(26 days)
The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, 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: Ophthalmic, Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, 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 has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment (EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2); IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.
The Siemens Acuson X150 Ultrasound System is a diagnostic ultrasound system with accessories. The provided text, a 510(k) summary, indicates that the device's performance was verified and validated according to the company's design control process, asserting substantial equivalence to its predicate device, the Siemens Sonoline G40 ultrasound system. However, specific acceptance criteria and detailed clinical study results (like sensitivity, specificity, or accuracy) are not provided in the document.
The document primarily focuses on establishing substantial equivalence based on intended use and technological characteristics, and lists compliance with various safety and performance standards. It also details the clinical applications and modes of operation for the main system and individual transducers, indicating whether these are "new indications" (N) or "previously cleared by FDA" (P).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy thresholds) are mentioned in this 510(k) summary. The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets established safety and performance standards.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative performance metrics (e.g., sensitivity, specificity, accuracy). | "Verifited and validated according to the company's design control process." |
| Substantial equivalence to predicate device (Siemens Sonoline G40 ultrasound system) regarding intended use and technological characteristics. | Device found substantially equivalent by FDA. |
| Compliance with various safety and performance standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, ISO 10993-1). | Device is designed to meet these standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention any specific sample sizes (number of patients or images) used for testing the device's clinical performance. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention any details about experts used to establish ground truth, nor their number or qualifications.
4. Adjudication Method
The document does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study, nor does it provide any effect size for human readers improving with or without AI assistance. The device in question is an ultrasound system, not an AI-assisted diagnostic tool as understood in the typical context of MRMC studies for AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not mention a standalone study. The device is an ultrasound system, which inherently involves human operation.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established
The document does not mention a training set or how its ground truth might have been established.
Summary of Device Performance Study as Described in the 510(k) Summary:
The Siemens Acuson X150 Ultrasound System underwent verification and validation according to the company's design control process to demonstrate "substantial equivalence" to its predicate device, the Siemens Sonoline G40 ultrasound system. This substantial equivalence was affirmed by the FDA based on the device's intended use, technological characteristics, and compliance with a comprehensive list of recognized safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, AIUM/NEMA standards). The submission did not include specific clinical performance data (like sensitivity, specificity, or accuracy) derived from studies involving test sets, expert adjudication, or MRMC studies, as is often seen in submissions for AI/CADe devices. Instead, the focus was on technical and safety compliance and demonstrating that the device functions similarly to a legally marketed predicate.
§ 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.