(74 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular 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.
Here's a summary of the acceptance criteria and study information for the GE Vivid S5/S6 Diagnostic Ultrasound System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) Summary) for the GE Vivid S5/S6 is a premarket notification for a modification to an already legally marketed device. It does not present specific quantitative acceptance criteria or detailed performance metrics in the typical sense of a clinical or analytical performance study. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to its predicate device (Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K092079).
The reported device performance is that it meets this substantial equivalence:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable type to predicate device | The modified Vivid S5/S6 is of a comparable type to the current Vivid S5/S6. |
| Substantially equivalent to predicate device | The modified Vivid S5/S6 is substantially equivalent to the current Vivid S5/S6, having the same overall characteristics, key safety and effectiveness features, physical design, construction, materials, and intended uses and operating modes. It also has additional software features similar to other cleared GE Ultrasound systems. |
| Conforms with applicable medical device safety standards | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. Compliance is verified through independent evaluation with ongoing factory surveillance. |
| Complies with voluntary standards | The modified Vivid S5/S6 and its applications comply with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission. |
| Risk analysis conducted | Risk analysis conducted. |
| Requirements Reviews conducted | Requirements Reviews conducted. |
| Design Reviews conducted | Design Reviews conducted. |
| Testing on unit level (Module verification) | Testing on unit level (Module verification) conducted. |
| Integration testing (System verification) | Integration testing (System verification) conducted. |
| Final Acceptance Testing (Validation) | Final Acceptance Testing (Validation) conducted. |
| Performance testing (Verification) | Performance testing (Verification) conducted. |
| Safety testing (Verification) | Safety testing (Verification) conducted. |
| Transducer and patient contact materials are biocompatible | Transducer materials and other patient contact materials are biocompatible. |
| Intended uses and key features consistent with clinical practice, FDA guidelines, and established methods | Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. |
| Design and development process conforms with 21 CFR 820 and ISO13485 quality systems | The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence."
Therefore, there is no separate "test set" in the context of clinical performance evaluation described here. The evaluation relies on non-clinical tests (acoustic output, biocompatibility, safety, etc.) and comparison to the predicate device.
3. Number of Experts and Qualifications for Ground Truth
Not applicable, as no clinical studies requiring expert-established ground truth were performed for this specific submission to demonstrate substantial equivalence.
4. Adjudication Method
Not applicable, as no clinical studies requiring adjudication were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence based on technical specifications and non-clinical testing, not on improved human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is an ultrasound system, not an AI algorithm intended for standalone performance evaluation in the context of this 510(k) submission. The document mentions "additional software features that are similar to other cleared GE Ultrasound systems," but does not detail any standalone performance studies for these features.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for this device relies on:
- Compliance with established safety and performance standards: Non-clinical tests (acoustic output, biocompatibility, electrical, thermal, mechanical safety).
- Comparison to predicate device specifications and performance: The existing cleared Vivid S5/S6 (K092079) serves as the benchmark for "truth" in terms of equivalence.
8. Sample Size for the Training Set
Not applicable, as this submission is for an ultrasound system based on established technology and substantial equivalence, not a new AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI model training set in this submission.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.