(83 days)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, 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 2D 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, MV-Flow 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 may aid in making 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 provided text regarding the acceptance criteria and study information for the Samsung Medison Co., Ltd. RS85 Diagnostic Ultrasound System.
Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices. Therefore, it primarily compares the new device to predicates rather than presenting de novo acceptance criteria and extensive clinical trial data as might be found in a PMA (Premarket Approval) submission for a novel device or an AI breakthrough.
The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." This means that acceptance criteria for the device's performance in a clinical setting (e.g., diagnostic accuracy) are not detailed within this particular submission. The "acceptance criteria" presented below are inferred from the substantial equivalence claim and the comparison to predicate devices, focusing on technical and functional equivalence rather than clinical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" largely revolve around demonstrating the new device is functionally, technologically, and safely equivalent to existing cleared devices. The reported device performance is implicitly "meets or is similar to" the predicate devices.
| Feature/Criterion | Acceptance Criteria (Implied from Substantial Equivalence) | Reported Device Performance (Implicitly "Met") | Notes |
|---|---|---|---|
| Intended Use | Same as predicate devices | Same as predicate devices | "The Indications for use of the proposed device is same as primary predicate." |
| Clinical Applications | Same as predicate devices | Same as predicate devices | Listed applications are identical to primary predicate (K191115). New (N) or previously cleared (P) status for specific transducers indicates equivalence to other predicates or prior clearances. |
| Modes of Operation | Same as predicate devices | Same as predicate devices | All listed modes (B, M, PWD, CWD, Color Doppler, Combined, Other) are present and equivalent to primary predicate. |
| Scanhead Types | Same types and functionality as predicate devices | Same types and functionality as predicate devices | Linear Array, Curved Linear Array, Endocavity, Phased Array, Static Probes. |
| Scanhead Frequency | Within range of predicate devices (1.0 ~ 20.0 MHz) | 1.0 ~ 20.0 MHz | Identical to predicate devices. |
| Acoustic Output Display & FDA Limits | Conform to recognized standards (Track 3) and display MI/TI | - Display Feature for Higher Output- Track3 |
- MI Output Display
- TI Output Display | Identical to predicate devices. |
| Electrical Safety | Conform to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012 and IEC 60601-2-37 | RS85 evaluated per these standards. | Explicitly stated compliance. |
| Electromagnetic Compatibility | Conform to IEC60601-1-2: 2014 (4th Edition) | IEC60601-1-2: 2014 (4th Edition) | Explicitly stated compliance. |
| Biocompatibility | Conform to ISO 10993-1 Fourth edition 2009-10-15 | ISO 10993-1 Fourth edition 2009-10-15 | Explicitly stated compliance. |
| Reprocessing Medical Devices | Conform to FDA Guidance issued March 17, 2015, revised June 9, 2017 | Evaluated per guidance | Explicitly stated compliance. |
| Software/Firmware-driven Functionality | Evaluated using same criteria as predicate for image quality | Evaluated for migration into new system design. | "All migrated software functionality was evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality..." |
| Ultrasound Safety (Acoustic Output Measurement) | Conform to IEC60601-2-37:2007 + A1:2015 and NEMA UD 2-2004 (R2009) | IEC60601-2-37:2007 + A1:2015, NEMA UD 2-2004 (R2009) | Explicitly stated compliance. |
| System Characteristics (Channels, Monitor, Power) | Similar to predicate devices | 192 Transmit/Receive Channels, 23.8inch (new) / 23inch monitor, 256 gray shades, 100-240VAC, 1100VA, 50/60Hz | Comparison table shows equivalency or slight improvements (e.g., 23.8-inch monitor) that do not alter fundamental safety or effectiveness. |
| Specific Software Features | Functionally equivalent to corresponding features on predicate/reference devices | New features (EzHRI, QUS, PureVision), predicate features (ShadowHDR, BiometryAssist, IOTA-ADNEX) added, improved features (ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging, HQ-Vision, Setup&Preference), and name changes (Panoramic -> Panoramic+, MV-Index -> Vascularity Index, NeedleMate -> NeedleMate+) | This implies the new/changed features were tested to ensure they function as intended and do not negatively impact safety or effectiveness compared to predicates they are similar to. |
| Transducers | Functionally equivalent to previously cleared transducers | Various new (N) and previously cleared (P) transducers listed (e.g., LA2-14A, CA1-7S, PA1-5A, EV2-10A, EA2-11AR, EA2-11AV, EV2-10A) with specific indications. | Each transducer is compared to predicate transducers for substantial equivalence. "SE to predicates; refer to SE Analysis X" indicates supporting data. |
| Biopsy Guides | Compatible and functionally equivalent to predicate devices | BP-KIT-029 etc. (various models) | Same or functionally equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence."
Therefore:
- Sample size for test set: Not applicable (no clinical test set as part of this submission for substantial equivalence). The evaluation focused on engineering, software verification, and validation tests comparing the new system to already cleared devices.
- Data provenance: Not applicable for clinical data. The comparability data for components and technical specifications are likely derived from internal testing and validation processes by Samsung Medison (South Korea) against industry standards and predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given the statement that clinical studies were not required, there is no mention of external experts establishing a clinical "ground truth" for a test set in this submission. The "ground truth" for technical and functional validation would be against established engineering specifications, performance standards, and comparison with predicate device outputs. This would involve internal engineering and quality assurance teams.
4. Adjudication Method for the Test Set
Not applicable, as no external clinical test set requiring adjudication by experts is described in this 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
The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." Furthermore, while the device includes new software features like "EzHRI, QUS(TAI, TSI), PureVision" and improvements to "ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging", these are presented as enhancements or new capabilities whose safety and efficacy are demonstrated through technical equivalence to existing cleared features or algorithms, not through a comparative effectiveness study involving human readers and AI assistance. Therefore, no MRMC study or effect size for AI assistance is reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document doesn't provide specific details on standalone algorithm performance for features like EzHRI, QUS (TAI, TSI), PureVision, ElastoScan+, MV-Flow, S-Fusion, S-Shearwave Imaging, or BiometryAssist. The submission focuses on demonstrating that these software features (whether new or improved) are substantially equivalent to functions on predicate devices or previously cleared equivalents, or meet established performance criteria during internal testing. It implies that these features are integrated into the diagnostic ultrasound system, functioning as tools for a human operator, rather than performing as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" is primarily based on:
- Technical and functional specifications: Adherence to established engineering parameters, performance metrics, and compliance with national and international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2).
- Comparison to predicate devices: The functionality and safety characteristics of the RS85 (including its new and revised features) are demonstrated to be substantially equivalent to those of the predicate devices (RS85 K191115, HERA W10 K182595, HS50/HS60 K181336, and other reference devices like AIXPLORER K173021, Fibroscan K150949, AmCAD-US K162574). This means the performance of the predicate devices implicitly serves as a "ground truth" for what is acceptable.
There is no mention of pathology, expert consensus on clinical cases, or outcomes data as a "ground truth" within this 510(k) summary, as it explicitly states no clinical studies were required.
8. The Sample Size for the Training Set
Not applicable. As no clinical studies were performed, there is no mention of a clinical training set for any AI/software features. If any internal machine learning models are used within the software features (e.g., BiometryAssist, S-Detect), the details of their training data are not provided in this 510(k) summary. The submission focuses on the output of these features being equivalent to predicate devices or meeting internal specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no clinical training set is described in this document.
§ 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.