used for comparison in the table) in terms of indications for use, material, form factor, performance, and safety characteristics. The "reported device performance" is the comparison of these characteristics between the proposed device and the predicate.

Table of Acceptance Criteria (Substantial Equivalence Comparison) and Reported Device Performance

Overall Conclusion of Equivalency:
The submitter concludes that the E-CUBE inno is substantially equivalent to the predicate device, despite some differences in indications for use, weight, console design components (like battery), and specific operating modes/accessories. These differences are deemed not to affect the essential performance or safety and effectiveness of the device. The primary differences are attributed to "cosmetic structure and component used only."

Study that Proves the Device Meets the Acceptance Criteria:

This submission is a 510(k) for an ultrasound imaging system. For such devices, clinical studies explicitly proving performance against pre-defined acceptance criteria (like accuracy, sensitivity, specificity for a diagnostic algorithm) are often not required if substantial equivalence to a predicate device can be demonstrated through other means.

The document explicitly states:
"The subject of this premarket submission, E-CUBE inno, did not require clinical studies to support substantial equivalence."

Instead, the demonstration of substantial equivalence relies on:

1. Comparison to a Legally Marketed Predicate Device: The E-CUBE inno was compared feature-by-feature to the GE Healthcare LOGIQ e (K113690) to show that it has similar technological characteristics and indications for use.
2. Summary of Non-Clinical Tests:
   • Evaluations for biocompatibility (for patient contact materials/transducers).
   • Acoustic output.
   • Thermal, electrical, electromagnetic, and mechanical safety.
   • Conformity to applicable medical device safety standards:
     • NEMA UD2, UD3
     • AIUM Medical Ultrasound Safety
     • IEC60601-1
     • IEC60601-1-2
     • IEC60601-2-37
     • ISO 10993-1
   • Application of quality management system measures during development.

Additional Requested Information (Not Applicable or Not Provided for this type of submission):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable. No clinical test set data was provided or required for this 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable.
4. 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 basic ultrasound imaging system, not an AI-assisted diagnostic device, and no MRMC studies were conducted for this 510(k).
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable. This is a hardware/software system, and its performance is evaluated as a whole in comparison to a predicate, not as a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Applicable.
7. The sample size for the training set: Not Applicable. No training set for an AI algorithm was mentioned or relevant to this 510(k).
8. How the ground truth for the training set was established: Not Applicable.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The GE Voluson S6/S8 Ultrasound System is a general-purpose imaging and analysis system. The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.

Therefore, this document does not contain explicit acceptance criteria tables with reported device performance metrics like sensitivity or specificity, nor does it detail a clinical study designed to "prove the device meets acceptance criteria" in terms of algorithm performance for specific medical tasks. Instead, it describes non-clinical tests and affirms the device's technical equivalence and safety to its predicates.

Based on the provided text, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical study. The device is a diagnostic ultrasound system, whose performance is generally assessed through imaging quality, safety, and functionality, rather than specific diagnostic accuracy metrics, which would typically be evaluated in a clinical study if new diagnostic indications or automated analysis features were being introduced.

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

Not applicable to a clinical study demonstrating performance against acceptance criteria. The document explicitly states: "The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 1)

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

Not applicable. No clinical study data for ground truth establishment is presented.

4. Adjudication Method for the Test Set:

Not applicable. No clinical study data for ground truth establishment is presented.

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

Not applicable. This device is a general diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

Not applicable. The device is a diagnostic ultrasound system that requires a human operator for image acquisition and interpretation. It is not an algorithm-only device.

7. The Type of Ground Truth Used:

Not applicable, as no dedicated clinical study assessing diagnostic performance against a ground truth is described. The "ground truth" for this type of submission relies on the established safety and performance of its predicate devices and compliance with regulatory standards.

8. The Sample Size for the Training Set:

Not applicable. As this device is not an AI/algorithm-based diagnostic product with a training set in the conventional sense, no training data or sample size is relevant for this submission.

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

Not applicable. See point 8.

Summary of Device Evaluation (from the provided text):

The GE Voluson S6, Voluson S8 Ultrasound System underwent non-clinical tests to demonstrate substantial equivalence to its predicate devices, covering:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

The development process also included standard quality assurance measures such as:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final Acceptance Testing (Validation)
• Performance testing (Verification)
• Safety testing (Verification)

The conclusion states that GE Healthcare considers the Voluson S6, Voluson S8 to be as safe, as effective, and its performance substantially equivalent to the predicate device(s). The FDA concurred with this finding of substantial equivalence based on the provided information, without requiring clinical studies.

The tables in pages 6-19 list the various clinical applications and modes of operation for the Voluson S6/S8 system with different transducers. "P" indicates applications and modes previously cleared by FDA, while "N" indicates new indications. These tables specify the intended uses and capabilities of the device and its transducers, rather than presenting acceptance criteria for a performance study.

Ask a specific question about this device