(298 days)
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Nuscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The RS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study.
The document states:
- "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence."
- "Conclusion: Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the RS80A to be as safe, as effective, and performance is substantially equivalent to the predicate devices."
Therefore, the submission does not contain information about a study proving the device meets specific acceptance criteria in the manner usually associated with evaluating AI/ML-enabled devices (e.g., performance metrics compared against a predefined threshold). Instead, the substantial equivalence is established based on technological characteristics and compliance with recognized safety and performance standards.
However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the "device performance" as its declared characteristics and compliance.
Here's the information based on the provided text, structured to answer your questions where applicable. Please note that several points of your request pertain to clinical studies or AI/ML evaluations which are explicitly stated as "Not applicable" or not present in this type of submission for a diagnostic ultrasound system without a new AI component being evaluated for clinical accuracy.
1. Table of Acceptance Criteria (via Substantial Equivalence to Predicate Devices) and Reported Device Performance
The acceptance criteria here are implicitly met by demonstrating substantial equivalence to predicate devices (RS80A K151663 and Prosound F75 K140639) across various technological characteristics and intended uses. The "reported device performance" refers to the capabilities and specifications of the RS80A.
| Feature / Characteristic (Implicit Acceptance Criterion: Must be equivalent to predicate) | Predicate RS80A (K151663) | Predicate Prosound F75 (K140639) | Subject Device RS80A (Reported Performance) | Meets Criterion? |
|---|---|---|---|---|
| Intended Uses: | Yes in Predicate | Yes in Predicate | Yes in Subject Device | Implicitly Yes |
| Fetal/Obstetrics | √ | √ | √ | Yes |
| Abdominal | √ | √ | √ | Yes |
| Gynecology | √ | √ | √ | Yes |
| Pediatric | √ | √ | √ | Yes |
| Small Organ | √ | √ | √ | Yes |
| Neonatal Cephalic | √ | √ | √ | Yes |
| Adult Cephalic | √ | √ | √ | Yes |
| Trans-rectal | √ | √ | √ | Yes |
| Trans-vaginal | √ | √ | √ | Yes |
| Musculo-skeletal (Conventional & Superficial) | √ | √ | √ | Yes |
| Urology | √ | √ Note: Only in Subject & RS80A Predicate | Yes | |
| Cardiac Adult | √ | √ | √ | Yes |
| Cardiac Pediatric | √ | √ | √ | Yes |
| Peripheral vessel | √ | √ | √ | Yes |
| Scanhead Types: | ||||
| Linear Array | √ | √ | √ | Yes |
| Curved Linear Array | √ | √ | √ | Yes |
| Endocavity | √ | √ | √ | Yes |
| Phased Array | √ | √ | √ | Yes |
| Static Probes | √ | √ | √ | Yes |
| Scanhead Frequency: | ||||
| 1.0 ~ 20.0 MHz | √ | √ | √ | Yes |
| Modes of Operation: | ||||
| B-mode | √ | √ | √ | Yes |
| M-mode | √ | √ | √ | Yes |
| Pulsed wave (PW) Doppler | √ | √ | √ | Yes |
| Continuous wave (CW) Doppler | √ | √ | √ | Yes |
| Color Doppler | √ | √ | √ | Yes |
| Power Amplitude Doppler | √ | √ | √ | Yes |
| Tissue Harmonic Imaging | √ | √ | √ | Yes |
| 3D/4D imaging mode | √ | √ | √ | Yes |
| Combined modes | √ | √ | √ | Yes |
| Safety & EMC Compliance: | ||||
| IEC 60601-1 (AAMI ANSI ES60601-1) | √ | √ | √ | Yes |
| IEC 60601-1-2 (AAMI ANSI IEC 60601-1-2) | √ | √ | √ | Yes |
| IEC 60601-2-37 | √ | √ | √ | Yes |
| ISO 10993-1 | √ | √ | √ | Yes |
| ISO 14971 | √ | √ | √ | Yes |
| NEMA UD 2-2004 | √ | √ | √ | Yes |
| NEMA UD 3-2004 | √ | √ | √ | Yes |
| Functionality (Software Features): | ||||
| Q Scan | √ | √ | Yes (compared to K151663) | |
| ClearVision | √ | √ | Yes (compared to K151663) | |
| MultiVision (Spatial Compound Imaging) | √ | √ | √ | Yes |
| Panoramic | √ | √ | √ | Yes |
| Needle Mate | √ | √ | Yes (compared to K151663) | |
| Auto IMT+ (Auto IMT) | √ | √ | √ | Yes |
| Strain+ | √ | √ | √ | Yes |
| Stress Echo | √ | √ | √ | Yes |
| Arterial Analysis | √ | √ (eTRACKING) | √ (Adding new S/W feature) | Yes (similar functionality) |
