Search Results

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 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

The provided text is a 510(k) premarket notification for the ACUSON X150 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses common for novel device performance claims.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets them, sample sizes (test or training), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or how ground truth was established for training data.

The document states:

• "The ACUSON X150 modifications are verified and validated according to the company's design control process." (Section 12, E. Performance Data) This is a general statement about their internal quality system processes rather than a summary of specific performance study results.
• The FDA's letter (K081121) confirms substantial equivalence to a predicate device, which inherently means that its performance is considered comparable and acceptable based on existing standards and the predicate's established safety and effectiveness.

The tables provided describe the intended use and available modes of operation for various transducers with the ACUSON X150 system, indicating which applications (e.g., Fetal, Abdominal, Cardiac) and modes (e.g., B-mode, M-mode, Color Doppler) were "previously cleared by K070576" (the predicate device) or are "new indications" (though for this submission, most are "P" indicating previously cleared). This is a functional description, not a performance evaluation against specific metrics.

Ask a specific question about this device

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.

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.

Ask a specific question about this device