(24 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, Intraoperative 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 to the clinician 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 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 text describes a 510(k) premarket notification for the Siemens Acuson SC2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K132654) due to modifications. The document does not describe an AI or algorithm-based device or a study involving an algorithm's performance.
Therefore, many of the requested categories (acceptance criteria for an algorithm, AI performance, MRMC study, training set information, ground truth methods for an algorithm) cannot be extracted or are not applicable to the provided content.
The information primarily concerns the intended uses and technical characteristics of an ultrasound system and its transducers, demonstrating that new components (like the Z6Ms transducer) and updated catheters still fall within the scope of the predicate device.
However, based on the general principles of medical device 510(k) submissions, I can infer what "acceptance criteria" and "study" would generally mean in this context for a non-AI ultrasound device, and extract relevant performance information.
1. A table of acceptance criteria and the reported device performance
For a standard diagnostic ultrasound system like the Acuson SC2000™, the "acceptance criteria" are intrinsically tied to meeting established safety and performance standards for ultrasound devices, as well as demonstrating that the device performs as intended for its specified clinical applications. The "reported device performance" refers to the results of testing confirming compliance with these standards and the functionality for the intended uses.
| Acceptance Criteria Category | Specific Criteria (Inferred from documentation) | Reported Device Performance (Inferred from documentation) |
|---|---|---|
| Safety Standards Compliance | Device must comply with all applicable safety standards (electrical, mechanical, acoustic output, biocompatibility). | The Acuson SC2000™ has been designed to meet and has been subjected to extensive safety and performance testing ensuring compliance with: |
- AIUM/NEMA UD-3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- AIUM/NEMA UD-2 (Acoustic Output Measurement Standard)
- IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)
- IEC 62304 (Medical device software – Software life cycle processes)
- IEC 62366 (Medical devices – Application of usability engineering to medical devices)
- ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) |
| Intended Use Functionality | The system and its transducers must reliably perform imaging and measurement functions for specified clinical applications (e.g., Cardiac, Pediatric, Fetal, Abdominal, Vascular, Intraoperative, Transcranial, Musculoskeletal). | The system creates 2D(B), 3D, M-Mode, Color Doppler, Color Power Doppler, Pulsed Wave Doppler, and Continuous Wave Doppler images/data to obtain images and blood flow velocity, enabling evaluation of pathology and provision of measurement/calculation packages for diagnostic purposes across all stated applications. The system supports various transducers (e.g., V5Ms, 4Z1c, Z6Ms, CW2, 4V1c, 6CIHD, 8V3, 9L4, 10V4, AcuNav 8F/10F, AcuNav V 10F, SoundStar 10F) for these applications. |
| Technological Characteristics | Key characteristics (e.g., array type, dimensional imaging, mechanical controls, modes of operation, multi-Hertz imaging, output display, dual screen, acoustic clip capture, Cardiac/Vascular measurements, DTI, Contrast Imaging, Connectivity via Wireless/DICOM) must be maintained or be substantially equivalent to the predicate device. | The system maintains similarity in product codes, transducer types, modes of operation, multi-Hertz multiple frequency imaging, output display standard compliance, dual screen functionality, acoustic clip capture, Cardiac/Vascular Measurements and Calculations, DTI™, Contrast Pulse Sequencing Technology (CPS), TEQ and NTEQ ultrasound technology, Spatial Compounding, Semi Auto Doppler Option (Trace Assist), Transcranial Imaging, and connectivity features (Wireless Network Connectivity, DICOM Compatibility) as compared to the predicate K132654. The new Z6Ms transducer's array type, dimensional imaging, and mechanical controls are deemed substantially equivalent to existing transducers (4Z1c and V5Ms). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not directly specify a "test set" in the context of an algorithm or diagnostic performance study with patient data. For a non-AI ultrasound system like this, compliance is typically demonstrated through:
- Engineering verification and validation (testing of components, software, and integrated system against specifications).
- Bench testing for acoustic output and electrical safety.
- Potentially, limited clinical evaluations or comparisons to the predicate device to confirm imaging quality and diagnostic utility for the new or modified components.
The submission states, "Final testing of the SC2000™ included various safety and performance testing designed to ensure the device meets all of its specifications." However, no specific sample size (e.g., number of patients or images) for a clinical "test set" is provided, nor is the data provenance explicitly stated. This information is typically proprietary to the manufacturer and not fully disclosed in the 510(k) summary, especially for devices establishing substantial equivalence through technical modifications rather than new clinical claims requiring large-scale trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Again, this document does not describe an AI or algorithm-based device that would require a ground truth established by experts for a test set. For a diagnostic ultrasound system, "ground truth" for demonstrating diagnostic utility would typically involve comparison to other established diagnostic modalities or expert clinical interpretation. However, the document does not provide details on such a study for "ground truth" establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no external "test set" requiring expert adjudication is described for an AI algorithm.
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, as the document concerns a medical imaging device (ultrasound system and transducers), not an AI algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable, as the device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated for the purpose of validating the diagnostic accuracy of the ultrasound system in a formal study. For an ultrasound device, diagnostic accuracy is often evaluated relative to established clinical standards, other imaging modalities, or direct observation (e.g., during surgery or pathology). However, the submission focuses on demonstrating safety, technical performance, and substantial equivalence to a predicate device, rather than providing details of a de novo diagnostic accuracy trial with a specific "ground truth."
8. The sample size for the training set
Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm that undergoes "training."
9. How the ground truth for the training set was established
Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm.
§ 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.