(35 days)
The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, 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 and published 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 NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their functions are 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 imaqing on a Flat Panel Display.
This is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML device. Therefore, the typical acceptance criteria and study components related to software performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or provided in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)) by comparing intended use, technological characteristics, and compliance with safety standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device with specific performance metrics like sensitivity/specificity, the 'acceptance criteria' are primarily related to safety, operational modes, and clinical applications, demonstrating equivalence to the predicate device. The performance is implied by its equivalence to a previously cleared device and compliance with established safety and performance standards.
| Acceptance Criteria (Implied from Substantial Equivalence to K172374) | Reported Device Performance (Submission Device: ACUSON NX2/NX2 Elite) |
|---|---|
| Intended Use Equivalence: Same clinical applications as predicate: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel), Musculoskeletal. | Matches predicate's intended uses across all listed clinical applications. |
| Technological Characteristics Equivalence: Same operational modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Combined modes, THI, AMM, etc.) and features as predicate. | Matches predicate's operational modes and most features, including new transducer types (10MC3, C8F3, CW2, CW5) also matching predicate's capabilities or having equivalent performance. New indications for the 10MC3 transducer are clearly marked. |
| Safety and Performance Standards Compliance: Conformance to recognized standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety. | Verified to conform to applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, AIUM/NEMA UD-3, IEC 62359, IEC 60601-1-2, ISO 10993-1). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a diagnostic ultrasound system, not a software algorithm requiring a test set of patient data to evaluate performance metrics. The evaluation focuses on engineering, safety, and functional equivalence.
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)
Not applicable. Ground truth for diagnostic performance evaluation is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication of ground truth is mentioned.
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
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It's a diagnostic ultrasound system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Clinical performance data is not provided as part of this 510(k) submission, as it relies on substantial equivalence to an existing device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.