(100 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); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 7 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 provided 510(k) summary for the E-CUBE 7 Ultrasonic Pulsed Doppler Imaging System states that clinical studies were not required to support substantial equivalence to its predicate device, the E-CUBE 9 Diagnostic Ultrasound System (K120060).
Therefore, the following information regarding acceptance criteria and performance study details cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
- Sample size used for the test set and the data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts involved in establishing ground truth for a clinical test.
- Adjudication method for the test set: No adjudication method specified as there was no clinical test set.
- 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: No MRMC study was conducted. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool for reading improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was assessed for diagnosis.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No clinical ground truth was established for a performance study.
- The sample size for the training set: No training set was used for an AI/machine learning model.
- How the ground truth for the training set was established: No ground truth for a training set was established.
Summary based on the provided document:
The E-CUBE 7 was deemed substantially equivalent to its predicate device, E-CUBE 9, based on non-clinical tests and the same fundamental scientific technology.
Non-clinical tests performed include:
- Biocompatibility
- Acoustic output
- Thermal safety
- Electrical safety
- Electromagnetic safety
- Mechanical safety
The device was found to conform to applicable medical device safety standards and complies with voluntary standards. Quality management system measures applied to its development include: Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation. Transducer materials and other patient contact materials are also stated to be biocompatible.
§ 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.