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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.

Ask a specific question about this device

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.

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: 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 uSmart3300 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-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

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 host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.

The provided text describes the Terason uSmart3300 Ultrasound System and its associated transducers, focusing on demonstrating substantial equivalence to predicate devices for FDA 510(k) clearance. The study primarily involves comparing the device's technical characteristics and safety performance against established standards and predicates, rather than a clinical efficacy study with human readers or specific performance metrics like sensitivity/specificity for a diagnostic task.

Here's an analysis of the requested information based on the provided text:

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

The acceptance criteria are implicitly defined by compliance with various medical device standards and demonstrating equivalence to predicate devices, particularly regarding safety and intended use. Performance is reported in terms of meeting these standards and having similar specifications to the predicates.

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 primarily describes a technical and performance comparison against predicate devices and mandated standards, not a clinical study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "tests" mentioned are for technical and safety compliance (e.g., acoustic output, electrical safety, biocompatibility).

• Test Set Sample Size: Not applicable in the context of a clinical test set for AI/algorithm performance. The "tests" refer to engineering and regulatory compliance assessments.
• Data Provenance: Not applicable. The "data" comes from engineering measurements and compliance testing, not patient studies.

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 is not applicable. The submission focuses on device equivalence and safety/performance standards, not on evaluating the diagnostic accuracy of the device against expert-established ground truth in a clinical setting.

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

This is not applicable, as there is no clinical test set requiring expert 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

This is not applicable. This document is for a medical ultrasound system (hardware and associated transducers), not an AI/algorithm-driven diagnostic aid. Therefore, no MRMC study or AI assistance evaluation would be conducted for this type of submission.

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

This is not applicable. This submission is for an ultrasound imaging system, which is a diagnostic tool operated by a human, not a standalone algorithm.

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

This is not applicable in the context of diagnostic accuracy. The "ground truth" here refers to the performance specifications and safety limits defined by recognized medical device standards (e.g., IEC, NEMA) and the established performance of predicate devices.

8. The sample size for the training set

This is not applicable. There is no mention of a training set as this is not an AI/machine learning device submission.

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

This is not applicable. There is no training set for this device.

Ask a specific question about this device

Ask a specific question about this device

The Teratech Corporation Terason™ uSmart3400 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, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

The Terason™ uSmart3400 ultrasound system is a portable, full-featured ultrasound system used to acquire and display high-resolution, real-time ultrasound data using multiple image modes. This system contains a proprietary ultrasound engine (identical to the predicate device Terason t3200 ultrasound system) for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the host singleboard computer (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. Three transducers (15L4, 5C2A, 4V2A) connect to the system using the identical connector to the predicate device, Terason t3200.

The Terason™ uSmart3400 ultrasound EBook weighs 14.6 pounds and has a 15.3" backlit screen. The system dimensions (3.5"(H) x 15.3"(W) x 15.6"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the EBook) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for charging). 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 information describes a 510(k) summary for the Terason™ uSmart3400 Ultrasound System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device to existing cleared devices rather than providing detailed clinical study results with specific performance metrics against defined acceptance criteria in the manner one might find for a novel AI-powered diagnostic device.

Therefore, the following information is extracted and presented based on the context of this 510(k) summary. Acceptance criteria and performance are primarily discussed in terms of substantial equivalence to predicate devices through technical comparisons and compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness. The "reported device performance" is essentially the comparison of the uSmart3400 and its transducers against the predicate devices across various technical and functional aspects.

Study Details:

Detailed analysis of "studies" within the context of this 510(k) summary:

It's crucial to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, rather than conducting new, large-scale clinical trials that would define novel acceptance criteria and extensive performance metrics. The "studies" referenced are conformity assessments against recognized standards and technical comparisons.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation studies for this 510(k). The "testing" involves technical compliance to standards and comparison of specifications.
• Data Provenance: The data primarily comes from bench testing, engineering analysis, and comparisons to specifications of previously cleared devices.
  • Acoustic output testing was performed per IEC60601-2-37.
  • Biocompatibility testing per ISO 10993 Parts 5 and 10.
  • Electrical and EMC testing per IEC 60601 series and CISPR11.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The ground truth here is the adherence to recognized medical device standards and the established safety and performance characteristics of the predicate devices. Experts involved would be engineers, regulatory specialists, and standard body members who define these compliance requirements, not clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set:

• Not applicable. There is no clinical test set requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is typically conducted for AI-powered diagnostic devices to assess the comparative performance of human readers with and without AI assistance. This 510(k) is for a conventional ultrasound system and does not involve AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This is not an AI algorithm.

