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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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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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (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.

Here's an analysis of the acceptance criteria and study information for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification from the FDA for a medical ultrasound system. It primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device might. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with ground truth, and training set details) are not applicable or not provided in this type of regulatory document for a general ultrasound system. The "studies" mentioned are largely non-clinical engineering and safety compliance tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the E-CUBE 8 are primarily related to its equivalency with predicate devices regarding Indications for Use, Imaging Modes, Imaging Functions, and adherence to established safety and performance standards. The reported device performance is that it meets these criteria by incorporating similar or improved features and by complying with relevant medical device standards.

Study Information

1. Sample size used for the test set and the data provenance:

   • N/A. The document does not describe a "test set" in the context of a dataset used for performance evaluation (e.g., for an AI/ML algorithm). The "testing" involved non-clinical validation against engineering specifications and industry standards.
   • Data Provenance: Not applicable in the context of device performance testing. The provenance of regulatory compliance data is the manufacturing and testing environment of ALPINION Medical Systems Co., Ltd., based in the Republic of Korea.

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

   • N/A. This information is not relevant or provided for a general ultrasound system's 510(k) submission. "Ground truth" in this context would primarily relate to the accuracy of physical measurements and image quality, which are assessed through engineering tests rather than expert interpretation of a diagnostic dataset.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. No adjudication method for a test set is mentioned, as there isn't a diagnostic performance study described that would require it.

4. 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:

   • No. An MRMC comparative effectiveness study was not performed or referenced. This document is for a traditional ultrasound imaging system, not an AI-assisted diagnostic device.

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

   • No. This device is a diagnostic ultrasound system intended for use by a qualified physician. Its performance is inherent to the imaging capabilities and is not evaluated as a standalone algorithm without human intervention.

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

   • N/A. For this type of submission, "ground truth" refers to the established engineering specifications, physical laws, and recognized standards against which the device's technical performance (e.g., acoustic output, image resolution, measurement accuracy) is validated. It does not involve medical ground truth from patient data like pathology or outcomes.

7. The sample size for the training set:

   • N/A. This device does not use a "training set" in the context of machine learning. Its functionality is based on established ultrasound physics and engineering design.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this device.

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