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The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 11 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

The provided text describes the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 11 ultrasound system, a Class II medical device, and its substantial equivalence to predicate devices, focusing on technical characteristics and safety standards rather than human performance studies or detailed acceptance criteria with reported device performance.

Therefore, the following information cannot be fully extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document states: "The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence." This indicates that no new clinical efficacy studies evaluating device performance against acceptance criteria were conducted or presented in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices by comparing technical specifications, imaging modes, and adherence to safety standards.

However, I can provide the acceptance criteria in terms of the standards and features the device conforms to, as reported in the "Summary of Non-Clinical Tests" and "Determination of Substantial Equivalence" sections.

1. Table of Acceptance Criteria (as per conformance to standards and features) and the Reported Device Performance (as stated in the summary of non-clinical tests and comparison to predicates):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence." Therefore, no specific test set sample size or data provenance from clinical studies is provided. The evaluation was based on non-clinical tests ensuring safety and performance compliance with standards and comparison to predicate devices' technical specifications.

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, as no clinical studies with expert-established ground truth were conducted for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were conducted for this submission.

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. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as the device is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with ground truth establishment were conducted for this submission.

8. The sample size for the training set
Not applicable, as the device is a diagnostic ultrasound system and no specific training set for an AI model is mentioned or relevant to this 510(k) submission.

9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is mentioned or relevant to this 510(k) submission.

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