(35 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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 5 product is an ultrasound imaging system for medical diagnosis. The 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.
Modes of operation:
- Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI) - 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 acceptance criteria and the study conducted for the ALPINION MEDICAL SYSTEMS Co., Ltd.'s E-CUBE 5 Diagnostic Ultrasound System.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative way. Instead, it states that the E-CUBE 5's safety, effectiveness, and essential performance are considered substantially equivalent to the predicate device (E-CUBE 7) based on non-clinical testing and conformance to applicable medical device safety standards.
Acceptance Criteria (Implied from the document):
- Conformance to applicable medical device safety standards (e.g., NEMA UD2, UD3, AIUM Medical Ultrasound Safety, IEC60601-1, IEC60601-1-2, IEC60601-2-37).
- Biocompatibility of transducer materials and other patient contact materials.
- Evaluation of acoustic output.
- Evaluation of thermal, electrical, electromagnetic, and mechanical safety.
- Performance, technology, and software are substantially equivalent to the predicate device (E-CUBE 7).
Reported Device Performance (Implied from the document):
- The E-CUBE 5 was found to conform to the listed applicable medical device safety standards.
- Transducer materials and patient contact materials are biocompatible.
- Non-clinical testing verified design changes compared to the predicate device.
- The differences between E-CUBE 5 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 5.
2. Sample size 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 5, did not require clinical studies to support substantial equivalence." This means no clinical test set was used to evaluate the device's performance in humans. The evaluation was based on non-clinical tests. Therefore, there is no information on sample size or data provenance for a clinical test set.
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)
Since no clinical studies were performed, there are no experts or ground truth established from human data as part of a clinical test set. The validation was based on non-clinical engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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. This is not an AI/CAD device. The submission does not mention any MRMC study or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a diagnostic ultrasound system, not an algorithm being evaluated in isolation. The evaluation was for the entire system and its transducers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established by reference to engineering specifications, national and international safety standards, and established metrics for acoustic output and electrical safety. For example, for biocompatibility, the ground truth would be established by laboratory tests conforming to ISO standards for material compatibility.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The evaluation is for a diagnostic ultrasound system based on its hardware and software design, and adherence to safety and performance standards.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.