(29 days)
The ACUSON NX2TM ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.
Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."
The ACUSON NX2TM Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
This document is a 510(k) Summary for the Siemens ACUSON NX2™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics of a novel algorithm.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based feature. Instead, it demonstrates substantial equivalence to predicate devices for its various functionalities and intended uses.
The "perfomance" is indicated by the presence of features and functions ("√" for present, "-" for not present) compared to predicate devices. This implies that if a feature exists and is equivalent to a cleared predicate, it meets the "acceptance criteria" of substantial equivalence.
| Feature / Characteristic | Predicate Device ACUSON X700™ (K141846) | Predicate Device ACUSON NX3™ (K152469) | Submission Device ACUSON NX2™ | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|---|---|
| Indications for Use: | Match/Equivalent to Predicates | All listed indications match (√) | |||
| ■ Fetal Echo | √ | √ | √ | Present | Present (√) |
| ... (many other clinical applications) ... | √ | √ | √ | Present | Present (√) |
| Center Frequencies Supported (e.g., 2.0 MHz - 10.0 MHz): | √ | √ | √ | Present | Present (√) |
| Modes (e.g., B, M, PWD, CD, Power Doppler, Combined): | √ | √ | √ | Present | Present (√) |
| Features (e.g., SieClear, DTCE, TGO, DICOM, 3D Imaging, Syngo AHP): | √ | √ | √ | Present | Present (√) |
| Syngo AHP (Arterial Health Package) | √ | - | √ | Present (if on a predicate) | Present (√) |
Note: The document implicitly states that the device is "substantially equivalent with respect to safety and effectiveness" to the predicate devices if these features and characteristics are comparable.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Since the ACUSON NX2™ Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required."
This indicates that there was no specific "test set" of patient data used for clinical testing in this 510(k) submission. The evaluation relies on non-clinical tests and the established safety and effectiveness of the predicate devices. Therefore, there is no information on sample size, data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical test set was used for this specific submission, there is no information regarding experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical test set was used, there is no adjudication method described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No MRMC study was conducted or referenced as clinical data was not required for this submission. The effectiveness is established through substantial equivalence to predicate devices, which have already gone through regulatory clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe any standalone algorithm performance studies. The "ACUSON NX2™ Diagnostic Ultrasound System" is a complete hardware and software system, not a standalone algorithm. The "Arterial Health Package (AHP) software" mentioned is a component within the system; however, specific standalone performance data for this software is not presented. Its validation is stated as "referenced normative tables that have been validated and published in peer-reviewed studies" (Section C, Page 12).
7. The Type of Ground Truth Used
For the features like the Arterial Health Package (AHP) software, the ground truth for the normative tables it references is established through "peer-reviewed studies" (Section C, Page 12). However, for the overall system's substantial equivalence, the "ground truth" is effectively the established performance and safety of the predicate devices (ACUSON X700™ and ACUSON NX3™) that have already been cleared by the FDA.
8. The Sample Size for the Training Set
No training set is mentioned as clinical data was not required for this submission, and the basis for clearance is substantial equivalence.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned in the context of this 510(k) submission, the method for establishing its ground truth is not provided.
§ 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.