Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
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:
| Feature/Aspect | Predicate E-CUBE 9 | Proposed E-CUBE 15 | Discussion of Differences & Performance |
|---|---|---|---|
| Indications for Use | Extensive range, including Fetal, Abdominal, Pediatric, Small Organ, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac (adult & pediatric), Peripheral Vascular, Urology | Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes, thyroid); Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate). | E-CUBE 15 has a limited scope of indications compared to the predicate (e.g., no pediatric indication). However, the individual functions of E-CUBE 15 for its approved indications have "essential performance and safety effectiveness same as E-CUBE 9." This demonstrates equivalence for the specified uses. |
| Dimensions & Weight | Approx. 89.5kg, H: 1340/1600 mm, W: 590mm, D: 850mm | Approx. 105kg, H: 1413/1848 mm, W: 585mm, D: 670mm | Different. Not directly related to imaging performance or clinical effectiveness. |
| Monitor | 17" Wide LCD, 1366x768 display, 880x660 recording area | 18.5" Wide LCD, 1366x768 display, 880x660 recording area | Larger monitor on E-CUBE 15 (18.5" vs 17"). Display size and recording area are the same. This is considered an improvement in usability, not a difference in fundamental performance. |
| Electrical Power | Max. 600 VA | Max. 900 VA | Higher power for E-CUBE 15. This is likely due to the larger monitor and other potential component differences, but not explicitly linked to a change in imaging performance in the provided text. |
| Console Design | 3 active probe ports, 5 USB ports (Front 1, Back 4), Integrated HDD (500G), DVD-R/W, On-board storage for peripherals (B/W printer, Color Printer, DVD recorder), Control panel lift, 5 Transducer holders, Integrated Gel warmer, Front/Rear Handles, Wheel-lock, Thumbnail images, On-line Help key, ECG Module | 3 (4 optional) active Probe Ports, 8 USB ports (Touch module side 2, Back side 6), Touch panel, Integrated HDD (500G), DVD-R/W, On-board storage for peripherals (B/W printer, Color Printer, DVD recorder), Control panel lift, 5 Transducer holders, Integrated Gel warmer, Front/Rear Handles, Wheel-lock, Thumbnail images, On-line Help key, ECG Module | E-CUBE 15 offers more USB ports and an optional 4th probe port, plus a touch panel. These differences are stated to "not related with the safety, effectiveness and essential performance." |
| Operating Mode | B-Mode, M-Mode, Anatomical M-mode, PW Doppler (with High PRF), CW Doppler, Color Flow-Mode, Power Doppler Mode, THI, Tissue Doppler Imaging, Beam Steering, Panoramic B/CF, Spatial compounding, Frequency compounding, Xpeed on 2D/CF/PW, Auto IMT, Auto traces PW, Directional Power Doppler Mode, SRI, Full SRI, ECG, 3D/4D Volume Mode | B-Mode, M-Mode, Anatomical M-mode, PW Doppler (with High PRF), CW Doppler, Color Flow-Mode, Power Doppler Mode, THI, Tissue Doppler Imaging, Beam Steering, Panoramic B/CF, Spatial compounding, Frequency compounding, Xpeed on 2D/CF/PW, Auto IMT, Auto traces PW, Directional Power Doppler Mode, SRI, Full SRI, ECG | E-CUBE 15 does not include the 3D/4D Volume Mode found in the predicate. However, it is stated that "E-CUBE 15 includes essential operating mode for diagnosis and is Substantially Equivalent." |
| Measurement & Calculation Functions | General, Abdomen, Small Parts, Obstetrics, Gynecology, Cardiology, Vascular, Urology, Pediatrics | General, Abdomen, Small Parts, Obstetrics, Gynecology, Cardiology, Vascular, Urology | E-CUBE 15 does not include Pediatrics in its measurement and calculation functions, aligned with its reduced indications for use. This is stated to "not related with the safety, effectiveness and essential performance." |
| Acoustic Output | Track 3 | Track 3 | Match. Conforms to relevant standards. |
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.
Ask a specific question about this device
Page 1 of 1