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The Vivid T8 is a multipurpose cardiovascular ultrasound system intended for diagnostic ultrasound imaging and fluid flow analysis. The system supports the following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular. Adult Cephalic. Neonatal Cephalic. Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.

The Vivid T8 is the full featured cardiovascular diagnostic ultrasound system designed for cardiac and shared service imaging which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel

This is a premarket notification for the GE Vivid T8 ultrasound system. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of the information that is present in relation to your request, and what is not:

1. A table of acceptance criteria and the reported device performance

• This document does not contain a table of acceptance criteria for diagnostic performance or specific device performance metrics in relation to clinical efficacy.
• The tables provided (pages 5-16) describe "Indications for Use" for different transducers with various clinical applications and modes of operation. These tables indicate whether an indication is "new" (N) or "previously cleared" (P, P1, P2) with predicate devices. This represents the scope of intended use rather than performance criteria.
• The "Summary of Non-Clinical Tests" (page 19-20) lists compliance with various medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, ISO14971, NEMA DICOM). These are safety and engineering standards, not diagnostic performance acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document explicitly states on page 20, "The subject of this premarket submission, Vivid T8, did not require clinical studies to support substantial equivalence."
• Therefore, there is no information on a test set, sample size, or data provenance related to clinical diagnostic performance.

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)

• As clinical studies were not required, there is no information on experts, ground truth establishment, or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• As clinical studies were not required, there is no information on an adjudication method.

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

• No clinical studies were performed. The document mentions "Scan Coach feature" and "Smart Start feature with battery" as additions, stating they are "equivalent to that cleared in the LOGIQ F Series (K133034)" and "equivalent to that cleared in Vivid S5/S6 (K121063)" respectively (page 18). These are features, possibly with AI components, but no MRMC study or effect size of AI assistance is discussed or presented.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No clinical studies or standalone algorithm performance evaluations are discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• No ground truth for diagnostic performance is discussed as clinical studies were not performed.

8. The sample size for the training set

• No information about a training set for an AI/algorithm is provided.

9. How the ground truth for the training set was established

• No information about ground truth establishment for a training set is provided.

In summary, this FDA 510(k) clearance document for the GE Vivid T8 ultrasound system does not contain the detailed information requested regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, imaging capabilities, technological characteristics, and compliance with safety standards, without requiring new clinical performance studies.

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