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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 i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D

B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

The provided text describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasound system. This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a novel device with specific acceptance criteria that require proof through a new study.

Therefore, there is no specific study mentioned in this document that proves the device meets particular acceptance criteria in the format requested. The document asserts substantial equivalence based on comparisons to predicate devices and adherence to established safety and performance standards.

Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly defined by the safety and performance characteristics of the predicate devices and relevant industry standards. The "reported device performance" is essentially the statement that the E-CUBE i7 is equivalent in performance to these predicates.

The document states, "Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance." This is the core "proof" in a 510(k) context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set, sample size, or data provenance information of this nature provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies with test sets were conducted.

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

Not applicable, as no clinical studies with test sets 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. The E-CUBE i7 is an ultrasound imaging system, and the submission does not mention any AI assistance features or MRMC studies.

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

Not applicable, as the device is a diagnostic ultrasound system and not an algorithm-only device. Performance assessment is based on demonstrating equivalence to predicate ultrasound systems through engineering and performance testing against standards, not through standalone algorithm performance studies.

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

Given that no clinical studies were performed, there's no clinical "ground truth" established in this submission. The "ground truth" for demonstrating substantial equivalence relies on:

• Engineering principles and design specifications.
• Performance testing against recognized standards (e.g., NEMA UD2, AIUM Medical Ultrasound Safety, IEC 60601 series).
• Comparison of features and specifications to legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning/AI models are discussed that would require a training set in the context of this submission. The device is an ultrasound imaging system.

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

Not applicable.

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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 (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

1. Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode
2. Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasonic pulsed doppler imaging system (K153424):

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel device's primary clinical efficacy study. Therefore, the "acceptance criteria" discussed here are primarily related to safety, performance, and equivalence to existing devices, not necessarily a clinical effectiveness threshold. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to confirm compliance with recognized medical device standards and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are predominantly compliance with recognized standards and equivalence in features and performance to predicate devices. The "reported device performance" is demonstrated by affirming compliance and similarity.

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

• Sample Size: The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence." This means there was no clinical test set of patients or images used for efficacy comparison. The "test set" for this submission primarily consisted of the device itself and its components tested against engineering and safety standards.
• Data Provenance: Not applicable for a clinical test set in this context. The data provenance would be internal engineering tests and design documentation.

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

• Not applicable as there was no clinical study involving human reads or a ground truth established by experts for a test set. This submission is based on engineering verification and validation (V&V) against technical standards and comparison to predicate devices, which involves engineers, quality assurance personnel, and regulatory specialists.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC study was done. This device is an ultrasonic imaging system, not an AI-assisted diagnostic tool. Its substantial equivalence is based on its core imaging capabilities and safety, not on improving human reader performance.

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

• No standalone algorithm performance study was done. The E-CUBE i7 is a diagnostic ultrasound system intended to be operated by a qualified physician, not an autonomous algorithmic device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the adherence to established international and national medical device standards (e.g., IEC, NEMA, AIUM, ISO) for safety and performance, and the documented specifications and performance of legally marketed predicate devices. This is established through engineering testing and documented comparisons, rather than clinical outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a hardware and software system, not a machine learning model that would require a "training set" of data.

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

• Not applicable. There was no training set for a machine learning model.

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