(29 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/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric 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 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 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.
This looks like a 510(k) summary for a diagnostic ultrasound system (WS80A) and its transducers. The document emphasizes that the device is substantially equivalent to previously cleared predicate devices and relies on non-clinical tests (bench testing, safety standards compliance) rather than a clinical study to demonstrate this.
Here’s a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a dedicated performance study with specific metrics like sensitivity, specificity, or accuracy. Instead, it demonstrates performance by asserting substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with recognized safety standards.
The closest equivalent to "acceptance criteria" is the comprehensive list of features and clinical applications provided for the WS80A and its various transducers, showing that they function similarly to the predicate devices. The "reported device performance" is implicitly that the WS80A performs safely and effectively in all its indicated modes and applications, matching or being equivalent to the listed predicate devices.
Here's a table based on the provided "Technological Characteristics Comparison Table" from the document (page 22), focusing on the parity claimed with existing devices.
| Feature / Characteristic | Acceptance Criteria (Implied) - Match/Equivalence to Predicates | Reported Device Performance (WS80A) |
|---|---|---|
| Indication for Use | Must cover similar clinical applications as predicate devices. | All listed applications (Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel) are present ("√"). |
| Scanhead Types | Must include similar scanhead types as predicate devices. | Linear Array, Curved Linear Array, Endocavity, Phased Array are all present ("√"). |
| Scanhead Frequency | Must operate within similar frequency ranges as predicate devices. | 1.0 ~ 20.0 MHz range is present ("√"). |
| Modes of Operation | Must include similar operational modes as predicate devices. | 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 are all present ("√"). |
| Safety & EMC Compliance | Must comply with recognized safety and EMC standards. | • UL 60601-1: √ |
| • IEC 60601-2-37: √ | ||
| • IEC 60601-1-2: √ | ||
| Acoustic Output Display Standard | Must comply with NEMA UD-3. | Track 3 display is present ("√"). |
| Patient Contact Materials | Must be tested to ISO 10993-1. | Tested to ISO 10993-1 ("√"). |
| Functionality (Software/Hardware Features) | Must have equivalent functionality to predicate devices, including specific "5D" features like 5D CNS, 5D Follicle, 5D Heart. | All listed functionalities (Quick Scan, MultiVision (formerly Spatial Compound Imaging), ClearVision (formerly SMDR), Auto IMT+, Elastoscan, Panoramic, 3D Imaging, 3D Cine/4D Cine, 5D Cine, 3D Rendering (MPR), 3D XI (MSV), 3D MXI (Volume Slice, Mirror View), XI Volume CT, 3D MagiCut, Volume Calculation (VOCAL, XI VOCAL), XI STIC, HDVI, Realistic Vue (formerly FRV), Volume NT/IT, 5D NT, 2D NT, 5D LB, MPI, 5D CNS, 5D Follicle, 5D Heart) are present or equivalent to predicate features ("√" with corresponding notes for name changes or predicate for '5D' features). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Not applicable. The subject of this submission. WS80A, did not require clinical studies to support substantial equivalence." Therefore, there is no "test set" in the context of clinical validation, and no information on sample size or data provenance from a performance study. The evaluation primarily relied on non-clinical (bench) tests and comparison to predicate devices against recognized standards.
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)
Since no clinical study was conducted, there are no experts establishing ground truth for a test set. This information is not applicable and not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical study was performed, there was no test set requiring an adjudication method. This information is not applicable and not provided.
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 does not describe an MRMC comparative effectiveness study. It states that clinical studies were not required. The "5D" features (5D CNS, 5D Follicle, 5D Heart) are described as features that "assist with diagnosis," implying a potential benefit to users, but no study is presented to quantify this improvement or effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a diagnostic ultrasound system and its transducers, which are inherently "human-in-the-loop" devices used by healthcare professionals. While it does mention "S/W Features" like "5D CNS," "5D Follicle," and "5D Heart" that "assist with diagnosis," it does not present a standalone algorithm-only performance study. These features are integrated into the system for use by an operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (acoustic output, biocompatibility, electrical, electromagnetic, mechanical safety), the "ground truth" would be the specifications and requirements of the referenced international and national standards (e.g., IEC 60601-1, NEMA UD-2, ISO 10993-1). The device's performance was measured against these standards. For the functionality comparison, the "ground truth" is the established functionality and performance of the predicate devices.
8. The sample size for the training set
The document does not describe any machine learning or AI model development that would typically involve a "training set." The "5D" features are mentioned, but no details regarding their development, training data, or sample sizes are provided. Given the nature of a 510(k) for an ultrasound system, the focus is on hardware and software equivalence and safety rather than novel AI algorithm validation.
9. How the ground truth for the training set was established
Since no training set is described, the method for establishing its ground truth is not provided.
§ 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.