Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
The provided document is a 510(k) premarket notification summary for a diagnostic ultrasound system. It outlines the device description, indications for use, comparison to predicate devices, and the non-clinical tests performed. Crucially, the document states "Not applicable" for clinical studies and explicitly says, "The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, based on the provided text, there is no information available regarding acceptance criteria and a study that proves the device meets those criteria in the context of an "AI" or "software" performance evaluation as typically seen for AI/ML-enabled devices. The new features mentioned (e.g., Super Resolution CEUS, Smart Scene) are presented as improvements or enhancements based on cleared functions, or new options that passed related tests without introducing new clinical risks. The focus of this 510(k) is on demonstrating substantial equivalence to predicate ultrasound devices through non-clinical testing and shared technological characteristics.
Here's why the requested information cannot be provided from this document:
- No AI/ML Performance Claim: The document does not describe the device as an AI/ML-enabled diagnostic tool in the sense of providing automated analysis, detection, or diagnosis that would require specific performance metrics like sensitivity, specificity, or AUC based on ground truth. The "Smart Calc" feature mentioned is simply an analysis package.
- Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new ultrasound system is substantially equivalent to existing, legally marketed predicate devices primarily through engineering, safety, and functionality comparisons.
- No Clinical Study Performed/Required: The document explicitly states that clinical studies were "Not applicable" and "not required to support substantial equivalence." This means there was no de novo performance study with a test set, ground truth, or expert readers to evaluate specific diagnostic accuracy or AI assistance.
Table of Acceptance Criteria and Reported Device Performance (as inferable from the document's scope):
| Acceptance Criterion (Inferable) | Reported Device Performance (as stated or implied) |
|---|---|
| Acoustic Output below FDA Limits | Acoustic power levels are below FDA limits, "which are the same as the predicated devices Resona R9 (K222928) and ZS3(K192410)." |
| Compliance with Electrical and Physical Safety Standards | Designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, IEC 62304, IEC 62366-1). |
| Biocompatibility | Patient contact materials of transducers and needle-guided brackets are the same as predicate devices or "tested under ISO 10993-1." |
| Cleaning and Disinfection Effectiveness | Evaluated for cleaning and disinfection effectiveness. |
| Intended Uses Comparable to Predicate Devices | Has the same intended uses as the predicate device Resona R9 (K222928), with Ophthalmic and GYN/Pelvic applications cleared in predicate device ZS3 (K192410). Applicable for adults, pregnant women, pediatric patients and neonates for various exams. |
| Imaging Modes and Features Comparable to Predicate Devices | Includes B, M, PWD, CWD, Color Doppler, Power Doppler, Combined modes, Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D, Strain Elastography, STE, STQ, Contrast imaging (for LVO and Liver). These are stated to be comparable with predicate devices. |
| New Features (e.g., Super Resolution CEUS, STVi, Arterial PWV Analysis) | New options are improvements/enhancements based on cleared functions, "no intended uses are added and passed the related tests, no clinical risks introduced." Specific functions are explained (e.g., Super Resolution CEUS for acquiring more contrast image data, STVi for calculating viscosity/frequency dispersion, Arterial PWV for pulse wave velocity). These additions appear to have been accepted as not altering the fundamental substantial equivalence or safety profile, rather than requiring specific performance metrics against an independent ground truth. |
| Quality System Compliance | Manufacturer confirms compliance with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
Regarding the specific questions about an AI/ML performance study, the answers are "N/A" (Not Applicable) because such a study was not performed or required for this 510(k) clearance:
- A table of acceptance criteria and the reported device performance: See table above for inferable, non-AI criteria.
- Sample sized used for the test set and the data provenance: N/A (no clinical test set for AI performance).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: No MRMC study for AI assistance was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was performed.
- The type of ground truth used: N/A.
- The sample size for the training set: N/A (no mention of a training set for an AI model).
- How the ground truth for the training set was established: N/A.
§ 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.