Search Results

The Teratech Corporation Terason™ uSmart3400 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

The Terason™ uSmart3400 ultrasound system is a portable, full-featured ultrasound system used to acquire and display high-resolution, real-time ultrasound data using multiple image modes. This system contains a proprietary ultrasound engine (identical to the predicate device Terason t3200 ultrasound system) for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the host singleboard computer (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. Three transducers (15L4, 5C2A, 4V2A) connect to the system using the identical connector to the predicate device, Terason t3200.

The Terason™ uSmart3400 ultrasound EBook weighs 14.6 pounds and has a 15.3" backlit screen. The system dimensions (3.5"(H) x 15.3"(W) x 15.6"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the EBook) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for charging). The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.

The provided information describes a 510(k) summary for the Terason™ uSmart3400 Ultrasound System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device to existing cleared devices rather than providing detailed clinical study results with specific performance metrics against defined acceptance criteria in the manner one might find for a novel AI-powered diagnostic device.

Therefore, the following information is extracted and presented based on the context of this 510(k) summary. Acceptance criteria and performance are primarily discussed in terms of substantial equivalence to predicate devices through technical comparisons and compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness. The "reported device performance" is essentially the comparison of the uSmart3400 and its transducers against the predicate devices across various technical and functional aspects.

Study Details:

Detailed analysis of "studies" within the context of this 510(k) summary:

It's crucial to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, rather than conducting new, large-scale clinical trials that would define novel acceptance criteria and extensive performance metrics. The "studies" referenced are conformity assessments against recognized standards and technical comparisons.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation studies for this 510(k). The "testing" involves technical compliance to standards and comparison of specifications.
• Data Provenance: The data primarily comes from bench testing, engineering analysis, and comparisons to specifications of previously cleared devices.
  • Acoustic output testing was performed per IEC60601-2-37.
  • Biocompatibility testing per ISO 10993 Parts 5 and 10.
  • Electrical and EMC testing per IEC 60601 series and CISPR11.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The ground truth here is the adherence to recognized medical device standards and the established safety and performance characteristics of the predicate devices. Experts involved would be engineers, regulatory specialists, and standard body members who define these compliance requirements, not clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set:

• Not applicable. There is no clinical test set requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is typically conducted for AI-powered diagnostic devices to assess the comparative performance of human readers with and without AI assistance. This 510(k) is for a conventional ultrasound system and does not involve AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This is not an AI algorithm.

7. Type of Ground Truth Used:

• Engineering and Regulatory Standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993, CISPR11): These standards define the "ground truth" for safety, electrical performance, acoustic output, and biocompatibility.
• Predicate Device Specifications and Performance: The performance and safety of the previously cleared predicate devices serve as the benchmark for "ground truth" for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Ask a specific question about this device