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The Teratech Corporation Terason™ uSmart3200T Plus 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 (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

The Terason uSmart3200T Plus 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 Plus Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers: 14L3, 10BP4 and 15XL4.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date January 29, 2020 as described in the 510(k) submission (K193510). 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 Plus ultrasound tablet weighs 9.8 pounds (4.2 Kq) and has an 15.6" backlit touch screen. The tablet dimensions (10.6"(H) x 15.6"(W) x 1.7"(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 Plus. Optional accessories include a cart and printer.

This document is a 510(k) Pre-market Notification for a medical device, specifically an ultrasound system. It is a submission to the FDA for a new version of an existing device (Terason uSmart3200T Plus Ultrasound System). The focus of this submission is to demonstrate substantial equivalence to a previously cleared device, primarily by showing that changes (adding three new transducers and some system characteristics) do not raise new questions of safety or effectiveness.

Therefore, this document does not contain a multi-reader, multi-case (MRMC) comparative effectiveness study, nor does it present acceptance criteria and performance data for a new AI/algorithm-based diagnostic device in the way you've outlined. Instead, it focuses on bench testing and comparisons to established safety and performance standards for ultrasound systems and transducers.

Here's how the provided information relates to your requested points, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit via Standards): The document implicitly states its acceptance criteria by referencing compliance with various international standards for medical electrical equipment, including:

  • AAMI/ANSI ES 60601-1 (general safety)
  • IEC 60601-1-6 (usability)
  • IEC 60601-1-2 (EMC)
  • IEC 60601-2-37 (particular safety for ultrasonic equipment)
  • IEC 61157 (acoustic output reporting)
  • NEMA UD 2 & UD 3 (acoustic output measurement and display)
  • AIUM Quality Assurance Manual, Methods for Measuring Performance, Performance Criteria (B-Mode Accuracy, Doppler Accuracy, Doppler Sensitivity)
  • ISO 10993 (biocompatibility)
  • IEC 62304 (software life cycle)
  • IEC 62366 (usability for software)

• Reported Device Performance (against these standards): The document states that the device has been tested and meets these standards. It provides specific numerical values for Global Maximum Outputs/Worst Case Setting for both the predicate device and the new device, and the new transducers compared to their comparable predicates. These values (ISPTA.3, TI, MI, IPA.3@MI Max) are within the guideline limits, demonstrating compliance with acoustic output safety.

  Table: Implicit Acceptance Criteria and Reported Performance (selected acoustic safety parameters)

  Parameter	Acceptance Criteria (within Guideline limits for medical ultrasound)	Terason uSmart3200T Plus (New System - worst case)	Terason uSmart3200T (Predicate System - worst case)
  ISPTA.3	(Implicit - must be within safe limits)	619 mW/cm² (10BP4C)	652.9 mW/cm² (4V2A)
  TI (Type TIC)	(Implicit - must be within safe limits)	4.2 (14L3)	5.8 (15L4)
  MI	(Implicit - must be within safe limits)	1.76 (15XL4)	1.78 (8EC4A)
  IPA.3@MI Max	(Implicit - must be within safe limits)	776 W/cm² (14L3)	827 W/cm² (1514)

  Table: New Transducer Performance Summary (selected acoustic safety parameters)

  Transducer	ISTPA.3 (mW/cm²)	TI	MI
  14L3 (New)	618	4.2	1.75
  10BP4 (New)	606	0.99	1.75
  15XL4 (New)	620	3.3	1.8

  (Note: The "Acceptance Criteria" for these specific values are implicit as "within guideline limits" which is the standard for 510(k) clearance for ultrasound devices, but no explicit numerical thresholds are provided in the document beyond the device's measured performance.)

• Other tests confirming acceptance:

  • Biocompatibility tests (ISO 10993 Part 5, Part 10, Part 12) for new transducers were performed and passed.
  • B-Mode Accuracy, Doppler Accuracy, and Doppler Sensitivity were evaluated per AIUM standards.
  • Software performance and regression testing were conducted per IEC 62304 and IEC 62366.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• This document is for an ultrasound hardware system with new transducers, not an AI/algorithm. Therefore, there is no patient-data based test set, sample size, or provenance in the context of an "AI/algorithm study." The testing is primarily bench-top (acoustic output, electrical safety, EMC, biocompatibility) and software performance testing.

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. As there is no patient-data based test set with ground truth established by medical experts (e.g., radiologists), this information is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is described because there is no clinical test set requiring expert consensus.

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

• No MRMC study was done. This is an ultrasound system hardware submission, not an AI/algorithm.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

• Not applicable. This pertains to an AI algorithm, which is not the subject of this 510(k). The device itself (ultrasound system) has "standalone" performance in terms of image acquisition and display, which is validated through the acoustic and image quality tests mentioned (B-Mode accuracy, Doppler accuracy/sensitivity).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the technical performance of the ultrasound system and transducers, the "ground truth" is defined by established engineering standards and physical measurements. For example, acoustic output measurements are compared against industry standards, and image quality parameters are assessed against defined metrics. Biocompatibility is tested using standardized lab procedures. There is no clinical "ground truth" (e.g., pathology, outcomes) in this submission as it's not a diagnostic AI/CAD device.

8. The sample size for the training set

• Not applicable. This document is not for an AI/machine learning algorithm, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. No training set is involved.

In summary: This 510(k) submission for the Terason uSmart3200T Plus Ultrasound System demonstrates substantial equivalence by showing compliance with established performance, safety, and electromagnetic compatibility standards, as well as biocompatibility. It is a hardware and software update to an existing device, not an AI/algorithm-driven diagnostic tool, which is why most of your requested points regarding clinical study design, readers, and ground truth are not applicable. The "study" proving the device meets criteria is a series of non-clinical, bench-top tests against recognized industry and international standards.

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