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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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS E-CUBE 7:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). This means the acceptance criteria are implicitly that the E-CUBE 7 perform comparably to the predicate device in aspects of safety and effectiveness for its intended uses.

The "reported device performance" is also not given in quantitative metrics. The document only asserts that "Performance, technology and software are substantially equivalent to the predicate device." and that "Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy."

Therefore, I cannot populate a table with numerical acceptance criteria and reported performance based on the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, E-CUBE 7, did not require clinical studies to support substantial equivalence."

This indicates that there was no test set of clinical data used to evaluate the device's performance against specific metrics. The assessment relied on non-clinical tests and a comparison to the predicate device's existing clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical studies were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was conducted. The E-CUBE 7 is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations to human readers. Therefore, the concept of readers improving with vs. without AI assistance is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was performed, as the device is an ultrasound imaging system operated by a physician, not a standalone AI algorithm.

7. The Type of Ground Truth Used

Given that no clinical studies were performed, there was no specific ground truth established for the E-CUBE 7's performance in a clinical context. The basis for clearance is substantial equivalence to the predicate device, K120060, which would have established its own safety and effectiveness through prior regulatory processes.

8. The Sample Size for the Training Set

Since no clinical studies involving machine learning or AI models were conducted, there was no training set batch of data mentioned or used.

9. How the Ground Truth for the Training Set Was Established

As there was no training set, this question is not applicable.

Summary of Findings:

The 510(k) submission for the ALPINION MEDICAL SYSTEMS E-CUBE 7 (K132687) did not involve clinical studies or performance evaluations against specific acceptance criteria for a new clinical dataset. Instead, the clearance was based on:

• Substantial Equivalence: The device was determined to be substantially equivalent to a legally marketed predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System).
• Non-Clinical Tests: Evaluation of biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, confirming conformity to applicable medical device safety standards.
• Quality Management System: Adherence to established quality management system measures (Risk Management, Requirements Reviews, Design Reviews, Component Verification, System Verification, Performance Testing, Safety Testing, Design Validation).

The document explicitly states that "E-CUBE 7... did not require clinical studies to support substantial equivalence." Therefore, details regarding clinical acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth for new clinical data are not present in this submission.

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