(29 days)
The ACUSON X800 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON X800 Diagnostic Ultrasound System is 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 on a Display.
The provided text is a 510(k) premarket notification for the ACUSON X800 Diagnostic Ultrasound System. This document asserts substantial equivalence to legally marketed predicate devices, rather than proving that a device meets specific acceptance criteria through a study with a test set, expert ground truth, etc. It explicitly states that clinical studies were not required to support substantial equivalence (Section 8 of the summary, page 19).
Therefore, based on the provided document, I cannot fulfill the request for information regarding acceptance criteria and the specifics of a study proving the device meets those criteria, as no such study is presented or required for a 510(k) submission that relies on substantial equivalence to existing devices.
The information provided describes the device's technical characteristics and intended uses, and asserts its similarity to predicate devices already cleared by the FDA. The "acceptance criteria" here are effectively the FDA's regulatory requirements for a 510(k) clearance, which primarily center on demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use and technological characteristics, and conformance to applicable safety standards.
Here's what can be extracted from the document concerning device characteristics based on the provided text, as it relates to comparison with predicates:
1. Table of Acceptance Criteria (Implicitly, Substantial Equivalence Comparison) and Reported Device Performance (vs. Predicates):
The document provides a comparison table (page 18) of the ACUSON X800 against its predicate devices, the ACUSON S family and ACUSON SC2000. For a 510(k), the "acceptance criterion" is effectively demonstrating that the notable differences do not raise new questions of safety or effectiveness.
| Feature / Characteristic | ACUSON X800 (This Submission) | ACUSON S family (K# 172162) | ACUSON SC2000 (K# 170315) | Commentary (Implicit "Performance") |
|---|---|---|---|---|
| Indications for Use: | All common indications are preserved. | |||
| ■ Fetal | √ | √ | -- | |
| ■ Abdominal | √ | √ | -- | |
| ■ Pediatric | √ | √ | -- | |
| ■ Small Organ | √ | √ | -- | |
| ■ Cardiac | √ | √ | -- | |
| ■ Transrectal | √ | √ | -- | |
| ■ Transvaginal | √ | √ | -- | |
| ■ Peripheral vessel | √ | √ | -- | |
| ■ Musculo-skeletal (conventional) | √ | √ | -- | |
| ■ Musculo-skeletal (superficial) | √ | √ | -- | |
| Frequencies Supported: | (1.0MHz~18MHz) | (2.0MHz~17MHz) | -- | Expanded frequency range compared to S family. |
| Modes: | All modes of operation are maintained. | |||
| ■ B | √ | √ | -- | |
| ■ M | √ | √ | -- | |
| ■ PWD (Pulsed Wave Doppler) | √ | √ | -- | |
| ■ CWD (Continuous Wave Doppler) | √ | √ | -- | |
| ■ PW DTI (Doppler Tissue Image) | √ | √ | -- | |
| ■ Color Doppler | √ | √ | -- | |
| ■ Power Doppler | √ | √ | -- | |
| ■ Combined (BMDC) | √ | √ | -- | |
| Features: | Most features are similar or equivalent (e.g., "Native tissue harmonic imaging" vs "Harmonic imaging"). Some features are specifically noted as present in the X800 and previously in a subset of the S family (e.g., Fusion, VTq, VTIQ). | |||
| ■ Native™ tissue harmonic imaging | √ (Harmonic imaging) | √ | -- | |
| ■ SieScape™ panoramic imaging | √ (Panoramic imaging) | √ | -- | |
| ■ Color SieScape™ panoramic imaging | √ (Color Panoramic imaging) | √ | -- | |
| ■ TEQ™ ultrasound technology | √ (Auto TEQ) | √ | -- | |
| ■ Cardiac Imaging physiological signal display | √ | √ | -- | |
| ■ syngo ® Auto OB measurements | √ (eSie OB) | √ | -- | |
| ■ Advanced SieClear™ spatial compounding | √ (Compounding) | √ | -- | |
| ■ Cadence contrast agent imaging | √ (Contrast imaging) | √ | -- | |
| ■ Clarify™ vascular enhancement technology | √ (Clarify) | √ | -- | |
