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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular. Applicable combined modes: B+M+PW+CW+CFM+PD. New indication: Tissue Harmonic Imaging for Cardiac.

ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption. The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.

This submission, K994369, appears to be for a 7250 Ultrasound Imaging System with the addition of a new imaging mode: Tissue Enhancement Imaging (TEI) or 2nd Harmonic Imaging Mode. The provided text is a 510(k) summary, formal FDA correspondence, and Indications for Use forms.

It is important to note that the provided document does NOT contain a study or data proving the device meets specific acceptance criteria related to its diagnostic performance (e.g., sensitivity, specificity, accuracy) for the new Tissue Enhancement Imaging mode. Instead, this document focuses on demonstrating substantial equivalence to a predicate device, primarily through technical and safety comparisons, and specifying the intended uses for the added mode.

Therefore, many of the requested sections about specific performance criteria, study design, sample sizes, and ground truth establishment cannot be extracted directly from the provided text. The submission relies on the established safety and efficacy of the predicate device and the general understanding of ultrasound technology, along with safety testing for the new mode.

Here's an attempt to answer the questions based on the available information, noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K994369 summary, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, image quality metrics) or corresponding reported performance data for the new Tissue Enhancement Imaging mode from a diagnostic study.

The acceptance criteria implicitly referred to in this 510(k) revolve around substantial equivalence to the predicate device (Esaote 7250, K982444), particularly in terms of:

• Safety: Meeting electrical (EN60601-1) and ultrasound safety standards (Track 3 Acoustic Output Display).
• Technical Specifications: Matching or being comparable to the predicate for imaging frequencies, CFM/Doppler frequencies, biopsy guidance features, display type, digital archival capabilities, and measurement capabilities.
• Intended Use: The new mode expanding the indications for use for Cardiac applications.

While no explicit performance table is available, here's how the general comparison is presented:

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

Not specified in the provided document.

The document details a 510(k) submission for adding a new imaging mode (Tissue Enhancement Imaging) to an existing ultrasound system. It does not describe a clinical performance study with a "test set" in the sense of patient data used to evaluate diagnostic accuracy. The evaluation is focused on technical and safety equivalence to the predicate device.

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.

No ground truth establishment by experts is described, as no clinical performance study for diagnostic accuracy is detailed in this 510(k) summary.

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

Not applicable.

No clinical performance study requiring adjudication is detailed.

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.

This is an ultrasound imaging device, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable.

This is an ultrasound imaging device, not an algorithm, and no standalone performance study is detailed.

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

Not applicable.

No clinical performance study requiring a ground truth is detailed. The submission is focused on demonstrating the safety and technical comparability of the new imaging mode to the predicate device and general ultrasound standards.

8. The sample size for the training set

Not applicable.

This submission does not describe an AI or machine learning model that would require a training set.

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

Not applicable.

This submission does not describe an AI or machine learning model that would require a training set with established ground truth.

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