(28 days)
The ACUSON P500 ultrasound system is intended for diagnostic ultrasound imaging and fluid flow analysis for the following applications: Fetal, Abdominal, Small Parts, OB/GYN, Pelvic, Cardiovascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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 ACUSON P500 is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect 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, Tissue Doppler Image, Power (Amplitude) Doppler Mode and a combination of modes on a Flat Panel Display.
This document is a 510(k) Premarket Notification from Siemens Medical Solutions USA, Inc. for their ACUSON P500 Ultrasound System, submitted to the FDA on January 12, 2015. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, the ACUSON X300 ultrasound system (K121699) and the ACUSON S2000 ultrasound system (K140959).
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the ACUSON P500 ultrasound system itself. Instead, it demonstrates substantial equivalence to predicate devices based on:
- Identical Indications for Use: The ACUSON P500 shares the same intended uses as the predicate devices across various applications (Fetal, Abdominal, Small Organ, Cardiac, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal (conventional), Musculo-skeletal (superficial), Emergency Medicine).
- Similar Technological Characteristics: The document provides a detailed comparison table (Page 5) showing that the ACUSON P500 largely shares:
- Supported Center Frequencies (2.0 MHz to 11.0 MHz across the board for all three devices).
- Imaging Modes (B, M, PWD, SCW, Color Doppler, Power Doppler, Combined modes, THI, M-THI are all present in the P500 and the predicates).
- Many Features (e.g., Dual-Beam Processing, Quad-Beam Processing, Clip Capture, DIMAQ, Multiple Frequency Imaging, Digital Architecture, DICOM, Dynamic TCE, Wireless functionality).
- Compliance with Safety Standards: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards like UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601 series, EN/IEC 62304, EN/IEC 62366, and ISO 10993-1.
Reported Device Performance (by inference of substantial equivalence):
Based on the assertion of substantial equivalence, the implied "performance" of the ACUSON P500 is considered to be equivalent to that of the predicate devices. The document does not provide specific numerical performance metrics (e.g., sensitivity, specificity, resolution) for the ACUSON P500 or its predicates. It focuses on functional equivalence.
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 under "F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence": "Since the P500 uses the same technology and principles as existing devices, clinical data is not required."
Therefore, no clinical test set was required or used for this 510(k) submission. The entire evaluation for substantial equivalence was based on non-clinical tests (engineering, safety, and performance characteristic comparisons to predicates).
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 data/test set was required, no experts were needed to establish ground truth for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set was used.
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. The document is for an ultrasound system, not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a diagnostic ultrasound system, not a standalone AI algorithm. Its performance is inherent to its hardware and software for image acquisition and display, which are deemed substantially equivalent to existing devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. As no clinical data/test set was required, no ground truth was established for this submission. The "ground truth" for the FDA's substantial equivalence determination here relies on the established safety and effectiveness of the predicate devices and the P500's compliance with recognized safety standards through non-clinical testing.
8. The sample size for the training set:
Not applicable. The document describes a medical device seeking 510(k) clearance based on substantial equivalence to existing predicate devices, not an AI/machine learning device that would typically involve a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.