(29 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The GE Vivid S5/S6 is a mobile ultrasound console having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular a and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
The provided document is a 510(k) Premarket Notification for the GE Vivid S5/S6 Diagnostic Ultrasound system, dated July 18, 2007. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information requested regarding acceptance criteria based on clinical studies, sample sizes for test and training sets, expert adjudication, or MRMC studies is not typically part of this type of submission.
The document explicitly states: "Clinical Tests: None required."
However, I can extract the general acceptance criteria and the type of studies conducted to support the device's substantial equivalence to the predicate device, the GE Vivid 3 Ultrasound System (K020789).
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific numerical acceptance criteria or performance metrics from clinical studies are reported, the table will reflect the general safety and performance evaluation conducted for the 510(k) submission. The acceptance criteria here refer to compliance with safety standards and substantial equivalence to the predicate device.
| Acceptance Criterion (General) | Reported Device Performance/Compliance |
|---|---|
| Device substantially equivalent to predicate device | The GE Vivid S5/S6 is of a comparable type and substantially equivalent to the currently marketed GE Vivid 3. It has the same intended uses as the predicate device. Its overall construction, materials, and performance are equivalent, although it is smaller and lighter. |
| Compliance with medical device safety standards | Evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. Found to conform with applicable medical device safety standards. |
| Compliance with quality systems | Design and development process conforms with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document explicitly states "Clinical Tests: None required." The submission relies on non-clinical tests and comparison to a predicate device for substantial equivalence.
- Data Provenance: Not applicable for clinical test data. Non-clinical evaluations were conducted by GE Healthcare and independent evaluation with ongoing factory surveillance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set requiring expert-established ground truth was reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was reported.
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 a 2007 submission for an ultrasound system, not an AI-assisted diagnostic device. No MRMC comparative effectiveness study was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. The "ground truth" for this submission is based on adherence to recognized medical device safety standards and the established performance and safety record of the predicate device (GE Vivid 3).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that uses a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.