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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, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).

E-CUBE 8 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 document is a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily addresses equivalence and adherence to standards for safety and performance, rather than specific acceptance criteria and study designs typically found for novel devices or AI/ML-driven diagnostics.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) or independent reported device performance metrics in the way one would for an AI/ML diagnostic or a more novel technology. Instead, it demonstrates performance by:

• Claiming Substantial Equivalence: The primary "performance" metric is that the E-CUBE 8 is "as safe, as effective" and its "Performance, technology and software are substantially equivalent" to several predicate ultrasound devices (e.g., K172732, K161439, K153424, K132687, K163691, K163120).
• Listing Supported Indications and Imaging Modes: The device supports a wide range of clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), Peripheral Vascular, Urology) and various imaging modes (2D(B), Harmonic, M, Color M, Anatomical M, Color Flow Doppler (CF), Power Doppler (PD), Directional PD, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), High PRF Doppler, Tissue Doppler Imaging (TDI), 3D/4D). The presence of these modes and applications, matching those of predicate devices, implicitly serves as a performance metric of functional equivalence.
• Compliance with Voluntary Standards: Adherence to standards like IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, AIUM Medical Ultrasound Safety, NEMA UD 2, and NEMA UD 3 indicates that the device meets established safety and basic performance criteria common to ultrasound systems.

Acceptance Criteria (Implicitly based on predicate device equivalence and standards compliance):

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

The document states: "The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used in a clinical study to evaluate the device against acceptance criteria in the typical sense for a new diagnostic claim. Instead, the evaluation was primarily based on engineering tests, compliance with standards, and comparison of technical specifications to predicate devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable here.

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

As no clinical studies were required, there was no "test set" in the context of diagnostic performance involving ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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 system, not an AI-driven image analysis tool intended to assist human readers for diagnostic interpretation in the manner described. The document does not mention any AI components in K181617.

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

Not applicable. The E-CUBE 8 is an ultrasound imaging system, an equipment device, not a standalone AI algorithm. The document makes no mention of AI/ML functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with "ground truth" for diagnostic performance were conducted. The "ground truth" in this context refers to the established safety and performance characteristics of legally marketed predicate ultrasound devices and the voluntary standards for ultrasound equipment.

8. The sample size for the training set

Not applicable. This device is an ultrasound system hardware/software combination, not an AI/ML product developed with a training dataset.

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

Not applicable, as no AI/ML training set was involved.

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