(46 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The GE Voluson S6/S8 Ultrasound System is a general-purpose imaging and analysis system. The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.
Therefore, this document does not contain explicit acceptance criteria tables with reported device performance metrics like sensitivity or specificity, nor does it detail a clinical study designed to "prove the device meets acceptance criteria" in terms of algorithm performance for specific medical tasks. Instead, it describes non-clinical tests and affirms the device's technical equivalence and safety to its predicates.
Based on the provided text, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical study. The device is a diagnostic ultrasound system, whose performance is generally assessed through imaging quality, safety, and functionality, rather than specific diagnostic accuracy metrics, which would typically be evaluated in a clinical study if new diagnostic indications or automated analysis features were being introduced.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable to a clinical study demonstrating performance against acceptance criteria. The document explicitly states: "The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 1)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. No clinical study data for ground truth establishment is presented.
4. Adjudication Method for the Test Set:
Not applicable. No clinical study data for ground truth establishment is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a general diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
Not applicable. The device is a diagnostic ultrasound system that requires a human operator for image acquisition and interpretation. It is not an algorithm-only device.
7. The Type of Ground Truth Used:
Not applicable, as no dedicated clinical study assessing diagnostic performance against a ground truth is described. The "ground truth" for this type of submission relies on the established safety and performance of its predicate devices and compliance with regulatory standards.
8. The Sample Size for the Training Set:
Not applicable. As this device is not an AI/algorithm-based diagnostic product with a training set in the conventional sense, no training data or sample size is relevant for this submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
Summary of Device Evaluation (from the provided text):
The GE Voluson S6, Voluson S8 Ultrasound System underwent non-clinical tests to demonstrate substantial equivalence to its predicate devices, covering:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
The development process also included standard quality assurance measures such as:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final Acceptance Testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
The conclusion states that GE Healthcare considers the Voluson S6, Voluson S8 to be as safe, as effective, and its performance substantially equivalent to the predicate device(s). The FDA concurred with this finding of substantial equivalence based on the provided information, without requiring clinical studies.
The tables in pages 6-19 list the various clinical applications and modes of operation for the Voluson S6/S8 system with different transducers. "P" indicates applications and modes previously cleared by FDA, while "N" indicates new indications. These tables specify the intended uses and capabilities of the device and its transducers, rather than presenting acceptance criteria for a performance study.
§ 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.