(12 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The SonoSite TITAN™ high-resolution ultrasound systemis a highly portable. software controlled ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler (VCD) and Directional Color Power Doppler, or in a combination of these modes. The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data for M-mode measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes Digital Imaging and Communications (DICOM) to capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. The SonoSite TITAN™ high-resolution ultrasound system is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
This is a general ultrasound system and hence no specific disease is mentioned. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to various standards for safety and performance. There is no information regarding clinical studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies for AI integration. This is typical for a 510(k) submission for a general-purpose diagnostic ultrasound system.
The "acceptance criteria" for this device are its conformity to recognized industry standards for medical electrical equipment, acoustic output, and biological safety, and its substantial equivalence to predicate devices. The "study" that proves it meets these criteria is the comprehensive testing and documentation demonstrating this conformity and equivalence, as laid out in the 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI EC 53:1995 + Amendments (ECG Cables) | Complies (except for sections 4.4 and 4.5.9) |
| Compliance with CAN/CSA-C22.2, No. 601.1:1998 (Medical Elec. Safety) | Complies |
| Compliance with EN 60529 (Degrees of Protection) | Complies |
| Compliance with EN 60601-1:1997 (Medical Elec. Safety) | Complies |
| Compliance with EN 60601-1-1:1993 (Medical Elec. Systems) | Complies |
| Compliance with EN 60601-1-2:2001 (EMC) | Complies |
| Compliance with EN 60601-2-25:1996 (Electrocardiographs) | Complies |
| Compliance with IEC 61157:1992 (Acoustic Output Declaration) | Complies |
| Compliance with ISO 10993 (Biological Evaluation) | Complies |
| Compliance with JIS-T-100x Series (Japanese Med. Elec. Eq.) | Complies |
| Compliance with AIUM 1994 (Medical Ultrasound Safety) | Complies |
| Compliance with NEMA PS3.15 2000 (DICOM) | Complies |
| Compliance with NEMA UD2-1998 (Acoustic Output Measurement) | Complies |
| Compliance with NEMA UD3-1998 (Real-Time Display Acoustic Output) | Complies; provides on-screen display of thermal and mechanical acoustic output indices. |
| Compliance with RTCA/DO160D:1997, Section 21.0 (RF Emissions) | Complies |
| Compliance with UL 2601-1:1999 (Medical Elec. Safety) | Complies |
| Compliance with UL 94, Fifth Edition (Flammability Plastics) | Complies |
| Acoustic Output Limits (ISPTA(d)) | 720 mW/cm^2 (Maximum) |
| Acoustic Output Limits (TIs/TIb/TIc) | 0.1 - 4.0 (Range) |
| Acoustic Output Limits (Mechanical Index (MI)) | 1.9 (Maximum) |
| Acoustic Output Limits (ISPPA(d)) | 0 - 700 W/cm^2 (Range) |
| Substantial Equivalence to Predicate Devices | The device is deemed substantially equivalent to Philips Ultrasound HDI® 5000 (K011224), GE LOGIQ 9 (K011188), and Siemens OMNIA X/XS (K020353) in terms of modes of operation (2D, PW Doppler, CW Doppler, velocity color Doppler, Color Power Doppler, directional color power Doppler, and duplex imaging) and transducer patient contact materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set or patient data is mentioned in this 510(k) summary. The submission focuses on technical and safety standard compliance and comparison to predicate devices, rather than a clinical performance study with a test set of patient data.
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. The submission does not describe a clinical study requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is described.
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 an AI-powered image analysis tool. Therefore, no MRMC comparative effectiveness study was conducted regarding AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an imaging system, not an algorithm, and does not operate in a standalone algorithmic capacity as described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The submission does not describe a clinical performance study that would require establishing ground truth in this manner. The "ground truth" implicitly relies on established industry standards and the performance of predicate devices.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.