| Elastoscan | √ | √ | √ | Yes |
| E-Thyroid | √ | √ | Yes (compared to K151663) | |
| E-Breast | √ | √ | Yes (compared to K151663) | |
| S-Shearwave | √ | √ | Yes (compared to K151663) | |
| S-Detect | √ | √ | Yes (compared to K151663) | |
| S-Fusion | √ | √ | Yes (compared to K151663) | |
| Clear Track | √ | √ | √ | Yes |
| Virtual Track | √ | √ | Yes (compared to K151663) | |
| ADVR | √ | √ | Yes (compared to K151663) | |
| 3D Imaging (Volume Data Acquisition) | √ | √ | √ | Yes |
| 3D Imaging presentation | √ | √ | Yes (compared to K151663) | |
| 3D Cine/4D Cine | √ | √ | Yes (compared to K151663) | |
| 3D Rendering | √ | √ | Yes (compared to K151663) | |
| MPR | √ | √ | Yes (compared to K151663) | |
| 3D XI MSV/Oblique View | √ | √ | Yes (compared to K151663) | |
| 3D MXI Volume Slice/Mirror View | √ | √ | Yes (compared to K151663) | |
| Volume CT | √ | √ | Yes (compared to K151663) | |
| 3D MagiCut | √ | √ | Yes (compared to K151663) | |
| Volume Calculation (VOCAL, XI VOCAL) | √ | √ | Yes (compared to K151663) | |
| XI STIC | √ | √ | Yes (compared to K151663) | |
| HDVI | √ | √ | Yes (compared to K151663) | |
| Realistic Vue | √ | √ | Yes (compared to K151663) | |
| Natural Vue | √ | √ | Yes (compared to K151663) |
Notes for above table:
- "P" in the original tables across pages 3-25 indicates "previously cleared by FDA K141620" for RS80A features (or K143089, K150478, K151663 for specific transducers). This essentially means the feature existed and was cleared in previous versions or related devices.
- The comparison specifically identifies "Arterial Analysis" as a new S/W feature for the RS80A (new in the subject device relative to K151663), but then states it's substantially equivalent to the "eTRACKING" of Hitachi's Prosound F75 (K140639) in regards to arterial analysis functionality. This feature "provides the user with vessel stiffness and strain information by measuring in vessel diameter."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence."
- Therefore, no specific clinical test set, sample size, or data provenance information is provided for evaluation of medical efficacy to demonstrate performance against acceptance criteria in a clinical setting. The evaluation focused on engineering and functional equivalence.
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 due to the absence of clinical studies evaluating the device against a ground truth for clinical outcomes. The submission relies on technological equivalence and compliance with standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable due to the absence of clinical studies.
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 submission is for a diagnostic ultrasound system (hardware and general software features), not specifically an AI/ML-enabled diagnostic algorithm that assists human readers and would typically require an MRMC study. The "Arterial Analysis" feature, while providing information, is not presented as an AI-driven interpretive tool that changes reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a medical device submission for an ultrasound system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of clinical performance. The "ground truth" for this submission focuses on compliance with technical and safety standards (e.g., IEC, ISO, NEMA) and functional equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm submission where a training set size would be relevant for performance evaluation in the described context.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document demonstrates substantial equivalence for the RS80A Diagnostic Ultrasound System based on a comparison of its technological characteristics, intended uses, and compliance with recognized safety and performance standards against two predicate devices (another RS80A model and Hitachi's Prosound F75). It explicitly states that clinical studies were not required for this submission. Therefore, detailed information on clinical acceptance criteria or a study proving clinical performance in the manner requested (e.g., using test sets, ground truth, expert adjudication, or MRMC studies) is not present in this 510(k) summary.
§ 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.