(120 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 (Superculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 11 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
The provided text describes the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 11 ultrasound system, a Class II medical device, and its substantial equivalence to predicate devices, focusing on technical characteristics and safety standards rather than human performance studies or detailed acceptance criteria with reported device performance.
Therefore, the following information cannot be fully extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states: "The subject of this premarket submission, E-CUBE 11, did not require clinical studies to support substantial equivalence." This indicates that no new clinical efficacy studies evaluating device performance against acceptance criteria were conducted or presented in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices by comparing technical specifications, imaging modes, and adherence to safety standards.
However, I can provide the acceptance criteria in terms of the standards and features the device conforms to, as reported in the "Summary of Non-Clinical Tests" and "Determination of Substantial Equivalence" sections.
1. Table of Acceptance Criteria (as per conformance to standards and features) and the Reported Device Performance (as stated in the summary of non-clinical tests and comparison to predicates):
| Acceptance Criteria (Conformance to Standards/Features) | Reported Device Performance (Stated Conformance/Equivalence) |
|---|---|
| Safety and Performance Standards | |
| IEC 60601-1 (General Electrical Safety) | Conforms to IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety |
| IEC 60601-1-2 (EMC Requirements) | Conforms to IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests |
| IEC 60601-2-37 (Ultrasonic Medical Equipment Safety) | Conforms to IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment |
| ISO 10993-1 (Biocompatibility) | Conforms to ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing; Transducer materials and other patient contact materials are biocompatible. |
| ISO 14971 (Risk Management) | Conforms to ISO14971, Application of risk management to medical devices |
| AIUM Medical Ultrasound Safety | Conforms to AIUM Medical Ultrasound Safety |
| NEMA UD 2 (Acoustic Output Measurement) | Conforms to NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3 (Real-Time Acoustic Output Display) | Conforms to NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment |
| Quality Management System Measures | |
| Medical Device Risk Management | Applied |
| Requirements Reviews | Applied |
| Design Reviews | Applied |
| Component Verification | Applied |
| Integration Review (System Verification) | Applied |
| Performance Testing (System Verification) | Applied |
| Safety Testing (Compliance Test) | Applied |
| Design Validation | Applied |
| Imaging Modes | (All listed modes are present, aligning with various predicate devices) |
| 2D(B) mode | Supported |
| Harmonic mode (HAR) | Supported |
| M mode | Supported |
| Color M mode | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| Anatomical M mode | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| Color Flow Doppler (CF) Mode | Supported |
| Power Doppler (PD) Mode | Supported |
| Directional PD mode | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| Pulsed Wave Doppler (PWD) Mode | Supported |
| Continuous Wave Doppler (CWD) Mode | Supported |
| High PRF Doppler mode | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| Tissue Doppler Imaging (TDI) Mode | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| 3D/4D mode | Supported (similar to E-CUBE 15 & 7, new compared to E-CUBE i7) |
| Imaging Functions (Advanced Features) | (All listed functions are present, aligning with various predicate devices) |
| Xpeed™ | Supported |
| Full SRI™ | Supported |
| Spatial Compounding Image (SCI) | Supported |
| Frequency Compounding image (FCI) | Supported (similar to E-CUBE 15 & 7, new compared to E-CUBE i7) |
| Panoramic | Supported |
| Stress Echo | Supported (similar to E-CUBE 15, new compared to E-CUBE i7 & 7) |
| Cube Strain™ | Supported (similar to E-CUBE 15, new compared to E-CUBE i7 & 7) |
| Live HQ™ | Supported (similar to E-CUBE 15, new compared to E-CUBE i7 & 7) |
| Needle Vision™ / Needle Vision™ Plus | Supported (similar to E-CUBE 15 & i7, new compared to E-CUBE 7) |
| Elastography | Supported (similar to E-CUBE 15, new compared to E-CUBE i7 & 7) |
| Cube view™ | Supported (similar to E-CUBE i7, new compared to E-CUBE 15 & 7) |
| Intended Use / Clinical Applications | (Indications for Use are listed as identical to predicate) |
| Fetal | Supported |
| Abdominal (renal & GYN/pelvic) | Supported |
| Pediatric | Supported |
| Small Organ (breast, testes, thyroid) | Supported |
| Adult Cephalic | Supported |
| Trans-rectal (TR) | Supported |
| Trans-vaginal (TV) | Supported |
| Musculo-skeletal (Conventional) | Supported |
| Musculo-skeletal (Superficial) | Supported |
| Cardiac Adult | Supported |
| Cardiac Pediatric | Supported |
| Peripheral Vessel (PV) | Supported |
| Urology (including prostate) | Supported |
2. Sample sized 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 11, did not require clinical studies to support substantial equivalence." Therefore, no specific test set sample size or data provenance from clinical studies is provided. The evaluation was based on non-clinical tests ensuring safety and performance compliance with standards and comparison to predicate devices' technical specifications.
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 expert-established ground truth were conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were conducted for this submission.
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 system, not an AI-assisted diagnostic tool, and no MRMC studies were conducted.
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, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with ground truth establishment were conducted for this submission.
8. The sample size for the training set
Not applicable, as the device is a diagnostic ultrasound system and no specific training set for an AI model is mentioned or relevant to this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is mentioned or relevant to this 510(k) submission.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.