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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 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The 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 documentation does not contain detailed acceptance criteria for specific performance metrics of the E-CUBE 9 ultrasound system in a clinical context. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K060993 LOGIQ P5/A5 Diagnostic Ultrasound System) through non-clinical tests and a declaration that clinical studies were not required.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical performance cannot be extracted from this document.

The document mainly highlights:

• Non-Clinical Tests: Evaluation for biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards.
• Voluntary Standards Compliance: The device's application complies with voluntary standards as detailed in the premarket submission.
• Quality Management System Measures: Mention of Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation.

The key statement regarding clinical data is:

"The subject of this premarket submission, E-CUBE 9, did not require clinical studies to support substantial equivalence."

This indicates that the FDA granted clearance based on non-clinical data and the device's technical similarity to a previously cleared device, rather than requiring new clinical performance studies with specific acceptance criteria that would typically be evaluated in such studies.

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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); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with the 17" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality

The Alpinion E-CUBE 9 is an ultrasonic pulsed Doppler imaging system.

Acceptance Criteria and Device Performance:

The E-CUBE 9 utilizes the same fundamental scientific technology as its predicate device, the LOGIQ P5/A5 Diagnostic Ultrasound System (K060993). Therefore, its "acceptance criteria" are based on demonstrating substantial equivalence to this predicate device in terms of safety, effectiveness, and performance. The primary method for proving this substantial equivalence, in this case, involves non-clinical testing and comparison of intended uses.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

This 510(k) summary explicitly states: "The subject of this premarket submission, E-CUBE 9, did not require clinical studies to support substantial equivalence."

Therefore, the following information regarding clinical studies or test sets is not applicable to this submission:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical studies were performed.
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 were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical studies were performed.
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 is a diagnostic ultrasound imaging system, and the submission does not involve AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a diagnostic ultrasound imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical studies were performed. The "ground truth" for substantial equivalence was based on meeting engineering and safety standards and having equivalent intended uses to a predicate device.
8. The sample size for the training set: Not applicable as no clinical studies or AI/machine learning development requiring a "training set" were described.
9. How the ground truth for the training set was established: Not applicable as no clinical studies or AI/machine learning development requiring a "training set" were described.

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