(40 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intrcperative Neurological, 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 themical indices related to potential bio-effect mechanisms. Its function is to acquire primary of Secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Dopler Mode, a combination Continuous (CW) Doppler Mode, Color Dopen Mode, Ampling on a France, Nissalay of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000™Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat P available off-line workstation (SC2000WP).
Here's an analysis of the provided 510(k) summary regarding the Acuson SC2000™ Diagnostic Ultrasound System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics in the way a clinical trial for a new therapeutic device might. The "performance data" section in this type of submission generally refers to engineering verification and validation against internal specifications and relevant safety standards, rather than direct clinical performance in terms of diagnostic accuracy against a ground truth in a clinical setting.
Therefore, the answers below will reflect the information available in this type of regulatory document. Many of the requested details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, effect size, and training set information) are explicitly not present in a standard 510(k) premarket notification for an ultrasound system, as this is a device modification submission focusing on safety and technological equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily based on established safety and performance standards for diagnostic ultrasound systems, and the "reported device performance" is the device's demonstrated compliance with these standards and verification of its specifications.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| UL 60601-1 (Safety Requirements for Medical Equipment) | Compliant |
| IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards) | Compliant |
| CSA C22.2 No. 601-1 (Safety Requirements for Medical Equipment) | Compliant |
| AIUM/NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices) | Compliant |
| AIUM/NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound) | Compliant |
| IEC 60601-1 (Safety and EMC Requirements for Medical Equipment) | Compliant |
| IEC 60601-1-1 | Compliant |
| IEC 60601-1-2 | Compliant |
| IEC 1157 (Declaration of Acoustic Power) | Compliant |
| ISO 10993-1 (Biocompatibility) | Compliant |
| Meeting company's design control process and specifications | Verified and validated through extensive safety and performance testing |
| Substantial equivalence to predicate devices (K072365 and K102017) in intended use and technological characteristics | FDA determined substantially equivalent based on the submission |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy). The performance data cited refers to engineering and safety testing. Therefore, there is no information provided regarding sample size for a clinical test set or data provenance (e.g., country of origin, retrospective/prospective clinical data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. As stated above, this submission focuses on technical safety and performance validation against standards, not a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No clinical test set or adjudication method is mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. The document does not mention any MRMC comparative effectiveness study, nor does it provide information on a human readers' improvement with or without AI assistance. This type of study is not common for 510(k) submissions of basic ultrasound system modifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. The SC2000™ is a diagnostic ultrasound system, an imaging device operated by a human. It is not an AI algorithm intended for standalone diagnostic performance. The document describes the system's ability to acquire and display ultrasound data, and its "calculation packages" provide information to the clinician for diagnosis, implying human interpretation is always in the loop.
7. The Type of Ground Truth Used
For the safety and performance testing described, the "ground truth" is defined by the technical specifications for the device and the objective criteria outlined in the various international and national safety and performance standards (e.g., acoustic output measurements, electrical safety limits, biocompatibility standards). This is engineering and regulatory compliance ground truth, not clinical ground truth (like pathology results or patient outcomes) for diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable/Not provided. This submission describes an ultrasound imaging system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided. As there is no mention of a machine learning model or training set, the establishment of ground truth for such a set is not relevant to this 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.