(29 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application/Anatomy/Region of Interest: Fetal / Obstetrics; Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (includes urology/prostate); Transvaginal.
The systems are full-featured Track 3 ultrasound systems primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.
The provided text is a 510(k) Pre-Market Notification submission for the GE Healthcare Voluson S6, Voluson S8, and Voluson S10 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices ([K141639](https://510k.innolitics.com/search/K141639), [K152567](https://510k.innolitics.com/search/K152567), and [K142472](https://510k.innolitics.com/search/K142472)) and does not contain detailed information about acceptance criteria and a study proving the device meets those criteria, as one would expect from a de novo submission or a more comprehensive performance study report.
Instead, the submission states that "The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence." This indicates that the device's performance was deemed substantially equivalent to a predicate device based on non-clinical tests and technological comparisons, rather than new clinical trials with specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies are not present in this document. The document argues for equivalence based on:
- Intended Use, Imaging Capabilities, and Technological Characteristics: Stating they are the same as or similar to the predicate devices.
- Compliance with Safety Standards: Listing various ISO, IEC, AAMI/ANSI, and NEMA standards.
- Quality Assurance Measures: Mentioning risk analysis, requirements reviews, design reviews, and various levels of testing.
- Biocompatibility: Stating that patient contact materials are biocompatible.
Given this, I will answer the questions based on the information available in the document, explicitly stating when details are not provided.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence based on a predicate device, specific performance acceptance criteria for new clinical studies are not explicitly stated. The device is deemed to meet acceptance criteria by demonstrating substantial equivalence to predicate devices. The "performance" reported is therefore equivalence, rather than reaching specific quantitative thresholds.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K141639, K152567, K142472) in: | Demonstrated. |
| - Intended Use | "The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis." The intended use remains the same as previously cleared (e.g., Fetal/OB, Abdominal, Pediatric). |
| - Imaging Capabilities | "The Voluson S6/S8/S10 and predicate Voluson S6/S8 systems have the same clinical intended use" and "the same imaging modes." Minor changes in transducers, with new transducers similar to those on predicate devices. |
| - Technological Characteristics | "The Voluson S6 / Voluson S8 / Voluson S10 employs the same fundamental scientific technology as its predicate devices." Adds software features and beam former cleared with previous 510(k)s. |
| - Safety and Effectiveness | "The Voluson S6 / Voluson S8 / Voluson S10 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness." Compliance with various safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM). Acoustic output levels are below FDA limits. Biocompatible materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission explicitly states, "The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set with human subject data for a new clinical study. The evaluation focused on non-clinical tests and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical studies requiring expert ground truth were conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical studies requiring expert adjudication were conducted for this 510(k) submission.
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 device is an ultrasound system with imaging modes and software features; it is not an AI-assisted diagnostic tool for which an MRMC study on human reader performance improvement would typically be conducted. The submission focuses on the safety and technological equivalence of the ultrasound system itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical imaging device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests and comparisons, the "ground truth" would be the established safety standards and the performance specifications of the predicate devices. For instance, acoustic output levels were compared against applicable FDA limits (NEMA UD 3, NEMA UD 2), and material biocompatibility was evaluated against ISO10993-1. These are objective engineering and regulatory standards rather than clinical ground truth derived from expert consensus, pathology, or outcomes data in the context of a new clinical study.
8. The sample size for the training set
Not applicable. The document describes a medical imaging device (ultrasound system), not an AI/ML algorithm that would typically have a training set. The "development" mentioned refers to engineering and quality assurance processes, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML algorithm in this context.
§ 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.