7. Type of Ground Truth Used:

• Engineering and Regulatory Standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993, CISPR11): These standards define the "ground truth" for safety, electrical performance, acoustic output, and biocompatibility.
• Predicate Device Specifications and Performance: The performance and safety of the previously cleared predicate devices serve as the benchmark for "ground truth" for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Ask a specific question about this device

The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) 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, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Terason uSmart3200T ultrasound system is a portable tablet style full feature, general purpose, and 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 version of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers (15L4, 16HL7, and 8EC4A) with the no change to tablet style computer form factor.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date of May 28, 2013 as described in the 510(k) submission (K131209). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. This data are then transferred to the tablet 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 medicalgrade 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 document is a 510(k) premarket notification for the Terason uSmart3200T and BenQ UP200 Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested in terms of acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert ground truth establishment, or training set details.

The submission primarily lists the device's technical specifications and how they compare to predicate devices. The "Non Clinical Tests" section refers to compliance with various electrical safety, usability, and acoustic output standards, which serve as the "acceptance criteria" for regulatory clearance in this context. However, these are performance standards, not clinical performance metrics.

Here's a summary of the available information based on your request, highlighting what is not present in this type of regulatory document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally compliance with international and national standards for medical devices, particularly regarding safety and technological characteristics. The "reported device performance" is demonstrated through this compliance and the assertion of substantial equivalence to predicate devices which have already met such criteria.

2. Sample size used for the test set and the data provenance

This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The tests performed are non-clinical compliance tests against established safety and electrical standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not pertain to a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring 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 is a 510(k) submission for a diagnostic ultrasound system and transducers, which does not involve AI or comparative effectiveness studies with human readers.

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

Not applicable, as this device does not involve a standalone algorithm for performance evaluation.

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

Not applicable, as no clinical ground truth is established or used in this submission. The "ground truth" here is compliance with engineering and safety standards.

8. The sample size for the training set

Not applicable, as this document does not describe a machine learning model or training set.

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

Not applicable, for the same reason as above.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence primarily by:

• Listing the device's technical characteristics and comparing them directly to previously cleared predicate devices (Terason uSmart3200T (K131209), Terason™ t3000 (K112953), Terason™ T3200 (K110020)).
• Highlighting that the modifications (addition of three transducers and software updates) do not alter the fundamental technological characteristics or intended use.
• Providing evidence of compliance with a comprehensive set of non-clinical safety, electrical, usability, and acoustic output standards.

The "study" that proves the device meets the "acceptance criteria" here consists of these non-clinical tests and direct comparisons to predicate devices, rather than clinical performance studies with patient data. The regulatory body (FDA) reviews these submissions to ensure the new device is as safe and effective as existing legally marketed devices, without requiring new clinical efficacy data if substantial equivalence is adequately demonstrated.

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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: 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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The Teratech Corporation Terason t3000™ 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 subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

The Terason t3000 is a modified version of the Echo/t3000 Ultrasound System. The modifications include the addition of 6 new transducers (12L5A, 4V2A, 12HL7, 8EC4A, 8EC4V, and 10V5S) and improved needle guidance technology components developed by SOMA Access Systems LLC and integrated into the Terason 10V5S transducer.

The design and construction of the Terason t3000 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The differences between the Terason t3000 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:

• Six new transducers have been added to the system. The software has been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
• An improved needle guidance technology is provided with the 10V5S transducer. An array of Hall Effect sensors with a data capture board is integrated into the body of the 10V5S transducer. The sensors track the position of the needle by sensing and determining the position of a magnet located on the needle. This information is transferred through the Terason engine to the application software that generates a graphic overlay upon the ultrasound image showing the position of the tip of the needle to the ultrasound acquired target. The needle tip is a virtual highlight, providing the user with a real time position update, making it easier to insert the needle in the intended target in the first attempt. This improvement is intended to result in significant reductions of multiple insertions, adjustments of needle position during insertions and resultant trauma. infections and ancillary complications from less adequate methods of needle guidance. The needle guidance software component that produces the graphic overlay of needle position is developed by Soma Access Systems LLC of Greenville, S.C. and integrated into the Terason t3000 ultrasound software application.

The provided 510(k) summary for the Terason t3000™ Ultrasound System primarily focuses on demonstrating substantial equivalence to a predicate device (Terason™ Echo/t3000 Ultrasound System, K080234), particularly regarding the addition of new transducers and improved needle guidance technology. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic accuracy or clinical performance study for image interpretation by an algorithm.

