(20 days)
For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, 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.
For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), 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. 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.
The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
This document is a 510(k) premarket notification from Siemens Medical Solutions USA, Inc. for their ACUSON NX3 Diagnostic Ultrasound System and ACUSON NX3 Elite Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices (K173957).
Analysis of Acceptance Criteria and Study Design:
This document describes a submission for a change to Indications for Use for an existing device, rather than a clinical study establishing performance of a new device or software. Therefore, the typical structure of acceptance criteria and a study design proving a device meets these criteria (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) is not present in this document.
Instead, the document asserts substantial equivalence based on:
- Technological Characteristics: The devices are fundamentally the same as their predicates, with the same core function (ultrasound imaging), modes of operation, and most features.
- Expanded Indications for Use: The main purpose of this submission is to expand the stated Indications for Use for the existing ACUSON NX3 and ACUSON NX3 Elite systems, and specifically to update the Indications for Use for the VF13-5sp transducer. These expansions primarily involve applications (e.g., "cardiac (including transesophageal)" and "small parts to the intra-operative clinical application") that were already cleared on the predicate devices or with other transducers.
Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" as typically applied to performance claims (e.g., for an AI/ML algorithm) needs to be reinterpreted in the context of a 510(k) for an updated Indications for Use of an existing ultrasound system.
Therefore, the "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for an expanded intended use, which primarily relies on technological similarity and safety/performance data already established for the predicate device.
Here's an attempt to answer your questions based on the provided document, noting that many items will be answered as "Not Applicable" or "Not Provided" because this is a 510(k) for an existing device with expanded indications, not a performance study for a novel AI/ML algorithm:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) for expanding indications of an existing ultrasound system, not a new AI/ML device with specific performance claims (e.g., sensitivity, specificity), a direct "acceptance criteria" table with performance metrics isn't explicitly defined in the document. The acceptance criterion is "substantial equivalence" to the predicate, demonstrated by listing comparable technological characteristics and intended uses.
| Acceptance Criterion (Implicit for 510(k) of Expanded Indications) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Safety and Effectiveness (comparable to predicate) | Confirmed through compliance with applicable medical device safety standards (AIUM/NEMA UD-3:2004, AIUM/NEMA UD-2:2004 (R2009), IEC 62359:2010, AAMI ES60601-1:2005, IEC 60601-1:2005, IEC 60601-1-2 Edition 4.0, IEC 60601-2-18: Edition 3.0, IEC 60601-2-37 Edition 2.1, ISO 10993-1). |
| Technological Characteristics (substantially equivalent to predicate) | All listed features (Indications for Use, Center Frequencies, Modes, Features like 3D/4D Imaging, Stress Echo, DICOM, etc.) are identical between the submission devices and their respective predicate devices (ACUSON NX3 and ACUSON NX3 Elite K173957), as indicated by the "√" in the comparison table. Some indications are new to specific device/transducer combinations but were previously cleared on other parts of the predicate system. |
| Intended Use (consistent with predicate and traditional clinical practice) | Expanded indications ("cardiac (including transesophageal)" and "small parts to intra-operative clinical application" for VF13-5sp transducer) were already cleared either on the predicate device or with other transducers in the predicate system. The information for Arterial Health Package (AHP) is referenced to peer-reviewed studies and professional consensus statements. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission is for expanded indications of an existing ultrasound system, not a clinical study with a test set for performance evaluation of a new algorithm. The manufacturer states that "clinical data is not required" because the devices use the "same technology and principles as existing devices."
- Data Provenance: Not applicable for a new clinical study. The existing data supporting the predicate device's clearance would have been used. The document does not specify the provenance of data for the original predicate clearance (K173957), but it did not rely on
clinical data. The AHP feature references peer-reviewed studies, but these are not for the device's performance, but for the underlying normative tables.
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. No new clinical test set requiring expert-established ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical test set requiring adjudication was performed for 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 is not an AI-assisted device; it is a diagnostic ultrasound system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a diagnostic imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a new clinical study. The existing predicate device was cleared without new clinical data. The AHP feature bases its normative tables on "peer-reviewed studies" and "ASE Consensus Statement."
8. The sample size for the training set:
- Not applicable. This is hardware (ultrasound system) with software, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is hardware (ultrasound system) with software, not a machine learning model.
§ 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.