(105 days)
The ACUSON P500 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 (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN(useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.
The system also provides the ability to measure 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 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 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.
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 imaging."
The ACUSON P500 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 bioeffect 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, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.
This document is a 510(k) summary for the ACUSON P500 Ultrasound System, seeking clearance for a modified device. It declares substantial equivalence to previously cleared predicate devices by the same company, the ACUSON P500 (K163396), ACUSON Juniper (K201130), and ACUSON Redwood (K210743).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present specific quantitative acceptance criteria or corresponding reported device performance values in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, asserting that the modified ACUSON P500 Ultrasound System (this submission) operates in the same manner and has similar technological characteristics as the previously cleared devices.
The "Determination of Substantial Equivalence" section (page 6-8) lists the features and characteristics of the submitted device and compares them to the predicate and reference devices. The core argument for acceptance is that the added features (transducers, applications, software features) and expanded clinical applications were already cleared on the reference devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (page 11, Section 8).
Therefore, there is no specific test set or associated sample size for a clinical study to prove the device meets acceptance criteria. The data provenance for performance relies on the previous clearances of the predicate and reference devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
As no new clinical study was conducted for this submission, there were no experts specifically engaged to establish ground truth for a new test set for this clearance. The ground truth for the predicate and reference devices would have been established during their respective clearance processes.
4. Adjudication Method for the Test Set:
Since no new clinical study testing performance was performed for this 510(k), no adjudication method was specified or used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI-assisted performance or its effect size on human readers. The ACUSON P500 is an ultrasound system with various imaging modes and measurement packages, not an AI-driven diagnostic assistance tool in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document does not report any standalone algorithm performance studies. The device is an ultrasound system intended for use by "appropriately trained healthcare professional in a clinical setting" (page 2, 5).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
As per the answer to point 2, no new clinical study was conducted for this submission. The basis for clearance is substantial equivalence to existing devices. Therefore, no new ground truth was established for this specific submission. The original ground truth for the clearances of the predicate and reference devices would have been established through methods appropriate for diagnostic ultrasound systems (e.g., expert interpretation of images, correlation with other diagnostic modalities or clinical outcomes). The Arterial Health Package (AHP) software, a feature of the device, references "normative tables that have been validated in peer-reviewed studies," which implies a form of ground truth based on established medical knowledge and research.
8. The Sample Size for the Training Set:
Since no new clinical study or algorithm development (in the context of this clearance) requiring a training set is discussed, no training set sample size is reported.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed for this submission, the method for establishing its ground truth is not applicable or provided.
§ 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.