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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

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.

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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.

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.

Ask a specific question about this device

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: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Terason™ uSmarl3200T ultrasound system is equivalent to the previously cleared version of the t3200 and t3000 Ultrasound Systems described in the following 510(k) submissions (K110020 and K112953). 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 (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and 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 t3200. Optional accessories include a cart and printer.

The provided document is a 510(k) Summary for the Terason™ uSmart3200T Ultrasound System, detailing its substantial equivalence to previously cleared devices. It focuses on regulatory compliance, safety, and performance characteristics rather than clinical study results establishing diagnostic accuracy against a ground truth.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy metrics). The document refers to compliance with safety and performance standards (e.g., IEC 60601-1) but not clinical performance acceptance criteria like sensitivity, specificity, or AUC against a ground truth.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

However, based on the document, I can provide the following relevant information regarding the device's acceptance criteria and the study that proves its compliance with regulatory standards:

The device's acceptance criteria are primarily defined by compliance with established international and national standards for medical electrical equipment, including safety, usability, electromagnetic compatibility, and acoustic output. The "study" proving the device meets these criteria consists of specific non-clinical tests and reports generated by accredited testing laboratories (Intertek).

1. A table of acceptance criteria and the reported device performance (focused on technical compliance):

Important Note: This document describes a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a previously cleared device. It does not typically involve new clinical efficacy studies with ground truth establishment in the way that, for example, a novel diagnostic AI algorithm would. The "performance" here refers to meeting established safety and performance standards for ultrasound devices, and demonstrating that changes from predicate devices (e.g., changing from laptop to tablet) do not raise new safety or effectiveness concerns.

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