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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.

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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S6 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

This is a 510(k) premarket notification for the SonoScape S6 Diagnostic Ultrasound System. The document focuses on establishing substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving device performance against specific clinical endpoints. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for diagnostic tasks. Instead, it relies on demonstrating substantial equivalence to a predicate device by conforming to recognized safety and performance standards.

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

• Sample Size: Not applicable. The submission describes laboratory testing for engineering characteristics and adherence to standards, not a clinical trial with a "test set" of patients or data in the context of AI performance. The term "test set" as typically used for AI device evaluation is not relevant here.
• Data Provenance: Not applicable. The testing described is primarily laboratory-based (acoustic output, electrical safety, biocompatibility) rather than on patient data.

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

• Number of Experts: Not applicable. Ground truth, in the context of clinical diagnostic accuracy, is not discussed as this is a 510(k) for an ultrasound system, not an AI diagnostic algorithm. The evaluation focuses on engineering performance and safety.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a 510(k) for a diagnostic ultrasound system itself, not an AI algorithm intended to assist human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. The device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. There is no "algorithm only" performance reported in the context of AI.

7. The Type of Ground Truth Used

• Not applicable in the context of clinical diagnostic ground truth. The "truth" for the described testing relies on physical measurements against engineering specifications and adherence to established medical device safety and performance standards (e.g., acoustic output values, electrical impedance, biological reactivity in in-vitro tests).

8. The Sample Size for the Training Set

• Not applicable. The document describes a traditional medical device (an ultrasound machine), not an AI/Machine Learning model that would require a "training set."

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

• Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is not relevant to this submission.

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