| ■ eSie™ Touch elasticity imaging | √ (Virtual Touch - Strain) | √ | -- | |
| ■ syngo ® Velocity Vector Imaging | √ | √ | -- | |
| ■ Semi Auto-segmentation (eSie Calc) | √ (eSie Calc) | √ | -- | |
| ■ Custom Tissue Imaging / Speed of Sound | √ (Speed of Sound) | √ | -- | |
| ■ eSie Fusion | √ (Fusion) | √ (S3000 only) | -- | |
| ■ VTq | √ (Virtual Touch - pSWE) | √ (S2000 & S3000 only) | -- | |
| ■ VTIQ | √ (Virtual Touch - SWE) | √ (S2000 & S3000 only) | -- | |
| ■ DTCE/RTIE | √ (UltraArt) | √ | -- | |
| ■ MMR (Multi-Modality Review) | √ (Modality Compare) | √ | -- | |
| ■ HD Zoom | √ | √ | -- | |
| ■ eSieScan | √ (Protocols) | √ | -- | |
| ■ InFocus | √ (InFocus) | -- | √ | Feature from SC2000 is included. |
| ■ MBD Burst | √ (Flash sequencing) | √ | -- | |
| ■ Freestyle activating transducer | √ (Gesture control) | -- | -- | New feature for X800. |
| ■ TeamViewer | √ (TeamViewer) | √ | -- | |
| ■ Contrast Agent Image | √ Motion Stabilized Persistence | √ | -- | |
| ■ DICOM | √ (DICOM) | √ | -- | |
| ■ DICOM SR | √ (DICOM SR) | √ | -- | |
| Wireless | √ | √ | -- | |
| Monitor: 21" FPD | √ (OLED) | √ | -- | |
| Touch Screen: 12" Touch Screen | √ (15" adjustable Touch Screen) | √ | -- | Touch screen size difference noted. |
| Output Display Standard (Track 3) | √ | √ | -- | |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | -- | Adherence to bio-compatibility standard. |
| UL 60601-1 Certified | √ | √ | -- | Adherence to electrical safety standard. |
| Indications for Use | √ | √ | -- |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states that "clinical studies were not required to support substantial equivalence." Therefore, no test set, sample size, or specific data provenance information (like country of origin, retrospective/prospective) related to a clinical performance study of the device is provided. The device's compliance is based on its similarity to legally marketed predicates and adherence to harmonized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical performance study with a test set was required or conducted, there were no experts establishing ground truth for such a test set.
4. Adjudication method for the test set:
- Not Applicable. No test set was used for a clinical performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document states that clinical studies were not required. Therefore, an MRMC comparative effectiveness study was not conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is an ultrasound system (hardware and software), not an AI algorithm intended for standalone diagnostic interpretation. Its performance is tied to its use by a human operator.
7. The type of ground truth used:
- Not Applicable. For this 510(k) submission, the "ground truth" for proving substantial equivalence relies on:
- Comparison of technical specifications and features to legally marketed predicate devices.
- Compliance with recognized voluntary safety and performance standards (e.g., AIUM/NEMA UD-3, IEC 62359, ANSI/AAMI ES 60601-1, ISO 10993-1).
- The manufacturer's adherence to quality system regulations (21 CFR 820) and ISO 13485:2003.
8. The sample size for the training set:
- Not Applicable. This is not a submission for an AI/ML device that requires distinct training and test sets in the typical sense of machine learning performance evaluation. The "training" in this context would refer to the historical development and validation of the predicate devices and the engineering and testing processes applied to the new device to ensure it meets its design specifications and safety requirements.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8. The "ground truth" equivalent would be the established performance and safety profiles of the predicate devices and the validation of design specifications against engineering principles and standards.
§ 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.