The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The Siemens ACUSON X150 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, or Harmonic Imaging and 3D Imaging on a Flat Panel Display.
This Siemens ACUSON X150™ Diagnostic Ultrasound System 510(k) submission (K121646) is a special 510(k) for an update to an existing device (K081121). Special 510(k)s by definition do not require clinical performance data for substantial equivalence and focus on verification and validation of design control processes. Therefore, the information provided primarily pertains to the system's intended use and compliance with technical standards rather than a study demonstrating clinical performance or acceptance criteria in the traditional sense of a clinical trial for a novel device or AI algorithm.
However, based on the provided text, I can infer the "acceptance criteria" as the claimed functionalities and indicated uses of the device, and the "reported device performance" as the assertion that these functionalities are present and the device complies with safety standards.
Here's the breakdown of the information you requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a special 510(k) for an updated ultrasound system, "acceptance criteria" here refers to the device's ability to perform its stated diagnostic imaging and fluid flow analysis functions across various clinical applications and modes of operation, and its compliance with relevant safety and performance standards. The "reported device performance" is the manufacturer's assertion that the device meets these criteria through verification and validation efforts, as is typical for a special 510(k).
| Acceptance Criteria (Stated Intended Use / Functionality) | Reported Device Performance (Manufacturer's Claim) |
|---|---|
| Multi-purpose diagnostic ultrasound system | Functions as described in B-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, combination modes, Harmonic Imaging, and 3D Imaging. |
| Supports various clinical applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular. | System is intended for and supports these applications, as detailed in the "Indications for Use" tables for the main system and each transducer. |
| Provides measurement of anatomical structures. | System provides analysis packages for clinical diagnosis. |
| Performs fluid flow analysis of the human body. | Supported across various clinical applications as indicated in the tables. |
| Complies with acoustic output standards (AIUM/NEMA UD-3, UD-2, IEC 1157). | Device has been evaluated and found to conform with these standards. |
| Complies with biocompatibility standards (ISO 10993-1). | Device has been evaluated and found to conform with this standard; patient contact materials are unchanged. |
| Complies with cleaning and disinfection effectiveness. | Device has been evaluated and found to conform with effectiveness. |
| Complies with thermal, electrical, electromagnetic, and mechanical safety standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, 93/42/EEC, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2). | Device has been evaluated and found to conform with these standards; electrical and mechanical safety are unchanged. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the sense of a dataset used to evaluate the performance of a novel algorithm or diagnostic metric. This submission is for an updated diagnostic ultrasound system and focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation. Therefore, there are no specific sample sizes for a 'test set' or data provenance mentioned in relation to real clinical data for performance evaluation in this 510(k) summary. The performance data section states, "The modifications to the Siemens ACUSON X150 Diagnostic Ultrasound System are verified and validated according to the company's design control process."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As explained above, there is no "test set" or ground truth established by experts for a clinical performance study in this 510(k) summary. The evaluation focuses on technical and safety compliance.
4. Adjudication Method for the Test Set
Not applicable. No "test set" that would require an adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states that the submission device is "substantially equivalent to the predicate with regard to both intended use and technological characteristics," implying that a full MRMC comparative effectiveness study was not deemed necessary for this special 510(k) submission. No effect size of human readers improving with AI vs. without AI assistance is mentioned because this is not an AI/CAD device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not a submission for an algorithm or AI device; it is for a diagnostic ultrasound system. Therefore, standalone algorithm performance is not relevant or evaluated here.
7. The Type of Ground Truth Used
Not applicable in the context of clinical study ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to established engineering specifications, safety standards, and performance characteristics as verified through design control processes. The "Indications for Use" tables define the intended clinical applications and operating modes, which are part of the device's functional "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no description of how ground truth for it would be established.
§ 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.