(31 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 B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode. Color Doppler Mode. Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
The provided 510(k) summary for the Siemens SC2000 Ultrasound System focuses on demonstrating substantial equivalence to previously cleared devices rather than outlining detailed acceptance criteria and a specific study proving device performance against those criteria. The submission is for a modification to an existing device (SC2000 Diagnostic Ultrasound System) and a new feature (Clarify VE).
Therefore, this document does not contain the specific information requested about acceptance criteria and a study demonstrating performance against them in the way a submission for a novel AI device might. Instead, it relies on demonstrating that the modified device continues to meet existing safety and performance standards, and that the new feature is substantially equivalent to a feature already cleared on another Siemens device.
However, I can extract information related to the performance data and the comparison to predicate devices, which implicitly serves as the "proof" of meeting acceptance criteria for a substantial equivalence determination.
Here's the breakdown of the requested information based on the provided text, along with notes about what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity targets) for a new algorithm or feature in the way a novel AI medical device submission would. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with established safety and performance standards and showing substantial equivalence to predicate devices.
The "reported device performance" is described qualitatively as meeting these standards and having similar technological characteristics and intended uses as cleared predicates.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety Compliance (e.g., UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 60601-1-1, IEC 60601-1-2, IEC 1157, ISO 10993-1) | The SC2000™ is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing. Final testing ensured the device meets all specifications and complies with applicable industry and safety standards listed (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 1157, ISO 10993-1). |
| Functional Equivalence - Intended Use (across various applications like Cardiac, Vascular, Superficial, Intraoperative, Transcranial) | The SC2000 ultrasound imaging system's intended uses are consistent with previous clearances (K072365, K102017, K113179, K123622, K130754) and traditional clinical practice. The detailed intended use descriptions for the overall system and specific transducers (e.g., 9L4, 6C1HD, V5M, 4V1c, 8V3, CW2, 4Z1c, AcuNav 8F/10F, AcuNav V, SoundStar 10F, 10V4, V7M) are listed as "P = Previously Cleared" indicating they meet previously established use cases. |
| Functional Equivalence - Technological Characteristics (e.g., imaging modes, features like Clarify VE, accessories, transducers, workflow acceleration, calculations packages) | The modified device has substantially equivalent indications for use and technological characteristics as the predicate devices ACUSON S2000 (K111674, 072786) and ACUSON SC2000 (K113179). The new feature, Clarify VE, is stated to be the same feature used on the S2000 (K072786) and described as "enhancing Bmode tissue resolution and reducing acoustic clutter... provides clearer vessel wall definition, improves tissue boundary detection and tissue contrast resolution, while preserving spatial resolution." The new 6C1HD transducer also has "no differences... from its use in S2000." The extensive comparison table (Section D) shows that almost all features were present in predicate devices ("X" under previous 510(k)s). |
| Quality System Compliance | The design and development process conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on substantial equivalence based on prior clearances and the nature of the modifications (Clarify VE being identical to a previously cleared feature on another system, and the new transducer being similar to existing ones). There is no mention of a specific clinical test set for this 510(k) submission.
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)
This information is not provided as there is no specific clinical test set described in this 510(k) summary for establishing ground truth for a novel AI algorithm. The device is an ultrasound system with enhanced imaging features, not an AI diagnostic algorithm requiring expert-labeled ground truth for evaluation in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided for the same reasons as point 3.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study would typically be performed for new AI-powered diagnostic aids, which is not the primary focus of this 510(k) submission (which is for a modification to an existing ultrasound system including a feature like Clarify VE, which enhances image quality rather than providing a direct diagnostic output that would assist human readers in a comparative effectiveness study).
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is not applicable and not mentioned. The device described is an ultrasound system, not a standalone algorithm. Clarify VE is an image enhancement feature integrated into the system, not a standalone algorithm output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided for a test set, as no specific clinical test set for new feature evaluation is detailed. The "performance data" section focuses on engineering verification and validation against safety and performance standards for the ultrasound system itself, not the clinical accuracy of a diagnostic output.
8. The sample size for the training set
This information is not provided. The document describes an ultrasound imaging system with a new image enhancement feature, not a machine learning model that would have a distinct training set.
9. How the ground truth for the training set was established
This information is not provided for the same reasons as point 8.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.