(28 days)
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), 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 P200 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 and Harmonic Imaging on a Display.
The provided document does not contain information about specific acceptance criteria related to a device's performance that would be typically found in a clinical study for an AI/ML device (e.g., accuracy, sensitivity, specificity).
Instead, this 510(k) summary focuses on establishing substantial equivalence of the ACUSON P200 Diagnostic Ultrasound System to previously cleared predicate devices. This means that for general diagnostic ultrasound systems like this, clinical performance metrics that would require "acceptance criteria" based on a study, as understood for AI/ML devices, are typically not required. The substantial equivalence is demonstrated by showing that the new device has the same intended use and similar technological characteristics as the predicates, and that non-clinical tests (acoustic output, biocompatibility, safety, etc.) meet established standards.
Therefore, many of the specific questions you asked concerning acceptance criteria and study details (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm) are not applicable to the information provided in this 510(k) summary for the ACUSON P200 Diagnostic Ultrasound System.
The document explicitly states:
- "Since the ACUSON P200 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Page 21, Section 8)
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
Since no specific performance-based acceptance criteria for clinical efficacy (like sensitivity or specificity) are provided for this ultrasound system, a table in the format you requested cannot be fully generated. The "performance" demonstrated for substantial equivalence is primarily through equivalence in intended use, technological characteristics, and compliance with general safety and performance standards.
The document states compliance with various standards as evidence of performance. These implicitly act as "acceptance criteria" for the non-clinical aspects.
| Acceptance Criterion (Type) | Reported Device Performance/Compliance |
|---|---|
| Non-Clinical Performance | |
| Acoustic Output | Conforms to AIUM/NEMA UD-3:2004, AIUM/NEMA UD-2:2004 (R2009), IEC 62359:2010 |
| Biocompatibility | Tested to ISO 10993-1 |
| Cleaning and Disinfection Effectiveness | Conforms to applicable medical device safety standards |
| Thermal Safety | Conforms to applicable medical device safety standards |
| Electromagnetic Safety | Conforms to AAMI ES60601-1:2005/(R)2012, IEC 60601-1:2005, IEC 60601-1-2 Edition 4.0 2014-02 |
| Mechanical Safety | Conforms to applicable medical device safety standards |
| Product Safety Standards | UL 60601-1 Certified, IEC 60601-2-18: Edition 3.0 2009-08, IEC 60601-2-37 Edition 2.1 2015 |
| Intended Use | |
| Fetal | Matches predicate (K180067) |
| Abdominal | Matches predicate (K180067) |
| Pediatric | Matches predicate (K180067, K183575) |
| Small Organ | Matches predicate (K180067) |
| Cardiac | Matches predicate (K180067, K183575) |
| Neonatal Cephalic | Matches predicate (K183575 via ACUSON S3000) |
| Trans-esophageal | Matches predicate (K183575 via ACUSON S3000) |
| Transrectal | Matches predicate (K180067) |
| Transvaginal | Matches predicate (K180067) |
| Peripheral vessel | Matches predicate (K180067) |
| Musculo-skeletal (conventional) | Matches predicate (K180067) |
| Musculo-skeletal (superficial) | Matches predicate (K180067) |
| Technological Characteristics | |
| Frequencies Supported | 1.0MHZ~18MHz (Matches predicate K180067) |
| Modes | B, M, PWD, CWD, PW DTI, Color Doppler, Power Doppler, Combined (BMDC) (Matches predicate K180067) |
| Features | Harmonics, Compounding, UltraArt Universal Image processing, Tissue Equalization (TEQ), Biopsy, Clarify, Cardiac Imaging, Speed of Sound, Protocols, DICOM, eSie Calcs, Wireless, Virtual Touch Strain Imaging, Virtual Touch Point Shear Wave (VTQ), Virtual Touch Shear Wave (VTIQ), Contrast Agent Imaging, eSie OB, eSie Left Heart, eSie Measure, eSie Follicle, Panoramic Imaging, Stress Echo, Syngo Velocity Vector Imaging (VVI), eSieLink, DICOM SR (Matches one or more predicates: K180067, K180039, K183575) |
| Touch Screen | 13.3" (Predicate K180067 lists 15") |
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. Clinical studies were not required. The "test set" here would refer to the technical evaluations and comparisons to predicate devices.
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. Clinical studies were not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Clinical studies were not required.
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 is a diagnostic ultrasound system, not an AI/ML diagnostic aid. Clinical studies were not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an AI/ML diagnostic aid. Clinical studies were not required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Clinical studies were not required. The "ground truth" for demonstrating substantial equivalence is based on established performance specifications, regulatory standards, and the technological characteristics of predicate devices.
8. The sample size for the training set
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device that undergoes training with a dataset.
9. How the ground truth for the training set was established
Not applicable. This is a diagnostic ultrasound system, not an AI/ML device.
§ 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.