Search Results
Found 1 results
510(k) Data Aggregation
(93 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); 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.
- 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
- 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.
| Acceptance Criteria Category | Specific Criteria / Performance Target | Reported Device Performance (E-CUBE i7) |
|---|---|---|
| Indications for Use | Must be substantially equivalent or expanded upon predicate devices. | Expanded indications compared to K121937 (E-CUBE inno) by adding "Adult Cephalic", "Trans-rectal", "Trans-vaginal", "Cardiac Pediatric". Substantially equivalent to K150773 (E-CUBE 15) and K151663 (RS80A) for all broad categories. |
| Safety Standards Compliance | Conformity to specific medical device safety standards. | Conforms to NEMA UD2, UD3; AIUM Medical Ultrasound Safety; IEC60601-1; IEC60601-1-2; IEC60601-2-37; ISO10993-1; ISO14971. |
| Biocompatibility | Patient contact materials must be biocompatible. | Transducer materials and other patient contact materials are biocompatible. |
| Acoustic Output | Must meet specified limits for medical ultrasound equipment. | Evaluated for acoustic output (Track 3). |
| Electrical Safety | Must conform to relevant electrical safety standards. | Conforms to IEC60601-1 and IEC60601-1-2. |
| Electromagnetic Compatibility (EMC) | Must conform to relevant EMC standards. | Conforms to IEC60601-1-2. |
| Mechanical Safety | Must conform to relevant mechanical safety standards. | Evaluated for mechanical safety. |
| Imaging Modes | Must include equivalent or enhanced imaging capabilities compared to predicate. | Includes 2D (B), M, Anatomical M, Color Flow (CF), Power Doppler (PD), Directional PD, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Tissue Doppler Imaging (TDI). Adds Anatomical M, Directional PD, TDI (compared to K121937). |
| Image Processing Technology | Must include equivalent or enhanced image processing compared to predicate. | Includes Xpeed™, Full SRI™, Spatial Compounding Image (SCI). Adds Spatial Compounding Image (SCI) compared to K121937. Adds High PRF Doppler compared to K150773. |
| Software Features | Must include equivalent or enhanced software features compared to predicate. | Includes Panoramic, Needle Vision™/Needle Vision™ Plus, Cube View™. Adds Panoramic, Needle Vision™/Needle Vision™ Plus, Cube View™ compared to K121937. |
| Transducer Compatibility | Must be compatible with transducers with similar performance characteristics and clinical applications as predicate devices. | Demonstrates compatibility with 9 transducers (C1-6T, L3-12T, EC3-10T, EV3-10T, I08-17T, SP1-5T, SP3-8T, C5-8NT) and lists their intended usage and operating modes, showing equivalence or expansion to predicate transducers. |
| Quality Management System | Evidence of robust development process. | Applied quality management measures including Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), Design Validation. |
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.
Ask a specific question about this device
Page 1 of 1