(126 days)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
The RS85 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 Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS85 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 RS85 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's an analysis of the acceptance criteria and study information for the SAMSUNG MEDISON CO., LTD. RS85 Diagnostic Ultrasound System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the new device itself. As such, direct numerical acceptance criteria for performance (e.g., sensitivity, specificity) and a study proving the device meets those specific performance acceptance criteria are not explicitly stated in this document. Instead, the document relies on the equivalence of the RS85 to existing cleared devices and compliance with relevant standards.
Therefore, the tables below will reflect what is inferable from the document, which primarily focuses on demonstrating equivalence rather than establishing new performance benchmarks.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Standards) | Reported Device Performance (as stated or implied) |
|---|---|
| Intended Use: Consistent with diagnostic ultrasound imaging and fluid flow analysis of the human body for specified clinical applications. | The RS85 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel. 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 Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. |
| Technological Characteristics: Employs the same fundamental scientific technology as predicate devices. | The RS85 employs the same fundamental scientific technology as its predicate device(s). |
| Imaging Modes: Same as predicate RS80A systems, with the exception of MV-Flow and S-Shearwave Imaging deemed substantially equivalent to relevant predicates. | The RS85 and predicates RS80A systems have the same imaging modes with the exception of MV-Flow which is substantially equivalent to Samsung Medison RS80A (K171048), and S-Shearwave Imaging which is substantially equivalent to Samsung Medison RS80A (K171048) and SuperSonic Imagine Aixplorer (K132274). |
| Transducers: Identical to predicates RS80A, WS80A, HS70A systems. | The RS85 and predicates RS80A, WS80A, HS70A systems transducers are identical. |
| Materials: Evaluated and found to be safe for the intended use. | The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. |
| Acoustic Power Levels: Below applicable FDA limits. | The systems have acoustic power levels which are below the applicable FDA limits. |
| Capability: Similar measurements, digital image capturing, reviewing, and reporting to predicate RS80A systems. | The RS85 and predicate RS80A systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
| Safety and Performance Standards: Compliance with electrical, physical safety standards, and various IEC, ISO, and NEMA standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004). | The RS85 and predicate systems have been designed in compliance with approved electrical and physical safety standards. The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The RS85 and its applications comply with voluntary standards (listed in the document). |
| Quality Process: Conformance with 21 CFR 820 and ISO 13485. | The design, development and quality process of the manufacturer conforms with 21 CFR 820 and ISO 13485. |
Study Proving Acceptance Criteria:
The document clearly states:
"The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence."
This indicates that no dedicated clinical study was performed with the RS85 device to prove specific performance acceptance criteria in human patients. Instead, the FDA clearance for this device, a 510(k), is based on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for substantial equivalence are based on:
- Similar intended uses.
- Similar technological characteristics.
- Similar imaging capabilities and modes (with new features shown to be equivalent to features in existing cleared devices).
- Compliance with recognized performance standards (acoustic output, biocompatibility, electrical safety, etc.).
Therefore, the following points address the questions based on this underlying premise of substantial equivalence, rather than a new performance study:
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable, as no dedicated clinical test set from human subjects was used for a performance study. Non-clinical testing would have involved engineering samples and simulated environments.
- Data Provenance: Not applicable for a clinical test set. The data presented relates to engineering and bench testing, and comparisons to legally marketed predicate devices (K171048, K171070, K132274, K163691).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set requiring expert ground truth establishment for performance evaluation was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was conducted.
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
- No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The device is a diagnostic ultrasound system, and while it may incorporate advanced features, it is presented as substantially equivalent to existing non-AI predicate devices in its fundamental technology and clinical applications. There is no mention of AI assistance for human readers or any associated effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The RS85 is a diagnostic ultrasound system, not an AI-driven algorithm intended for standalone performance evaluation without human-in-the-loop. Its performance is assessed through its output in imaging modes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (acoustic output, biocompatibility, safety standards), the "ground truth" would be the specifications and requirements of the referenced standards (e.g., IEC 60601-1, NEMA UD 2-2004). For demonstrating substantial equivalence, the "ground truth" is established by the performance and safety profiles of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This document does not describe the development or training of an AI algorithm necessitating a training set. The device is a traditional ultrasound system.
9. How the ground truth for the training set was established
- Not applicable, as no training set for an AI algorithm is mentioned in this submission.
§ 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.