(62 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
Vascular Imaging Applications and Analysis
Superficial Imaging Applications
Intraoperative Imaging Applications
Transcranial Imaging Applications
The ACUSON SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system, with an on-screen display for thermal and mechanical indices, related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data, and display it in the following modes (The following modes below can be operated in combination or individually):
- B-Mode
- M-Mode .
- Pulsed (PWD) Doppler Mode .
- Continuous (CWD) Doppler Mode
- Color Doppler Mode .
- Amplitude Doppler Mode
- Color Velocity Imaging .
- 3D Imaging,
- 4D Imaging (3D imaging in real time) .
The provided document is a 510(k) premarket notification for the Siemens ACUSON SC2000™ Diagnostic Ultrasound System (K170315). It primarily details the device's indications for use and asserts substantial equivalence to a previously cleared predicate device (K162221). The document states that clinical data was NOT required for substantial equivalence, as the device is a Class II device and uses the same technology and operating principles as the predicate.
Therefore, the submission does not include any studies proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy in a clinical context. The review focuses on technical parameters, safety, and equivalence to a predicate.
However, based on the information provided, I can infer the implied acceptance criteria through compliance with standards and the "Substantial Equivalence Table" (page 22).
Here's a breakdown of the requested information based on the provided text, recognizing the absence of clinical performance studies:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance metrics are reported, the "acceptance criteria" here are implied by the safety and technical standards compliance and the "Same" performance claims against the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI/ANSI 60601-1 (Basic Safety & Essential Performance) | Conforms with standard |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Conforms with standard |
| Compliance with IEC 60601-2-37 (Ultrasonic Medical Diagnostic Monitoring) | Conforms with standard |
| Compliance with IEC 62366 (Application of Usability) | Conforms with standard |
| Compliance with IEC 62304 (Medical Device Software Life Cycle Process) | Conforms with standard |
| Compliance with NEMA UD-2 (Acoustic Output Measurement Standard) | Conforms with standard |
| Compliance with NEMA UD-3 (Real-Time Display of Thermal and Mechanical Acoustic Output Indices) | Conforms with standard |
| Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices) | Conforms with standard |
| Acoustic Output | Evaluated, complies with standards |
| Biocompatibility | Evaluated, complies with standards |
| Cleaning and Disinfection Effectiveness | Evaluated, complies with standards |
| Thermal Safety | Evaluated, complies with standards |
| Electromagnetic Safety | Evaluated, complies with standards |
| Mechanical Safety | Evaluated, complies with standards |
| Product Code(s) (IYO, IYN, ITX, OBJ) | Same as predicate (K162221) |
| Transducer Types (Matrix Array, Phased Array, Linear Array, Curved Array) | Same as predicate (K162221) |
| Modes of Operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, 3D, 4D) | Same as predicate (K162221) |
| Multi-Hertz multiple frequency imaging | Same as predicate (K162221) |
| Output display standard compliance | Same as predicate (K162221) |
| Dual screen | Same as predicate (K162221) |
| Acoustic clip capture | Same as predicate (K162221) |
| Cardiac Measurements and Calculations | Same as predicate (K162221) |
| DTI™ Doppler tissue imaging | Same as predicate (K162221) |
| Contrast pulse sequencing technology (CPS) | Same as predicate (K162221) |
| TEQ and NTEQ ultrasound technology for CPS | Same as predicate (K162221) |
| Vascular Imaging (Calculation and Measurements) | Same as predicate (K162221) |
| Spatial Compounding | Same as predicate (K162221) |
| Semi Auto Doppler Option (Trace Assist) | Same as predicate (K162221) |
| Transcranial Imaging | Same as predicate (K162221) |
| Wireless Network Connectivity | Same as predicate (K162221) |
| DICOM Compatibility | Same as predicate (K162221) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states that "clinical data is not required for substantial equivalence" (page 24). The evaluation was based on non-clinical tests (acoustic output, biocompatibility, cleaning, thermal, electromagnetic, and mechanical safety) and comparison to a predicate device.
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)
Not applicable. No clinical test set or expert-established ground truth is mentioned. The assessment was based on engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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/CADe device, and no MRMC study or AI assistance is mentioned.
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 algorithm, and no standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the determination of substantial equivalence, the "ground truth" was compliance with established medical device safety and performance standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993-1) and the technical specifications of the predicate device (K162221).
8. The sample size for the training set
Not applicable. No algorithms requiring a training set are discussed in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. No algorithms requiring a training set are discussed.
§ 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.