(41 days)
The Teratech Corporation Terason™ uSmart3200T is a prescription-only, general-purpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging or fluid flow analysis of the human body. The device is intended for use in a clinic, hospital or medical-emergency setting, Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (noncardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
The Terason uSmart3200T ultrasound system is a portable tablet-style, fullfeature, general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 6 transducers (5V1A. 15L4A. 16L5, 15WL4. XY-Biplane, 10EC4), the Ophthalmic IFU associated with the 15L4A transducer with no change to the tablet-style computer form factor.
The Terason™ uSmart3200T ultrasound system was the previously cleared on the date May 9, 2015 as described in the 510(k) submission (K150533). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a Universal Serial Bus (USB3) connection for further processing and generation/display of the ultrasound image.
The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11.5" backlit touch screen. The tablet dimensions (8.82"(H) x 12.64"(W) x 1.25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the uSmart3200T. Optional accessories include a cart and printer.
The provided text is a 510(k) summary for the Terason uSmart3200T Ultrasound System. It describes the device, its intended use, and a comparison to a predicate device, focusing on safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device concerning:
- Intended Use and Indications for Use: The intended uses are the same.
- Technological Characteristics: The core technology (ultrasound engine, portable form factor) is the same. The differences are the addition of new transducers and an updated data connection (USB3 vs. FireWire).
- Safety and Performance Benchmarking: Compliance with recognized electrical safety, EMC, acoustic output, and biocompatibility standards is demonstrated.
Therefore, I cannot provide the requested information about acceptance criteria for diagnostic accuracy or a study proving the device meets such criteria, as that information is not present in the given text.
However, I can extract the information related to the conformity of the device to regulatory standards and basic performance checks which serve as the "acceptance criteria" and "study" in the context of this 510(k) submission.
Here is the information based on the provided text, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the testing performed to demonstrate this compliance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance demonstrated) |
|---|---|
| Safety Standards | |
| AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 | Compliant – Medical electrical equipment – Part 1: General requirements for safety and essential performance |
| IEC60601-1-6 | Compliant – Medical Electrical Equipment Part 1-6: General requirements for safety- Collateral standard: Usability |
| IEC 60601-1-2:2007 | Compliant – Medical Electrical Equipment Part 1-2; General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility - Requirements and tests (EMC Test Report for the Terason uSmart3200t provided) |
| IEC 60601-2-37 / EN60601-2-37 | Compliant – Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (Acoustic testing performed per this standard for all new transducers) |
| Biocompatibility Standards | |
| ISO 10993 Part 5, Part 10 and Part 12 | Compliant – Biocompatibility Tests (Biocompatibility reports for the new transducers provided; patient contact materials like Silicone Valox and RTV 630 for different transducers are noted as biocompatible or passed biocompatibility tests) |
| AAMI TIR No. 12:210 | Compliant – Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers |
| Acoustic Output Standards | |
| IEC 61157 Ed. 2 2007-2008 | Compliant – Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment |
| NEMA UD 2 | Compliant – Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3 |
| NEMA UD 3 | Compliant – Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2 |
| Image Quality/Performance Standards | |
| AIUM Quality Assurance Manual for Gray-Scale Ultrasound Scanners | Compliant – B-Mode Accuracy evaluated. |
| AIUM Methods for Measuring Performance of Pulse-Echo Ultrasound Imaging Equipment, Part II: Digital Methods | Compliant – Performance measures conducted. |
| AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices | Compliant – Doppler Accuracy and Doppler Sensitivity evaluated. |
| Software Standards | |
| IEC 62304 | Compliant – Software Life Cycle Process (Software has undergone Quality Assurance testing consistent with this standard) |
| IEC 62366 | Compliant – Application for Usability (Software has undergone Quality Assurance testing consistent with this standard) |
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 describes non-clinical bench testing to evaluate the device's adherence to various technical and safety standards. There is no mention of a clinical test set, human subject data, or data provenance (country of origin, retrospective/prospective study) in the context of diagnostic performance. The testing involved the equipment itself.
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)
This information is not applicable as the evaluation was based on non-clinical bench testing against established performance and safety standards, not on clinical assessment requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation was based on non-clinical bench testing against established performance and safety standards, not on clinical assessment requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader performance evaluation in this document. The device is a diagnostic ultrasound system, not an AI-enabled diagnostic tool in the sense of image analysis/interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device described is a hardware/software system for ultrasound imaging, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was the specified parameters and limits within the cited international and national standards (e.g., acoustic output limits, electromagnetic compatibility limits, image quality phantoms/measurements). There was no clinical ground truth (pathology, expert consensus, outcomes data) involved for this regulatory submission.
8. The sample size for the training set
This information is not applicable. The context is a 510(k) premarket notification for an ultrasound system, not a machine learning model that undergoes training on a dataset.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of this device's regulatory submission.
§ 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.