(15 days)
The SONOACE R3 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Trans-rectal, trans-vaginal, Muscular-Skeletal (conventional, Superficial), Cardiac Adult and Peripheral-vessel.
The SONOACE R3 is a general purpose, portable, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes. The SONOACE R3 also gives the operator the ability to measure annomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R3 has real time acoustic output display with two basic indices, a mechanical index and a thermised index, which are both automatically displayed.
The provided text describes the SONOACE R3 Diagnostic Ultrasound System and its intended uses, primarily focusing on general safety and function. It states that the device is "substantially equivalent" to predicate devices (SONOACE X6 and SONOACE PICO) and lists various safety and acoustic output standards it meets.
However, the provided text does not contain any information about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) related to its diagnostic capabilities, nor does it include information about AI/algorithm performance.
The tables detailing clinical applications and modes of operation for the main system and specific transducers (C2-4/20, CN2-8, CN4-9, EC4-9, L5-12/60, LN5-12/40) merely indicate which applications each can be used for ("N" for new indication, "P" for previously cleared). This is about intended use, not performance metrics or acceptance criteria for diagnostic efficacy.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies, which are not detailed here.
Here's a breakdown of what can be extracted, and what is missing:
Information from the document:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (General): The device has been designed to meet several product safety standards (UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157, ISO10993-1). These are primarily safety and technical performance standards, not diagnostic performance metrics.
- Reported Device Performance: The document states the device is "substantially equivalent" to predicate devices (K081676, SONOACE X6 Diagnostic Ultrasound System; K061213, SONOACE PICO Diagnostic Ultrasound System). This means its performance is considered equivalent to these previously cleared devices, but no specific performance metrics like sensitivity, specificity, or accuracy are provided.
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. There is no indication of AI or human reader studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. There is no indication of an algorithm or AI.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
- 8. The sample size for the training set: Not mentioned. (Not applicable as no AI/algorithm is described).
- 9. How the ground truth for the training set was established: Not mentioned. (Not applicable as no AI/algorithm is described).
Missing Information (and why it's missing from this document):
The provided document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. For devices like this, especially back in 2010, the primary focus of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical performance studies with detailed statistical metrics, ground truth establishment, or AI algorithm validation. The "acceptance criteria" here are mainly about meeting recognized safety and functional standards, and the "study" is the demonstration of substantial equivalence in form and function.
For AI-enabled medical devices, clinical performance studies with the requested details (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) would typically be required in a more recent submission, and would be a separate, much more detailed section of the regulatory filing. This document predates the common inclusion of such detailed AI performance data in 510(k) summaries.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.