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

E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging (THI)
2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
   Acoustic output track: Track 3

The provided text describes the "E-CUBE 15 Diagnostic Ultrasound System" and its various transducers but does not contain information about specific acceptance criteria, studies proving performance, sample sizes, data provenance, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to any AI components. The document is a 510(k) premarket notification to the FDA, focusing on establishing substantial equivalence to previously cleared predicate devices for various clinical applications and operating modes.

The document lists the intended uses and technical specifications of the E-CUBE 15 system and its transducers, comparing it to predicate devices (E-CUBE 9 and iU22). The "Summary of Non-Clinical Tests" mentions evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. It also lists quality management system measures applied during development.

Crucially, the "Summary of Clinical Tests" section explicitly states:
"The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

This means that for the purposes of this 510(k) submission, the device's substantial equivalence was established through non-clinical testing and comparison to predicate devices, rather than through clinical trials with defined acceptance criteria for AI performance, independent test sets, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance for AI components cannot be extracted from this document, as it appears the submission did not rely on such data for device clearance. The document focuses on hardware aspects and basic functional modes, not advanced AI features requiring such rigorous evaluation.

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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 15 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.

The provided document is a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 15 ultrasonic imaging system. It primarily details the device's substantial equivalence to a predicate device and its compliance with safety and performance standards.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity) for the E-CUBE 15's imaging performance. Instead, the "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections indicate the following as the basis for device performance and safety:

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

The document explicitly states: "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

Therefore, there is:

• No test set sample size reported as no clinical studies were performed.
• No data provenance (country of origin, retrospective/prospective) because no clinical data was collected for this submission.

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

Since no clinical studies were conducted for the E-CUBE 15 to establish performance against a test set, there is no information provided regarding:

• The number of experts.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

As no clinical studies were conducted involving expert interpretation of a test set, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

The document states that "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence." Therefore, no MRMC comparative effectiveness study was done, and thus no effect size of human readers improving with AI vs. without AI assistance is reported. (Note: AI is not explicitly mentioned as a component of this device, which is an ultrasonic imaging system.)

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

This device is an ultrasonic imaging system. The submission focuses on its hardware and software for image acquisition and display, and its equivalence to a predicate device. It is not an AI/algorithm-only device, so a standalone algorithm performance study is not applicable and not reported. The "performance" assessment is based on compliance with safety standards and fundamental scientific equivalence to the predicate device.

7. The Type of Ground Truth Used

Given that no clinical studies were performed to evaluate the diagnostic performance of the device itself (only to affirm substantial equivalence to a predicate), no specific ground truth (expert consensus, pathology, outcomes data, etc.) was used for this submission's approval. The "truth" for this submission is based on the predicate device's established performance and the E-CUBE 15's compliance with engineering and safety standards.

8. The Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set." Therefore, no sample size for a training set is reported.

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

Since there is no mention of a training set, no information is provided on how its ground truth would have been established.

Summary of Device Approval Approach:

The approval for the E-CUBE 15 appears to be based on the substantial equivalence pathway. This means the manufacturer demonstrated that the E-CUBE 15 is as safe and effective as a legally marketed predicate device (E-CUBE 9, K120060) and complies with relevant performance and safety standards. For this type of submission (ultrasound imaging system, not a novel diagnostic algorithm), extensive new clinical performance data or studies directly comparing its diagnostic accuracy to ground truth are often not required if substantial equivalence can be demonstrated through technical and non-clinical testing, and comparison with a predicate.

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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); Small Organ (breast, testes, thyroid); Trans-rectal(TR); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE 15 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.

The Alpinion Medical Systems E-CUBE 15 is an ultrasound imaging system that was cleared through the FDA 510(k) pathway in 2012.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the E-CUBE 15 are primarily based on demonstrating substantial equivalence to its predicate device, the E-CUBE 9 (K120060). This means the E-CUBE 15 must be as safe and effective as the predicate device for its stated indications for use.

The document highlights the following performance aspects of the E-CUBE 15, compared to the predicate E-CUBE 9:

2. Sample Size for Test Set and Data Provenance

The summary explicitly states: "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence." This indicates that there was no test set of patient data used for clinical evaluation. The comparison was primarily based on technical specifications and adherence to recognized standards.

3. Number of Experts for Ground Truth and Qualifications

Since no clinical studies were performed, there were no experts establishing ground truth for a test set of patient data.

4. Adjudication Method

As no clinical studies were performed with a test set requiring interpretation, no adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted, as the device did not require clinical studies. The submission does not discuss human reader improvement with or without AI-assistance, as this is a diagnostic ultrasound system, not an AI-driven image analysis tool.

6. Standalone Performance Study

No standalone performance study of an algorithm (human-in-the-loop performance) was performed, as this is a medical imaging device and not an AI/algorithm-only device. The evaluation focused on the system as a whole and its components meeting established safety and performance standards.

7. Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was effectively the technical specifications, safety and performance characteristics of the predicate device (E-CUBE 9), and adherence to medical device safety standards. The substantial equivalence argument relies on showing that the E-CUBE 15 performs equivalently or better in essential aspects for its intended use, and any differences do not raise new questions of safety or effectiveness.

8. Sample Size for Training Set

The document does not mention any training set. As the device is a diagnostic ultrasound system and not an AI/machine learning product requiring data for model training, the concept of a training set as typically understood in AI/ML is not applicable here.

9. How Ground Truth for Training Set Was Established

Not applicable, as there was no training set.

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