(34 days)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal. Abdominal. Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, 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 Sequoia 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, M-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, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.
Theprovided text primarily focuses on the FDA's substantial equivalence determination for the ACUSON Sequoia Diagnostic Ultrasound System, explaining that clinical studies were not required as the device uses the same technology and principles as existing devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical performance study.
However, I can extract the information provided about the device's characteristics and the non-clinical tests relied upon for substantial equivalence.
Here's a breakdown of the available information in relation to your request, highlighting what is not present:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a clinical performance context. The document states that clinical studies were not required for substantial equivalence. The "acceptance criteria" here relate to compliance with regulatory standards and equivalency to predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence and Safety) | Reported Device Performance (as stated in the document) |
|---|---|
| Conformance to applicable medical device safety standards | Device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electromagnetic, and mechanical safety, and conforms to applicable medical device safety standards. |
| Compliance with specific voluntary standards | Complies with: |
- IEC 62359: Edition 2.1 2017-09
- AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- IEC 60601-1:2005
- IEC 60601-1-2 Edition 4.0 2014-02
- IEC 60601-2-18: Edition 3.0 2009-08
- IEC 60601-2-37 Edition 2.1 2015
- ISO 10993-1 Edition 2.1 2017-09 |
| Substantial Equivalence to predicate devices in intended use and technological characteristics | The ACUSON Sequoia Diagnostic Ultrasound System is substantially equivalent to ACUSON Sequoia (K201462) and ACUSON S family (K183575) regarding intended use and technological characteristics. |
| Inclusion of new or improved features | Updated indications for use to add UDFF (Ultrasonically-Derived Fat Fraction), Auto pSWE, Auto IMT, eSieDoppler, Virtual Workstation, and Image Rotate (features previously cleared on predicate/reference devices). |
| Design and development process conforms to quality system regulations | Conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. |
Regarding a clinical study proving device meets acceptance criteria:
The document explicitly states: "Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Page 9)
Therefore, the following information points are not applicable or not available from the provided text for a clinical performance study:
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, as no clinical performance study was conducted.
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, as no clinical performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical performance study was conducted.
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, as no clinical performance study was conducted. The document doesn't mention AI assistance in this context, only new features.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as no clinical performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance study was conducted.
8. The sample size for the training set:
Not applicable, as no clinical performance study was conducted using a training set in the context of a new algorithm requiring performance evaluation.
9. How the ground truth for the training set was established:
Not applicable, as no clinical performance study was conducted using 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.