(8 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, and Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.
The SA-9900PLUS scanner 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-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS 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 SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Thirteen different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA-9900PLUS uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided text is a 510(k) Premarket Notification for the SA-9900PLUS Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8000 - K013627) rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
For a diagnostic ultrasound system like the SA-9900PLUS, acceptance criteria typically involve demonstrating that the new device performs as intended and is as safe and effective as the predicate device. This is primarily achieved by showing that its technological characteristics and intended uses are the same or very similar to the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the "study" demonstrating criteria fulfillment is primarily a comparison of specifications and intended uses against the predicate devices. The document does not contain information about a traditional clinical study with a test set, ground truth established by experts, sample sizes for training or testing, adjudication methods, or MRMC studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) context) | Reported Device Performance (SA-9900PLUS) |
|---|---|
| Intended Use Equivalence: | The SA-9900PLUS has the same clinical applications as predicate devices SA9900 (K002185) and SA8000 (K013627), including fetal, abdominal, pediatric, small organ, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. Some transducers introduce new indications (marked 'N' in the tables) but these are still within the general scope of diagnostic ultrasound. |
| Technological Characteristics Equivalence: | Uses digital beamforming technology, supports various transducer types (Linear, Convex, Phased Array, Static probes) from 1.0 MHz to 20.0 MHz, and offers B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler, and Power Doppler modes, or combinations thereof. These are presented as identical to predicate devices. |
| Performance (Imaging Capabilities & Measurement Functions): | Provides high resolution, high penetration performance, and various measurement functions (distances, areas, circumferences, volumes, EDD calculations, cardiac and vascular analysis). Cine function (up to 256 images), real-time zoom, and DICOM 3.0 compatibility are also supported. The functionalities for measurement and imaging modes are consistent with general diagnostic ultrasound systems. |
| Acoustic Output Limits: | Maximum ISPTA: 720 mW/cm², Maximum MI: 1.9. These limits are stated to be "the same as predicate Track 3 devices." |
| Electromechanical Safety Standards Compliance: | Meets EN 60601-1 (IEC 601-1), UL 2601-1, CAN/CSA C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2 (IEC 60601-1-2), and is compliant with the European Medical Device Directive. |
| Biocompatibility of Patient Contact Materials: | "Transducer patient contact materials are biocompatible." |
2. Sample size used for the test set and the data provenance:
- The document does not describe a specific "test set" or a formal clinical study with patient data to evaluate the device's performance against predefined acceptance criteria in the way a new, novel device might.
- The data provenance is implicitly from the specifications and performance of the predicate devices (SA 9900 - K002185 and SA8000 - K013627), which would have been cleared based on their own performance data. The SA-9900PLUS is stated to operate "identical to the predicate devices."
- This is a retrospective comparison against existing device specifications rather than a prospective study on new data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with ground truth established by experts in this 510(k) summary. The submission relies on substantial equivalence to predicate devices.
4. Adjudication method for the test set:
- Not applicable. No test set or expert adjudication is described.
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 study mentioned. This device predates widespread AI integration in diagnostic ultrasound and is being cleared based on substantial equivalence, not a comparative effectiveness study involving human readers and AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a diagnostic ultrasound system, not an AI algorithm, and therefore a "standalone" performance study in the context of AI is not relevant. The device requires a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No explicit ground truth is mentioned as part of this submission for the SA-9900PLUS itself. The "ground truth" for showing equivalence relies on the established safety and effectiveness of the predicate ultrasound systems.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that undergoes a training phase as described in the context of modern AI devices.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device with a training set.
§ 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.