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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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(28 days)
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.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| General Safety | IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety. | The ProSound C3/C3cv systems have been "tested for compliance" with this standard, with specific Intertek Test Record Numbers (e.g., 3157931BOX-001B for C3, 3157931BOX-005A for C3cv) referenced as proof. This implies successful completion of the tests and meeting the requirements, but no quantitative performance data is provided here. |
| Electrical Systems Safety | IEC 60601-1-1: Medical Electrical Equipment Part 1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems. | "Tested for compliance" with specific Intertek Project references (e.g., 9157933BOX-002A for C3, 9157933BOX-002B for C3cv). Implies successful completion. |
| IEC 60601-1-4 (2000): Collateral Standard: Safety Requirements for Medical Electrical Systems. (Note: This is a duplicate or very similar standard to IEC 60601-1-1 listed directly above it in the original text, but listed separately) | "Tested for compliance" with specific Intertek Project references (e.g., 9157933BOX-003A for C3, 9157933BOX-003B for C3cv). Implies successful completion. | |
| Ultrasonic Safety & Performance | IEC 60601-2-37 / EN60601-2-37: Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. | "Tested for compliance" for various transducer models, with specific Intertek Report Numbers referenced for each (e.g., UST-TL01, UST-TL02, UST-TC04, UST-TC05, UST-TC06, UST-TL07 for C3; UST-TL01, UST-TL02, UST-TS03, UST-TC04, UST-TC06, UST-TI09 for C3cv). This indicates that the acoustic output and other safety aspects of the transducers meet the specified requirements. No specific quantitative performance data is provided here. |
| Acoustic Output Display | NEMA UD 3: Acoustic Output Display. | User Guide (16-5001) for ProSound C3/C3cv is referenced, indicating compliance with NEMA UD 3 for acoustic output display. This is a standard for how acoustic output is presented to the user, not performance itself. |
| Biocompatibility | ISO 10993 Part 5 and Part 10. | "Biocompatibility reports for all transducers included in this submission" are mentioned, indicating compliance. |
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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(11 days)
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.
The provided document is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It outlines the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.
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(17 days)
The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system.
The provided text is a 510(k) summary for TERATECH Model 810C4, 810L4, and 10LAP4 Probes. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
The document discusses:
- Device Name: TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
- Predicate Devices: Philips LI9-5, Philips CT8-4, Philips LAP L9-5, and TERATECH 10V5 (along with their associated 510(k) clearances).
- Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific indications are tabulated for each probe model across various clinical applications and modes of operation (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Combined Modes, Other).
- Device Description: Technical specifications (Frequency, # Elements, Array type, Pitch, Elevation width, Geometric focus, Azimuth radius, Azimuth length) for each probe model.
- Basis for Substantial Equivalence: The subject devices are claimed to be "identical in mechanical design and materials to the respective Philips," and intended for the same clinical applications. The FDA's letter confirms substantial equivalence.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria and performance studies because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, which does not typically include detailed performance study results against pre-defined acceptance criteria in the way a clinical trial or a more rigorous performance study might.
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