Search Results

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:

1. Technological Characteristics: The devices are fundamentally the same as their predicates, with the same core function (ultrasound imaging), modes of operation, and most features.
2. 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.

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.

Ask a specific question about this device

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, Adult 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 Parts (Small Orqan including intra-operative), Neonatal Cephalic, Adult Cephalic, 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.
The Arterial Health Package (AHP) software provides the physicial 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 physicial with an easily understood tool for communicating with patients reqarding state of their cardiovascular system.
Note: This feature should 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 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.

The provided document is a 510(k) Pre-market Notification from Siemens Medical Solutions USA, Inc. for their ACUSON NX3 Diagnostic Ultrasound System and ACUSON NX3 Elite Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a de novo clinical study.

Therefore, the document does not contain information on acceptance criteria and specific study details for proving device performance in the way a clinical trial submission would. Instead, it highlights the safety and performance aspects by demonstrating adherence to recognized standards and substantial equivalence to previously cleared devices.

Here's an analysis of the information available in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance in the typical sense of a clinical outcome study. Instead, it demonstrates performance by:

• Indications for Use: Listing the clinical applications for which the device is intended (e.g., Fetal, Abdominal, Pediatric, Cardiac, Vascular, etc.).
• Operating Modes: Stating the various imaging and Doppler modes available (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Power Doppler, Combined modes).
• Supported Frequencies: Listing the range of center frequencies supported by the transducers.
• Features: Enumerating various proprietary features (e.g., Multi-View Spatial Compounding, Syngo Auto OB, Stress Echo, DICOM integration).
• Compliance with Standards: Stating conformance with various international and national standards for medical electrical equipment, acoustic output, and biological evaluation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

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."

Therefore, no clinical test set was used for a primary clinical effectiveness study, and thus no sample size, data provenance (country, retrospective/prospective), or ground truth establishment details are present.

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)

As no clinical data was required or submitted, there is no information regarding experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Since no clinical data was required or submitted, there is no information on any adjudication method.

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

The document is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported, and thus no effect size related to human reader improvement with AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a diagnostic ultrasound system and not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No clinical ground truth data specific to this submission was used or referenced, as clinical data was not required for substantial equivalence. The "ground truth" for demonstrating safety and performance relies on engineering verification, validation against internal specifications, and compliance with recognized standards.

8. The sample size for the training set

This is not applicable, as the submission does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as the submission does not describe an AI/ML device that requires a training set.

Summary of what the document does provide in relation to acceptance criteria and performance:

The document outlines an argument for Substantial Equivalence based on:

• Identical Intended Use: The ACUSON NX3 and NX3 Elite systems share the same intended uses as their predicate devices (ACUSON X300PE (K121699), and previous ACUSON NX3 and NX3 Elite (K152469)). The new indications for specific transducers (marked 'N' in the detailed intended use tables) are presented as extensions to existing cleared technology, not requiring new clinical performance studies.
• Similar Technological Characteristics: The submission device utilizes similar fundamental technological characteristics (e.g., ultrasonic energy transmission, post-processing for display, specialized measurements) as the predicate devices. Differences in features (e.g., specific frequencies supported by new transducers, absence/presence of certain advanced features across models) are compared in a table (pages 25-26) to demonstrate that these differences do not raise new questions of safety or effectiveness.
• Compliance with Safety Standards: The devices have been evaluated and found to conform with applicable medical device safety standards, including:
  • AAMI / ANSI ES60601-1 (general medical electrical equipment safety)
  • IEC 60601-2-37 (ultrasound medical diagnostic equipment specific safety)
  • IEC 60601-2-18 (endoscopic equipment safety - if applicable)
  • CAN/CSA-C22.2 NO. 60601-1
  • AIUM/NEMA UD-3 and UD-2 (acoustic output standards)
  • IEC 62359 (test methods for thermal and mechanical indices)
  • IEC 60601-1-2 (electromagnetic compatibility)
  • ISO 10993-1 (biological evaluation of medical devices)
• Verification and Validation: The products are designed to conform with applicable medical device safety standards, and compliance is verified through independent evaluation with ongoing factory surveillance. The systems are "verified and validated according to the company's design control process." (Page 28)

In the context of this 510(k), the "acceptance criteria" are implied by the requirements for substantial equivalence and compliance with these recognized safety and performance standards. The "study that proves the device meets the acceptance criteria" is the comprehensive engineering and safety testing performed to ensure the device operates as intended and meets the regulatory standards, along with the comparison to legally marketed predicate devices. No new clinical performance study was deemed necessary by the FDA for this particular submission.

Ask a specific question about this device