The studies mentioned are primarily non-clinical electrical, acoustic emission, and biocompatibility tests intended to ensure safety and compliance with recognized standards.

Here's an analysis based on the information provided, highlighting what is missing or not applicable within the context of a diagnostic AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided for diagnostic performance (e.g., sensitivity, specificity, accuracy) related to an AI algorithm for image interpretation. The document lists compliance with various IEC and NEMA standards for safety and acoustic output, which are technical acceptance criteria for the hardware itself.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of a diagnostic accuracy study for an AI algorithm interpreting ultrasound images. The document mentions non-clinical technical tests, which do not typically involve patient-derived test sets in this manner. The "needle guidance technology" is an assistive tool, not a diagnostic algorithm interpreting images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The studies described are non-clinical safety and performance tests of the ultrasound system and its components (transducers, needle guidance system), not diagnostic accuracy studies requiring expert-adjudicated ground truth for image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic accuracy test set or associated adjudication 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

No MRMC study is mentioned. The improved needle guidance technology is described as an assistive tool, but no formal comparative effectiveness study quantifying human improvement with this assistance is detailed in this summary.

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

No standalone algorithm performance study is mentioned for image interpretation. The "needle guidance technology components" integrated into the 10V5S transducer provide a graphic overlay, which is an assistive feature, not a standalone diagnostic algorithm.

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

Not applicable in this document for the reasons stated above. Ground truth for safety and acoustic output tests would typically involve physical measurements and comparisons to engineering specifications or regulatory limits.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this device is an ultrasound system with enhanced needle guidance, not a machine learning-based diagnostic algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no mention of a training set.

Conclusion:

This 510(k) summary is for a traditional diagnostic ultrasound system with added transducers and a novel needle guidance feature. The "acceptance criteria" and "studies" detailed are primarily for demonstrating the safety and technical performance of the hardware (ultrasound system and transducers) and its compliance with established regulatory standards (e.g., IEC, ISO, NEMA). It does not contain the type of AI-specific or diagnostic accuracy information (such as sensitivity, specificity, reader studies, or training/test set details) that would be relevant for a device utilizing artificial intelligence to interpret medical images or make diagnostic assessments. The needle guidance system is presented as an aid to physical procedures, not as an AI-powered diagnostic tool.

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The Aloka ProSound C3 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 Aloka ProSound C3cv 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 subject-modified device 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/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

The subject-modified device 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/OB; Andominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pedintria; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrects | and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

The ProSound C3 is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish), a slight modification of Transmit circuitry, providing a slightly different acoustic profile and the introduction of a spatial compounding feature called OMNIBeam.

The design and construction of the ProSound C3 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The ProSound C3cv is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish) and the introduction of a spatial compounding feature called OmniBeam.

The design and construction of the ProSound C3cv is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The provided text describes modifications to an ultrasound system (Aloka ProSound C3 and C3cv) and its transducers, and references various non-clinical tests to demonstrate compliance with general safety and performance standards. However, it does not contain information about acceptance criteria for specific imaging performance metrics, nor does it describe studies with sample sizes, expert ground truth, or comparative effectiveness with human readers using AI.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. This is often achieved through non-clinical testing against recognized standards rather than extensive clinical performance studies as would be required for novel devices or AI systems making diagnostic claims.

Therefore, most of the requested information cannot be extracted from this document because such studies were not conducted or described in this regulatory filing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report specific device performance metrics in comparison to such criteria. Instead, compliance is demonstrated through adherence to recognized international and national standards for medical electrical equipment and ultrasonic devices.

Missing Information (Not found in the provided document):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information on test sets (beyond compliance testing) for clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test sets with ground truth are described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. AI assistance is not mentioned as a feature of this ultrasound system. The "OMNIBeam" feature is spatial compounding, which is an image processing technique, not an AI diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a diagnostic ultrasound system (hardware and associated software), not a standalone diagnostic algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" demonstrated is compliance with engineering and safety standards.
• The sample size for the training set: Not applicable. The document does not describe an AI/machine learning component that would require a training set. The software modifications are for foreign language support and spatial compounding (OMNIBeam).
• How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with established medical device safety and performance standards for an ultrasound system and its transducers. This type of regulatory submission does not typically include detailed clinical performance studies, ground truth establishment, or AI-specific assessment criteria as would be expected for novel diagnostic algorithms. The modifications primarily concern product labeling, foreign language support, a minor transmit circuitry change, and the addition of a spatial compounding feature (OMNIBeam), all of which are assessed for safety and basic functionality rather than intricate diagnostic performance studies with expert ground truth.

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