For ACUSON NX3
The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology 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.
For ACUSON NX3 Elite
ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology 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 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 Siemens ACUSON NX3 Elite™ and ACUSON NX3™ 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. Its function is to acquire harmonic ultrasound echo data and display it in B-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) premarket notification for the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems by Siemens Medical Solutions USA, Inc. As such, it primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and performance studies in the way you might find for novel AI/ML devices.
Therefore, the information you requested regarding acceptance criteria and study details to prove the device meets them is largely based on demonstrating equivalence to existing, legally marketed ultrasound systems, and general safety and performance standards, rather than specific performance metrics for a new AI feature. The document explicitly states: "Since the ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required." This means there won't be a study demonstrating the device meets specific performance criteria in the sense of a new technology needing to prove its efficacy.
However, I can extract the information related to the device's characteristics and the basis for its clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices (ACUSON X700™ Diagnostic Ultrasound System (K141846) and ACUSON X300™ Diagnostic Ultrasound System (K121699)) and adherence to recognized safety standards. The "reported device performance" is essentially that it functions similarly to the predicate devices across a range of applications and modes.
| Feature / Characteristic | Predicate Device (ACUSON X300™ - K121699) | Predicate Device (ACUSON X700™ - K141846) | Submission Device (ACUSON NX3™) | Submission Device (ACUSON NX3 Elite™) | Implicit Acceptance Criteria (based on equivalence) | Reported Device Performance (based on equivalence) |
|---|---|---|---|---|---|---|
| Indications for Use (General) | Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Intracardiac, Trans-esophageal, Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal | Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Intracardiac, Trans-esophageal, Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal | Fetal, Abdominal, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult), Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal (some marked 'N' for new) | Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal (some marked 'N' for new) | Performance equivalent to predicates across all listed and new applications. | Device can perform all listed applications using various modes. |
| Center Frequencies (MHz) | 2.0 - 11.0 MHz (some covered by K121699/K141846) | 2.0 - 13.0 MHz (some covered by K121699/K141846) | 2.0 - 11.0 MHz | 2.0 - 13.0 MHz | Offer a comparable range of center frequencies for various applications. | The devices support frequencies within the established range of predicate devices. |
| Modes of Operation | B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI | B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI | B, M, PWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI | B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI | Provide all standard ultrasound modes and functions found in predicates. | Device offers comprehensive set of diagnostic modes. |
| Features (e.g., SieClear, 3D/4D Imaging, Stress Echo, AHP) | Most listed features present in K121699 and/or K141846 | Most listed features present in K121699 and/or K141846 | Most listed features present (some marked with '-' indicating absence or different implementation) | Most listed features present (some marked with '√' indicating presence, 'N' for new) | Provide equivalent or enhanced features compared to predicates. | Device includes a variety of advanced imaging and analysis features. |
| Safety and EMC Requirements | Conforms to UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, 93/42/EEC, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6, IEC 62366, ISO 10993-1 | Conforms to above standards | Conforms to above standards | Conforms to above standards | Meet all applicable medical device safety standards. | Devices undergone evaluation for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety, and conform to listed standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of efficacy studies for this type of 510(k). The clinical performance is inferred from the established safety and efficacy of the predicate devices. The document does mention "nonclinical tests" for safety and standards compliance, but does not provide specific sample sizes for these tests (e.g., number of units tested for electrical safety).
- Data Provenance: Not applicable. The FDA's basis for substantial equivalence for this diagnostic ultrasound system does not rely on a new clinical study with a specific test set. It relies on technological comparison to predicate devices and adherence to recognized performance standards. If clinical data were used from predicate devices, their provenance would be relevant, but this is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth establishment by experts for a novel efficacy claim is described or needed for this 510(k) submission as it relies on substantial equivalence to existing technology. The "ground truth" for the predicate devices' efficacy would have been established historically through their own development and clearance processes.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of a test set requiring adjudication in this 510(k) submission.
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 document pertains to the clearance of a diagnostic ultrasound system and its transducers, which are imaging devices. It does not describe an AI-powered diagnostic algorithm or a clinical study that would involve human readers and AI assistance. The "Arterial Health Package (AHP) software" mentioned for the ACUSON NX3 Elite is described as providing "the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies," not as an AI requiring a MRMC study for improved human reading.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a 510(k) for an ultrasound imaging system, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a new efficacy claim. For the purposes of this 510(k), the "ground truth" for demonstrating substantial equivalence is the comprehensive body of knowledge and regulatory clearance history associated with the predicate devices and general ultrasound technology, as well as adherence to established medical device safety and performance standards (e.g., IEC, ISO, AIUM/NEMA).
8. The Sample Size for the Training Set:
- Not applicable. This submission describes the clearance of an imaging hardware system, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no machine learning model or training set described in this 510(k) submission, this question is not relevant.
§ 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.