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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 7 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 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 7 Ultrasonic Pulsed Doppler Imaging System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or standalone testing.

Instead, the submission leverages substantial equivalence to a predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). This means the manufacturer is asserting that the E-CUBE 7 is as safe and effective as the already-marketed predicate device, and therefore does not require new clinical studies to demonstrate performance.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the E-CUBE 7 beyond conforming to general safety standards. The document states:

"E-CUBE 7 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 7 and its application comply with voluntary standards as detailed in this premarket submission."

The submission focuses on comparing the E-CUBE 7's technology to its predicate device, stating:

"E-CUBE 7 employs the same fundamental scientific technology as its predicate device."
"Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy. So there is no significant difference in essential performance, safety and effectiveness with the predicate device and the image parameter functions do not change the intended use."

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

No test set sample size, data provenance, or details about patient data (e.g., country of origin, retrospective/prospective) are mentioned. The application explicitly states that clinical studies were not required.

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 or test sets with ground truth established by experts were conducted or reported in this 510(k) summary.

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

Not applicable, as no clinical studies or test sets requiring adjudication were conducted or reported.

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 device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool, and no MRMC study was performed or reported.

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

Not applicable. This is a standalone ultrasound imaging system, not an algorithm, and its performance is considered substantially equivalent to a predicate device without the need for independent standalone performance studies in this submission.

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

Not applicable, as no clinical studies requiring ground truth establishment were conducted or reported.

8. The sample size for the training set

Not applicable, as this is a medical imaging device for which "training sets" in the context of machine learning are not mentioned or relevant to the substantial equivalence argument presented.

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

Not applicable, for the same reasons as point 8.

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