(68 days)
The Teratech Corporation Terason™ uSmart3200T 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: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.) Musculo-skel. (Convent.), Musculo-skel. (Superfic); Cardiac (Adult & Pediatric); Trans-esophageal (Cardiac) 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 5 transducers (9MC3, 8TE3, PDOF, 8L2, 8V3A), the Trans-esophageal (non-Cardiac and Cardiac) IFUs and the Ophthalmic IFU associated with the 12L5A and 15L4 transducers with no change to the tablet-style computer form factor.
The document provided is a 510(k) premarket notification for the Terason uSmart3200T Ultrasound System, detailing its substantial equivalence to predicate devices. It focuses on the safety and performance aspects of the device and its transducers.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated manner for the entire device. Instead, it describes various tests and standards met. However, it does provide specific acoustic output limits and the measured values for different transducers.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance (Worst Case for each Transducer) |
|---|---|---|
| Acoustic Output | NEMA UD 2-2004, NEMA UD 3-2004, IEC 60601-2-37 | |
| Global Maximum ISPTA.3 | - 12L5A: 597 mW/cm² | |
| - 4V2A: 603 mW/cm² | ||
| - 5C2A: 660 mW/cm² | ||
| - 8EC4A: 633 mW/cm² | ||
| - 16HL7: 554 mW/cm² | ||
| - 15L4: 563 mW/cm² | ||
| - 8L2: 598 mW/cm² | ||
| - 8V3A: 560 mW/cm² | ||
| - 9MC3: 577 mW/cm² | ||
| - 8TE3: 245 mW/cm² | ||
| - PDOF: 506 mW/cm² | ||
| TI (Thermal Index) | - 12L5A: 3.3 | |
| - 4V2A: 5.6 | ||
| - 5C2A: 4.7 | ||
| - 8EC4A: 2.29 | ||
| - 16HL7: 1.22 | ||
| - 15L4: 5.8 | ||
| - 8L2: 2.8 | ||
| - 8V3A: 4.7 | ||
| - 9MC3: 2.8 | ||
| - 8TE3: 1.0 | ||
| - PDOF: 4.2 | ||
| MI (Mechanical Index) | - 12L5A: 1.8 | |
| - 4V2A: 1.5 | ||
| - 5C2A: 0.7 | ||
| - 8EC4A: 1.8 | ||
| - 16HL7: 1.6 | ||
| - 15L4: 1.7 | ||
| - 8L2: 1.7 | ||
| - 8V3A: 1.7 | ||
| - 9MC3: 1.3 | ||
| - 8TE3: 1.3 | ||
| - PDOF: 0.1 | ||
| B-Mode Accuracy | AIUM Quality Assurance Manual for Gray-Scale Ultrasound Scanners | Evaluated (details not specified) |
| Doppler Accuracy | AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices | Evaluated (details not specified) |
| Doppler Sensitivity | AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices | Evaluated (details not specified) |
| Electrical Safety | IEC60601-1 | Compliance verified |
| EMC | IEC 60601-1-2, CISPR11 Class B | Compliance verified |
| Usability | IEC60601-1-6 | Compliance verified |
| Biocompatibility | ISO 10993 Part 5 and Part 10 | Biocompatibility reports fulfilled |
| Software | IEC 62304 (Software Life Cycle Process), IEC 62366 (Application for Usability) | Undergone Quality Assurance testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a specific test set of patient data. The studies performed are primarily non-clinical bench tests on the ultrasound system and its transducers.
- Data Provenance: Not applicable as the documented tests are primarily for physical and technical performance and safety, not diagnostic accuracy on patient data. The document mentions acoustic tank evaluations for transducers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported tests are not clinical studies that require expert-established ground truth on patient cases. They are technical performance evaluations against engineering standards and specifications.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set with patient data requiring expert consensus or adjudication 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. The document describes the system's technical and safety characteristics, not its comparative effectiveness in a clinical reading environment with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical imaging device, not a standalone algorithm. The "performance" discussed relates to the physical and technical capabilities of the ultrasound system and its transducers.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" for the tests performed is primarily based on technical standards and specifications (e.g., NEMA UD 2, NEMA UD 3, IEC 60601-2-37 for acoustic output; AIUM guidelines for B-Mode and Doppler accuracy/sensitivity; ISO 10993 for biocompatibility). For a diagnostic device, the "ground truth" is that it performs according to these established and recognized technical and safety benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a hardware-based diagnostic imaging system, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI model or training set described in this document.
§ 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.