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510(k) Data Aggregation
(122 days)
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.
| Acceptance Criterion (Type) | Reported Device Performance |
|---|---|
| Electrical Safety | Compliance to IEC 60601-1, IEC 60601-1-1, IEC60601-1-4 (as per Intertek Test Record Numbers 9157933BOX-001A, -001B, -001C) |
| Acoustic Output | Compliance to IEC 60601-2-37 / EN60601-2-37 for all new transducers (as per specific Intertek Report Numbers for each transducer) and NEMA UD 3 Acoustic Output Display (as per User Guide) |
| Biocompatibility | Compliance to ISO 10993 Part 5 and Part 10 (as per biocompatibility reports for the six new transducers) |
| Needle Guidance Performance | "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." (This is a description of intended benefit, not a quantified performance metric or acceptance criterion.) |
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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(17 days)
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:
| Acceptance Criteria Category | Standard / Test | Reported Device Performance (Compliance) |
|---|---|---|
| Safety | IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety. | Compliant (Intertek Test Record Number 100116897BOX-003) |
| Usability | IEC 62366, Medical Devices: Application of usability engineering to medical devices. | Compliant (Intertek Project: 100116897BOX-005) |
| IEC60601-1-6, Medical Electrical Equipment Part 1-6: General requirements for safety- Collateral standard: Usability | Compliant (Intertek Project: 100116897BOX-006) | |
| Electromagnetic Compatibility | IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2; General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests | Compliant (Intertek Test Record Number, 100116897BOX-013, 100116897BOX-010) |
| Particular Safety for Ultrasonic Equipment | IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. | Compliant for Transducer Models 6C1, 15L4, and 16HL7 (Intertek reports listed) |
| Acoustic Output Display | NEMA UD 3 Acoustic Output Display Terason t3200 Ultrasound System User Guide (16-3033) | Compliant (User Guide provided) |
| Biocompatibility | ISO 10993 Part 5 and Part 10 (for all transducers) | Compliant (Biocompatibility reports provided in attachments M-O) |
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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