(27 days)
The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
The system also provides the ability to measure anatomical structures analysis packages that provide information used by a physician 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 svstem.
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 P600 Diagnostic Ultrasound System is a 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, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue 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 does not contain explicit acceptance criteria and corresponding study results with performance metrics that would typically be reported in a clinical trial. Instead, it is a 510(k) summary for the ACUSON P600 Diagnostic Ultrasound System, asserting substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)
The document does not detail specific quantitative acceptance criteria or performance metrics for the ACUSON P600 Diagnostic Ultrasound System itself because it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices, rather than proving novel performance.
The "Substantial Equivalence" table (pages 22-23) serves as a comparison of features and intended uses between the submission device (ACUSON P600) and its predicate devices (ACUSON X700, ACUSON SC2000, ACUSON S2000, ACUSON P500). For each listed indication, mode, and feature, the presence ("√") or absence ("-") in both the predicate and submission device is noted. All features present in the ACUSON X700 (K141846), which is used as the primary predicate for most features, are indicated as being present in the ACUSON P600. Similarly, some features from other predicates (SC2000, S2000, P500) are also indicated as being present in the ACUSON P600.
Therefore, the "acceptance criteria" here is that the ACUSON P600 meets the same intended uses, modes, and features as the predicate devices. The "reported device performance" is implicitly that it performs equivalently to these cleared devices, as no new performance claims are being made that would require specific new benchmarks.
Study Information:
1. A table of acceptance criteria and the reported device performance
As explained above, explicit quantitative acceptance criteria for performance are not provided. The study relies on demonstrating feature equivalence to predicate devices. The table on pages 22-23 serves as the comparison for "acceptance criteria" (i.e., matching predicate features) and "reported device performance" (i.e., presence of those features in the P600).
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 P600 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical data is not required." (Page 25) This indicates that no new clinical test set was used to establish performance. Therefore, there is no information on sample size, data provenance, or retrospective/prospective nature of a clinical test set. The submission relies on non-clinical tests (Page 24) to ensure safety and effectiveness.
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 test set was required or performed for performance evaluation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was required or performed for performance evaluation 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 device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device clearance for a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical test set was used to establish performance. The ground truth for substantiating the predicate devices would have been previously established through their respective clearance processes.
8. The sample size for the training set
Not applicable, as no new clinical test set or algorithm training is mentioned for this 510(k) submission. The device relies on
"the same technology and principles as existing devices."
9. How the ground truth for the training set was established
Not applicable, as no training set for a new algorithm is mentioned in this document.
§ 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.