(29 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/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) 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 text describes a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through new clinical trials. Therefore, the document does not contain acceptance criteria, a study proving device meeting acceptance criteria, or information on AI/standalone performance.
Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not applicable to a 510(k) submission for this device:
Analysis of Acceptance Criteria and Study for RS80A Diagnostic Ultrasound System (K162094)
The provided document is a 510(k) Premarket Notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to establish new clinical effectiveness or safety based on acceptance criteria or a dedicated clinical performance study with human readers and AI assistance in the way a PMA (Premarket Approval) might require for novel devices.
Therefore, many of the requested details regarding acceptance criteria, performance metrics, and clinical study designs (especially those involving AI-assisted human readers or standalone AI performance) are not applicable or not present in this type of submission for this particular device.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable in a 510(k) for this device.
A 510(k) submission for an ultrasound system like the RS80A typically focuses on demonstrating that its technological characteristics, intended use, and safety/EMC performance are equivalent to predicate devices. It does not typically define specific clinical performance acceptance criteria (e.g., sensitivity, specificity for a particular pathology) that the device must meet, nor does it report device performance against such criteria. The "performance" demonstrated is primarily technical capability and compliance with safety standards.
The document states: "The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards." This is the primary "performance" being demonstrated for substantial equivalence in a 510(k).
Technological Characteristics Comparison Table (from pages 32-33):
This table compares features of the RS80A (V3.00) to its predicate devices, demonstrating equivalence in functionality, scanhead types, frequency ranges, and modes of operation. This acts as the "performance data" in the context of substantial equivalence, showing that the new device offers comparable features and safety.
| Feature / Characteristics | RS80A (V3.00) (Subject Device) | RS80A (K151663) (Predicate) | WS80A (K153529) (Predicate) | HM70A (K130803) (Predicate) | LOGIQ E9 (K123564) (Predicate) | Voluson E10 (K131267) (Predicate) |
|---|---|---|---|---|---|---|
| Indication for Use | ||||||
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ |
| - Gynecology | √ | √ | √ | √ | √ | √ |
| - Intraoperative | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ |
| - Trans-esoph. (non-Cardiac) | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal (Conventional) | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal (Superficial) | √ | √ | √ | √ | √ | √ |
| - Urology | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ |
| - Trans-esophageal (Cardiac) | √ | √ | √ | √ | √ | |
| - Peripheral vessel | √ | √ | √ | √ | √ | √ |
| Scanhead Types | ||||||
| - Linear Array | √ | √ | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ | √ | √ |
| - Endocavity | √ | √ | √ | √ | √ | √ |
| - Phased Array | √ | √ | √ | √ | √ | √ |
| - Static Probes | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | ||||||
| 1.0 ~ 20.0 MHz | √ | √ | √ | √ | √ | √ |
| Modes of Operation | ||||||
| - B-mode | √ | √ | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ | √ | √ | √ |
| - Continuous wave (CW) Doppler | √ | √ | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ | √ | √ |
| - Power Amplitude Doppler | √ | √ | √ | √ | √ | √ |
| - Tissue Harmonic Imaging | √ | √ | √ | √ | √ | √ |
| - 3D/4D imaging mode | √ | √ | √ | √ | √ | √ |
| - Combined modes | √ | √ | √ | √ | √ | √ |
| Safety & EMC Compliance | ||||||
| - IEC 60601-1 / UL 60601-1 | √ | √ | √ | √ | √ | |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ | √ |
| - Acoustic Output Display Std (Track 3) | √ | √ | √ | √ | √ | √ |
| - Patient Contact Materials (ISO 10993-1) | √ | √ | √ | √ | √ | √ |
| Functionality | ||||||
| - Q Scan | √ | √ | √ | √ | ||
| - ClearVision | √ | √ | √ | √ | ||
| - MultiVision | √ | √ | √ | √ | ||
| - Panoramic | √ | √ | √ | √ | ||
| - Needle Mate | √ | √ | √ | √ | ||
| - Auto IMT+ | √ | √ | √ | √ | ||
| - Strain+ | √ | √ | √ | |||
| - Stress Echo | √ | √ | √ | |||
| - Elastoscan | √ | √ | √ | √ | √ | √ |
| - E-Thyroid | √ | √ | ||||
| - E-Breast | √ | √ | ||||
