(30 days)
The ACUSON P500 ultrasound imaging system is intended for the following applications:
Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) 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 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.
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 Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The ACUSON P500™ Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system 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, Power (Amplitude) Doppler Mode and a combination of modes on a Flat Panel Display.
I understand you're looking for information on the acceptance criteria and the study proving the device meets those criteria for the ACUSON P500 Ultrasound System (K163396).
Based on the provided document, which is an FDA 510(k) Premarket Notification, there is a key piece of information that dictates the nature of the "study" that proves the device meets acceptance criteria:
"Since the ACUSON P500™ Ultrasound System uses the same technology and principles as existing devices, clinical data is not required." (Page {24}, Section F)
This statement means that the device's substantial equivalence to previously cleared predicate devices is established primarily through non-clinical testing and comparison of technological characteristics, rather than through a new, a-la-carte clinical effectiveness study with human subjects. Therefore, many of the questions regarding sample size, expert adjudication, MRMC studies, and ground truth for a clinical study would not be applicable in this context.
Here's a breakdown of the information that is available in the document, formatted to answer your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on substantial equivalence to predicate devices rather than reporting specific performance metrics against pre-defined quantitative acceptance criteria from a standalone clinical study. The acceptance criteria essentially stem from demonstrating that its features, indications for use, and technological characteristics are equivalent to the cleared predicate devices, and that it meets relevant safety and performance standards.
The table below summarizes the comparison of the ACUSON P500 Submission Device against several predicate devices for Indications for Use and Modes, which serves as the primary "performance" data to establish substantial equivalence. Where a feature is present in the submission device, it is considered to meet the "acceptance criteria" of being equivalent to or better than a predicate possessing that feature.
Table: Acceptance Criteria (Equivalence to Predicates) and Reported Device Performance (Presence of Feature)
| Feature / Characteristic | Acceptance Criterion (Presence in a Predicate) | Reported Device Performance (Presence in ACUSON P500 Submission Device) |
|---|---|---|
| Indications for Use: | ||
| Fetal | Present in ACUSON Freestyle, X700, NX2, P500 (K150050) | √ (Present) |
| Abdominal | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Small Organ | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Cardiac | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Transrectal | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Transvaginal | Present in ACUSON X700, NX2, P500 (K150050) | √ (Present) |
| Peripheral vessel | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Musculo-skeletal (conventional) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Musculo-skeletal (superficial) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Emergency Medicine | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Intracardiac | Present in ACUSON X700, SC2000 | √ (Present) |
| Modes: | ||
| B | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| M | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| PWD (Pulsed Wave Doppler) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| CWD (Continuous Wave Doppler) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| D (Color Doppler) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Power Doppler (Amplitude Doppler) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Combined (BM, BC, BCM, BCD) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| THI (Tissue Harmonic Imaging) | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| M-THI | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Features: | ||
| Panoramic 2D Imaging (SieScape) | Present in ACUSON X700, NX2 | √ (Present) |
| Dual-Beam Processing | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Quad-Beam Processing | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Spectral DTI | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| Stress Echo | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| 2D (color) DTI | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| DIMAQ (PIMS Workplace) | Present in ACUSON X700, NX2, P500 (K150050) | √ (Present) |
| Vascular Enhancement (Clarify VE) | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| eSielmage | Present in ACUSON P500 (K150050) | √ (Present) |
| Advance SieClear | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Multiple Frequency Imaging (MultiHertz) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Digital Architecture | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| DICOM SR Vascular | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| DICOM SR OB/GYN | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| DICOM SR Cardiac | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| Dynamic TCE | Present in ACUSON X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Syngo AHP | Present in ACUSON X700, SC2000, NX2 | √ (Present) |
| eSieScan | Present in ACUSON SC2000 | √ (Present) |
| Enhanced Needle Visualization | Present in ACUSON Freestyle | √ (Present) |
| Probe Saver | Present in ACUSON Freestyle | √ (Present) |
| Intracardiac Echocardiography (ICE) Imaging | Present in ACUSON X700, SC2000 | √ (Present) |
| CARTOSOUND Communication | Present in ACUSON X700, SC2000 | √ (Present) |
| Monitor: 15.4"WXGA (FPD) | Present in P500 (K150050) | √ (Present) |
| Wireless | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| # Channels (64) | Present in ACUSON Freestyle, NX2, P500 (K150050) | √ (Present) |
| Output Display Standard (Track 3) | Present in ACUSON Freestyle, X700, SC2000, NX2, P500 (K150050) | √ (Present) |
| Patient Contact Materials | All predicates tested to ISO 10993-1 | Tested to ISO 10993-1 |
| ANSI/AAMI ES 60601-1 Certified | All predicates UL60601-1 certified | √ (Certified) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
As explicitly stated, clinical data (and thus a clinical test set with human data) was not required for this 510(k) submission as the device uses the same technology and principles as existing cleared devices. Therefore, there is no sample size for a clinical test set or information on data provenance.
The "test set" in this context refers to the comparison of the device's technical specifications against established standards and predicate devices (as shown in the table above and Section E of the document).
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 a clinical study with human patients requiring expert ground truth was not performed. The "ground truth" for the device's substantial equivalence is established by its adherence to recognized standards and its equivalent technical characteristics to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical study requiring expert adjudication was not performed.
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 type of study is for evaluating the effectiveness of a device when used by human readers, often involving AI. As no clinical study was required, no MRMC study was performed, and the device is a diagnostic ultrasound system, not explicitly described as having an AI assistance feature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is typically relevant for AI/Machine Learning devices. The ACUSON P500 is a diagnostic ultrasound system. While it has proprietary software and calculation packages (like Arterial Health Package), the document does not describe it as an "AI algorithm only" device. Its performance is inherent in its ability to acquire and display ultrasound data and perform measurements. The non-clinical tests relate to the physical and software functioning of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests mentioned (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic and mechanical safety), the "ground truth" refers to the established requirements and limits defined by the referenced voluntary standards (e.g., ANSI/AAMI ES 60601-1, AIUM/NEMA UD-3, IEC 62359, ISO 10993-1). The device is found to "conform with applicable medical device safety standards" (Page {24}, Section E).
8. The sample size for the training set
Not applicable, as a new clinical study or AI model requiring a training set was not described or required for this 510(k) submission. The device's substantial equivalence relies on its underlying technology being 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 was used or described.
§ 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.