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The Teratech Corporation Terason™ t3200 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, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Terason™ t3200 is a modified version of the Echo/t3000 Ultrasound System. The modifications include improved transducer acoustic arrays, an improvement in the ultrasound beam forming engine to improve the bandwidth of the receive signal processing capability and improvements in the software for workflow and ease of use of the system.

This is a 510(k) premarket notification for the Terason™ t3200 Ultrasound System, seeking clearance to market the device. This submission does not contain information about software as a medical device (SaMD) or AI/ML components for image analysis, diagnosis, or treatment planning. Therefore, most of the requested information regarding acceptance criteria and studies that prove a device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Terason™ Echo/t3000 Ultrasound System (K080234)) through hardware and software modifications, and compliance with general safety and performance standards.

Here's a breakdown of the relevant information present in the document in response to your prompts:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical accuracy or diagnostic performance metrics for AI/ML.

However, it lists compliance with several international and national standards as evidence of device safety and basic performance:

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

Not applicable. This document does not describe a clinical performance study with a test set of patient data for evaluating an AI/ML algorithm. The tests conducted are primarily engineering and compliance tests.

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. No ground truth establishment for a diagnostic test set is described.

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

Not applicable. No adjudication of a test set 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. No MRMC study or AI assistance is mentioned in this submission.

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

Not applicable. There is no mention of a standalone algorithm in this submission. The device is an ultrasound system.

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

Not applicable. No ground truth for diagnostic performance is mentioned. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the standards themselves.

8. The sample size for the training set

Not applicable. This document describes an ultrasound system, not an AI/ML model for which a training set would be relevant.

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

Not applicable. As above, this document does not concern an AI/ML model.

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