| - S-Shearwave | √ | √ | √ | |||
| - S-Detect | √(1) | √ | √ | √ | √ | |
| - S-Fusion | √ | √ | ||||
| - Clear Track | √ | √ | √ | |||
| - Virtual Track | √ | √ | √ | |||
| - ADVR | √ | √ | √ | √ | - | |
| - 3D Imaging (Volume Data Acquisition) | √ | √ | √ | √ | √ | √ |
| - 3D Imaging presentation (3D Cine/4D Cine) | √ | √ | √ | √ | ||
| - 3D Rendering MPR | √ | √ | √ | √ | ||
| - 3D XI MSV/Oblique View | √ | √ | √ | √ | ||
| - 3D MXI Volume Slice/Mirror View | √ | √ | √ | |||
| - Volume CT | √ | √ | √ | |||
| - 3D MagiCut | √ | √ | √ | √ | ||
| - Volume Calculation (VOCAL, XI VOCAL) | √ | √ | √ | √ | ||
| - XI STIC | √ | √ | √ | √ | ||
| - HDVI | √ | √ | √ | √ | ||
| - Realistic Vue | √ | √ | √ | |||
| - Natural Vue | √ | √ | ||||
| - HQ Vision | √ |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable for this specific 510(k) submission.
The document states "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used for an effectiveness study in the usual sense. The testing performed was primarily non-clinical (bench tests) for safety and performance against standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable.
As no clinical effectiveness study was required, there was no ground truth for a test set established by experts in the context of clinical performance (e.g., for diagnostic accuracy).
4. Adjudication Method for the Test Set
Not Applicable.
Since no test set with expert ground truth was established for a clinical effectiveness study, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. without AI Assistance
Not Applicable.
The document does not mention any AI functionality in the context of diagnostic interpretation or a human-in-the-loop study comparing human readers with and without AI assistance. The features listed are image enhancement, processing, and visualization capabilities (e.g., HQ Vision, 3D imaging, ElastoScan, S-Fusion, S-Shearwave, S-Detect). While "S-Detect" might imply some level of automated detection, the submission does not describe it as an AI-driven diagnostic aid requiring an MRMC study or reporting an effect size on human readers. The purpose of this 510(k) filing is to demonstrate substantial equivalence, not superior effectiveness through such comparative studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable.
There is no mention of a standalone algorithm performance evaluation in the provided document. The device is a diagnostic ultrasound system intended for use by a "competent health care professional."
7. The Type of Ground Truth Used
Not Applicable (for clinical effectiveness).
As no clinical effectiveness study requiring ground truth (e.g., pathology, outcomes data) was conducted for this 510(k) submission, this information is not available. The "truth" evaluated was compliance with safety standards and equivalence to predicate device specifications.
8. The Sample Size for the Training Set
Not Applicable.
Since this is not an AI/machine learning device undergoing a clinical performance study that would typically involve a "training set" for an algorithm to learn, this information is not relevant to this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there was no training set for an algorithm, the method for establishing its ground truth is not relevant or provided.
Summary of what the K162094 510(k) demonstrates:
The 510(k) for the RS80A Diagnostic Ultrasound System (K162094) demonstrates substantial equivalence to previously cleared predicate devices (RS80A Diagnostic Ultrasound System (K151663), WS80A Diagnostic Ultrasound System (K153529), HM70A Diagnostic Ultrasound System (K153408), LOGIQ E9 Diagnostic Ultrasound System (K142160), Voluson E10 Diagnostic Ultrasound System (K131267), AmCAD-UT (K122536), QLAB (K121223)). This equivalence is based on:
- Identical Intended Uses: The RS80A and its transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications.
- Similar Technological Characteristics: The device utilizes standard ultrasound imaging modes (B-mode, M-mode, Doppler modes, harmonic imaging, 3D/4D imaging) and offers advanced features (e.g., Elastoscan, S-Detect, S-Fusion, HQ Vision) similar to or improved upon those in the predicate devices.
- Compliance with Recognized Standards: The device has been evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to international and national medical device safety standards (e.g., 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 document explicitly states that clinical studies were not required to support substantial equivalence for this submission because it falls under the scope of demonstrating technical and safety equivalence to existing devices.
§ 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.