(11 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic: Cardiac (adult and pediatric): Peripheral Vascular (PV): Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console approximately 65 cm deep and 139 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT display. This modification will provide users with enhanced ability to evaluate wall motion during echocardiography.
The provided document is a 510(k) premarket notification for the GE Vivid 7 Diagnostic Ultrasound System with new transducers and enhanced wall motion evaluation capability. It describes the device and claims substantial equivalence to an existing predicate device.
The critical information regarding acceptance criteria and an actual study proving the device meets those criteria is not present in the provided text. The document explicitly states: "2. Clinical Tests: None required."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details of a study using a test set, experts, adjudication methods, MRMC studies, or standalone algorithm performance.
However, I can extract information about the types of tests that were performed and other relevant details:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as specific performance metrics or thresholds for clinical effectiveness in this document. The primary "acceptance" is based on demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not provided as specific quantifiable performance data for the enhanced features or the overall system beyond general compliance with safety standards.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable, as no clinical tests were required or performed for this submission.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states "None required" for clinical tests.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: No, a standalone performance study was not performed or reported.
7. Type of Ground Truth Used:
- Ground Truth: Not applicable, as no clinical tests requiring a ground truth were performed. The basis for clearance is substantial equivalence to a legally marketed predicate device, along with non-clinical safety testing.
8. Sample Size for the Training Set:
- Sample Size: Not applicable, as the document does not describe the development or training of an AI algorithm in the context of this 510(k) submission. "TSI" likely refers to "Tissue Specific Imaging" or a similar ultrasound technology, not an AI model requiring a training set in the modern sense.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable.
Summary of what was done (Non-clinical tests):
The device underwent non-clinical tests to ensure safety and compliance with existing standards:
- Acoustic output evaluation
- Biocompatibility testing
- Cleaning and disinfection effectiveness
- Electromagnetic compatibility
- Thermal, electrical, and mechanical safety
These tests were reportedly found to conform with applicable medical device safety standards. The manufacturer's design and development process also conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. Compliance was verified through independent evaluation with ongoing factory surveillance.
The submission focuses on demonstrating that the modified GE Vivid 7 (with TSI) is substantially equivalent to the previously cleared GE Vivid 7, implying that existing clinical data and safety profiles of the predicate device are sufficient, and no new clinical studies were deemed necessary by the FDA for this particular 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.