(99 days)
The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.
The WS80A 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, M mode, Color Doppler imaging, Power Dopler 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 WS80A 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 WS80A 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 WS80A Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive study as one might see for novel AI/ML medical devices.
Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria (like performance metrics for an AI algorithm), nor does it provide a table of acceptance criteria with reported performance data in the context of an AI/ML-driven device.
Specifically, the document states: "The subject of this premarket submission, WS80A, did not require clinical studies to support substantial equivalence." This means there wasn't a clinical study to assess "device performance" in terms of algorithm accuracy, sensitivity, specificity, etc., as would be required for an AI/ML product.
However, I can extract the relevant information from the document regarding the device and its safety/effectiveness claims based on the provided text, while making it clear that it's for a traditional ultrasound system and not an AI/ML device in the sense of the detailed study requested.
Here's a breakdown based on the categories you provided, with explanations for why some information is absent:
Device: WS80A Diagnostic Ultrasound System
Type of Premarket Submission: 510(k) Premarket Notification - Traditional
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC) or reported performance data for an AI/ML model, because the WS80A is a traditional diagnostic ultrasound system. Its "performance" is demonstrated through its substantial equivalence to predicate devices, ensuring it meets safety and effectiveness standards for ultrasonic imaging.
The document discusses features and modes of operation:
| Feature/Mode | Description / Status |
|---|---|
| Imaging Modes | B mode, M 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 combinations. |
| Capabilities | Ability to measure anatomical structures, analysis packages for diagnosis, real-time acoustic output display (Mechanical Index and Thermal Index). |
| E-Cervix | Substantially equivalent to Hitachi Noblus (K142368). |
| E-Strain, S-Detect for Breast, S-Detect for Thyroid | Substantially equivalent to Samsung Medison RS80A (K171048). |
| Acoustic Power Levels | Below applicable FDA limits. |
| Measurements, Digital Images, Review, Reporting | Same capability as predicate devices. |
| Electrical/Physical Safety | Designed in compliance with approved electrical and physical safety standards. |
2. Sample size used for the test set and the data provenance
Not applicable for this 510(k) submission. No "test set" in the context of validating an AI/ML algorithm's performance on clinical data was used or described. The validation is based on technological comparison and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for an AI/ML algorithm test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a traditional ultrasound system, the "ground truth" for its operation often refers to physical and engineering principles, and its ability to accurately render anatomical structures and fluid flow. Substantial equivalence relies on the device performing equivalently to a legally marketed predicate, meaning it can acquire and display information that medical professionals interpret to reach a diagnosis.
8. The sample size for the training set
Not applicable. No AI/ML model training is described.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Acceptance Approach in K173513:
The Samsung Medison WS80A Diagnostic Ultrasound System (K173513) gained FDA clearance through a 510(k) Traditional pathway. This means the approval was based on demonstrating substantial equivalence to already legally marketed predicate devices, specifically:
- WS80A Diagnostic Ultrasound System (K171070)
- RS80A Diagnostic Ultrasound System (K171048)
- Noblus™ Ultrasound Diagnostic System (K142368)
The manufacturer argues, and the FDA concurs, that the device is substantially equivalent in terms of:
- Intended use: Diagnostic ultrasound imaging and fluid analysis of the human body across various clinical applications (Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel).
- Imaging capabilities: It shares core imaging modes (B, M, Doppler, 3D/4D, Elastoscan, etc.) with its predicates. Specific features like E-Cervix, E-Strain, and S-Detect are stated to be substantially equivalent to those found in the predicate devices.
- Technological characteristics: Employs the "same fundamental scientific technology."
- Safety and Effectiveness:
- No new hazards were identified.
- Acoustic output and biocompatibility were evaluated.
- Cleaning & disinfection effectiveness, electromagnetic compatibility, electrical, and mechanical safety were assessed and found compliant with applicable medical device safety standards.
- The system includes real-time acoustic output display with Mechanical Index and Thermal Index.
- The design, development, and quality process conform to 21 CFR 820 and ISO 13485.
Crucially, no new clinical studies were required for this submission because substantial equivalence was established through non-clinical testing and comparison to predicates. This indicates that the device's mechanism of action and expected performance were well-understood and similar to existing cleared devices, making detailed clinical performance studies unnecessary for this specific type of 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.