Search Results

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); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

E-CUBE inno product is a mobile ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with ergonomic control panel with easy user interface, optimal image quality.

The information provided describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE inno ultrasonic pulsed Doppler imaging system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy against acceptance criteria.

Therefore, many of the requested items related to clinical studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established, type of ground truth used) are not applicable in this context, as the equivalence was primarily based on non-clinical tests and a comparison of features and indications for use.

Here's the breakdown of the information that can be extracted:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context refer to demonstrating that the E-CUBE inno is substantially equivalent to its predicate device (LOGIQ i, LOGIQ e, Vivid e, specifically LOGIQ e is used for comparison in the table) in terms of indications for use, material, form factor, performance, and safety characteristics. The "reported device performance" is the comparison of these characteristics between the proposed device and the predicate.

Table of Acceptance Criteria (Substantial Equivalence Comparison) and Reported Device Performance

Overall Conclusion of Equivalency:
The submitter concludes that the E-CUBE inno is substantially equivalent to the predicate device, despite some differences in indications for use, weight, console design components (like battery), and specific operating modes/accessories. These differences are deemed not to affect the essential performance or safety and effectiveness of the device. The primary differences are attributed to "cosmetic structure and component used only."

Study that Proves the Device Meets the Acceptance Criteria:

This submission is a 510(k) for an ultrasound imaging system. For such devices, clinical studies explicitly proving performance against pre-defined acceptance criteria (like accuracy, sensitivity, specificity for a diagnostic algorithm) are often not required if substantial equivalence to a predicate device can be demonstrated through other means.

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

Instead, the demonstration of substantial equivalence relies on:

1. Comparison to a Legally Marketed Predicate Device: The E-CUBE inno was compared feature-by-feature to the GE Healthcare LOGIQ e (K113690) to show that it has similar technological characteristics and indications for use.
2. Summary of Non-Clinical Tests:
   • Evaluations for biocompatibility (for patient contact materials/transducers).
   • Acoustic output.
   • Thermal, electrical, electromagnetic, and mechanical safety.
   • Conformity to applicable medical device safety standards:
     • NEMA UD2, UD3
     • AIUM Medical Ultrasound Safety
     • IEC60601-1
     • IEC60601-1-2
     • IEC60601-2-37
     • ISO 10993-1
   • Application of quality management system measures during development.

Additional Requested Information (Not Applicable or Not Provided for this type of submission):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable. No clinical test set data was provided or required for this 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable.
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: Not Applicable. This is a basic ultrasound imaging system, not an AI-assisted diagnostic device, and no MRMC studies were conducted for this 510(k).
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable. This is a hardware/software system, and its performance is evaluated as a whole in comparison to a predicate, not as a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Applicable.
7. The sample size for the training set: Not Applicable. No training set for an AI algorithm was mentioned or relevant to this 510(k).
8. How the ground truth for the training set was established: Not Applicable.

Ask a specific question about this device