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

E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 21.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

This document is a 510(k) Premarket Notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 12 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device, the E-CUBE 15 Diagnostic Ultrasound System (K123610), rather than outlining specific acceptance criteria and detailed study results for a new device's performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and the type of ground truth used as part of a comparative effectiveness study or standalone performance evaluation is not explicitly provided in the given text.

The document states: "The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence." This means that rigorous clinical performance studies with acceptance criteria and detailed statistical analysis, as typically expected for proving device performance, were not conducted or submitted for this specific 510(k) approval. Instead, the approval is based on comparing the new device to a legally marketed predicate.

However, I can extract and infer some information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence): The E-CUBE 12 must perform as safely and effectively as the predicate device (E-CUBE 15 K123610) for its intended uses. This is primarily demonstrated by showing conformity to applicable safety standards and similar technological characteristics.

Missing Information Details:

2. Sample sizes used for the test set and the data provenance: Not provided. The submission states no clinical studies were required for substantial equivalence, implying no dedicated "test set" in the context of clinical performance evaluation studies was used. The focus was on non-clinical testing to verify design changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies with expert ground truth establishment for a test set were conducted.
4. Adjudication method for the test set: Not applicable, as no clinical studies with a test set requiring adjudication were conducted.
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. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool for interpretation, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging device, not an algorithm being evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance studies requiring ground truth were conducted. The "ground truth" here is conformity to safety standards and equivalence to an already approved device.
8. The sample size for the training set: Not applicable, as no machine learning algorithm development requiring a "training set" is described for this premarket notification.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of the "Study" (Non-Clinical Evaluation):

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence is a non-clinical evaluation rather than a traditional clinical trial.

• Non-Clinical Tests: ALPINION MEDICAL SYSTEMS Co., Ltd. conducted evaluations for:
  • Biocompatibility of transducer materials and patient contact materials.
  • Acoustic output.
  • Thermal, electrical, electromagnetic, and mechanical safety.
• Standards Conformance: The device was found to conform to applicable medical device safety standards, specifically:
  • NEMA UD2, UD3
  • AIUM Medical Ultrasound Safety
  • IEC60601-1
  • IEC60601-1-2
  • IEC60601-2-37
• Quality Management System Measures: The development process followed these measures:
  • Medical Device Risk Management
  • Requirements Reviews
  • Design Reviews
  • Component Verification
  • Integration Review (System Verification)
  • Performance Testing (System Verification)
  • Safety Testing (Compliance Test)
  • Design Validation
• Basis for Equivalence: The manufacturer concluded that the E-CUBE 12 is "as safe, as effective" as the predicate device (E-CUBE 15, K123610) because it employs the same fundamental scientific technology, and any differences in clinical applications or operating modes were verified through these non-clinical tests to not affect safety, effectiveness, and essential performance.

In essence, the "study" for this 510(k) was a comprehensive set of engineering and safety tests and a review of the design and manufacturing process, all aimed at demonstrating that the device is equivalent to a previously cleared device.

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