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The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular).

The K3900 Ultrasound Imaging System ("K3900") is a Track 3 general purpose ultrasound imaging system. The device generates and collects ultrasonic pulsed echo data via a transducer that is then digitized for further processing. The processing includes beamforming, image processing, and image optimization that then outputs an ultrasound image. This image may be displayed on a tablet or common displays through HDMI for general purpose radiological evaluation. The K3900 consists of an ultrasound transducer, a processing unit that manages the transducer and all data processing, and a tablet that provides the user interface to operate the device, view and analyze the ultrasound dataset, and manage patient study sessions.

The provided text is a 510(k) Summary for the MAUI Imaging K3900 Ultrasound Imaging System. It includes information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not contain specific acceptance criteria, reported device performance metrics in a tabular format, information about sample size for test sets (beyond "numerous anatomical structures"), expert qualifications, adjudication methods, details of MRMC studies, or specific sample sizes for training sets.

Here's a breakdown of what can be extracted and what is missing from the provided document regarding your request:

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

• Acceptance Criteria (Implicit): The document implies that the acceptance criteria are met if the K3900 Ultrasound Imaging System demonstrates "substantial equivalence" to the predicate device (GE LOGIQ E9 K152309) and "does not raise different questions of safety or effectiveness." This is a qualitative statement, not quantitative criteria.
• Reported Device Performance: The document only states that "Side-by-side comparisons of the still images of numerous anatomical structures showed that the imaging from the subject device was substantially equivalent to the predicate." No specific metrics (e.g., sensitivity, specificity, image quality scores, quantitative measurements) are provided.

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

• Sample Size for Test Set: Not explicitly stated beyond "volunteers were recruited" and "numerous anatomical structures."
• Data Provenance: Prospective, collected in a radiology clinic. The country of origin is not specified but implied to be the US given the FDA submission.

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

• Number of Experts: One expert is explicitly mentioned: "a radiologist captured ultrasound images from both devices."
• Qualifications of Experts: Only "a radiologist" is mentioned. No details about experience level or subspecialty are provided.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The comparison was described as "Side-by-side comparisons of the still images." It's unclear if there was any formal adjudication process beyond the single radiologist's assessment.

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

• MRMC Comparative Effectiveness Study: No, this was not an MRMC study and it does not involve AI assistance. The study was a comparison of two ultrasound imaging systems.

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

• This question is not applicable as the K3900 is an ultrasound imaging system, not an AI algorithm. Its performance is inherent in the image it produces for human interpretation, not as a standalone diagnostic algorithm. The comparison was about the quality of the images produced by the system.

7. The type of ground truth used

• Type of Ground Truth: The ground truth was established by "comparative ultrasound imaging data" assessed by "a radiologist." This implies a visual assessment/expert comparison rather than pathology or long-term outcomes. The predicate device (GE LOGIQ E9) serves as the reference standard for what is considered "equivalent imaging."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The document describes an ultrasound imaging system, not an AI/machine learning model that typically has a "training set."

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

• How Ground Truth for Training Set was Established: Not applicable (see point 8).

In summary, while the document confirms that a clinical performance study was conducted to demonstrate substantial equivalence, it lacks the specific quantitative details regarding acceptance criteria, performance metrics, and detailed study design (like sample sizes and expert qualifications) that your questions ask for.

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