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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 intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; 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; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The GE 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 autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.

The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.

Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.

Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.

The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.

Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.

Missing Information (as per the document):

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
3. 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): Not applicable. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
8. The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

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