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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal - OB/GYN
Laparoscopic
Intraoperative (abdominal organs and vascular)
Abdominal
Small Organ (breast, thyroid, testicle)
Trans-vaginal
Trans-rectal
Musculo-skeletal (conventional)
Musculo-skeletal (superficial)
Neonatal Cephalic
Pediatric
Cardiac-(adult and pediatric)
Trans-esophageal (non-cardiac)
Peripheral Vessel
Other

1. Gastrointestinal tract and the surrounding Organs
2. The airways and tracheobronchial tree

The EU-C60 is a general purpose, compact, software-controlled, diagnostic ultrasound system. The EU-C60 has compatibility with SonoSite transducers (such as abdominal or intracavital transducers) and Olympus Ultrasound videoscope. Its function is to acquire ultrasound data and display it on a monitor in several modes. ( 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.) The EU-C60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. The GF-UC160P-OL5/GF-UCT160-OL5 give the operator the ability to perform Endocopic Ultrasound(EUS) guided fine needle aspiration(FNA).

The provided text is a 510(k) Premarket Notification from the FDA for the Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center. This document's primary purpose is to demonstrate substantial equivalence to previously marketed devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner that a clinical trial for a novel AI algorithm would.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this type of regulatory submission. The document focuses on demonstrating that the new device performs within the expected parameters of existing, legally marketed ultrasound systems.

Here's an analysis of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) as would be found in a performance study for an AI device. Instead, the "performance" is implicitly demonstrated by stating that the device "operates identically to the predicate devices" and "complies with the standards listed below."

2. Sample size used for the test set and the data provenance:

• Not provided. This document is not a clinical study report with a test set of patient data. The "study" here refers to the process of demonstrating substantial equivalence, which primarily involves comparing the device's technical specifications and intended uses to those of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of an external test set with ground truth established by experts.

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

• Not applicable. No test set or adjudication process is described.

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 conducted/applicable. This is not an AI device, and no MRMC study is mentioned.

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

• Not conducted/applicable. This is a diagnostic ultrasound system, not an algorithm, and the concept of "standalone performance" in the AI sense does not apply.

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

• Not applicable. The "ground truth" in this context is the performance and safety profiles of the predicate devices and compliance with established medical device standards.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. See above.

In summary:

This document is a regulatory submission demonstrating substantial equivalence for a physical medical device (an ultrasound system). It leverages comparison to existing, legally marketed predicate devices and compliance with relevant safety and performance standards. It does not contain information about clinical performance studies with specific acceptance criteria, test sets, or ground truths as would be expected for an AI-based diagnostic tool.

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