Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo 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™ ECHO/t3000 Ultrasound System with Stress Echo comprises two versions of the TERATECH Model 2000 Imaging System introduced under K051334.

The provided text is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, but does not contain information about specific performance acceptance criteria or a study proving the device meets those criteria.

Instead, the document primarily focuses on:

• Device Description: Comparing the TERASON™ Echo/t3000 to the TERATECH 2000, highlighting features like CW Doppler, ECG Trigger, Tissue Doppler, LV Dyssynchrony Assessment, and Stress Echo.
• Intended Use: A detailed table outlining clinical applications and modes of operation for various transducers (AcuNav 8F & 10F, 4V2, UST-534, V5Ms).
• Substantial Equivalence: Stating that the Stress Echo function is substantially equivalent to the Acuson Cypress Ultrasound, and that the device will be marketed with previously cleared transducers from Acuson and Aloka.
• FDA Clearance Letter: Confirming the FDA's review and determination of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text. The document is an FDA 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed predicate devices rather than detailing independent performance studies against specific acceptance criteria.

Ask a specific question about this device

The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

The provided text is a 510(k) summary for the Siemens Medical Solutions Siemens P50™ Ultrasound System. This document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies of its own.

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

• A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the P50 system itself, as it relies on the predicate devices.
• Sample size used for the test set and the data provenance: No new clinical test sets are described for performance evaluation.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no new test set is described.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an ultrasound imaging system, not an AI algorithm in the traditional sense, and its primary function involves human operation.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the context of this 510(k).
• How the ground truth for the training set was established: Not applicable.

Explanation of the Device's Approval Approach based on the provided text:

The Siemens P50™ Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices (Teratech Model 2000 Imaging System, Teratech Model 8C4 Endocavity Smart Probe, etc.).

Key arguments for substantial equivalence:

• Identicality to predicate devices: "The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section." (Page 2)
• Modes of operation: "It is equivalent in modes of operation." (Page 2)
• Intended clinical applications: "and intended for the same clinical applications." (Page 2)
• Hardware and Software: The hardware and software are explicitly stated as "No change" compared to the Teratech 2000 specified in K051334. (Page 2)
• Transducers: The submission details specific transducers intended for use with the ACUSON P50, and their intended uses (clinical application and mode of operation) are largely marked as "P" (previously cleared by FDA) for the various modes (B, M, PWD, CWD, Color Doppler, Combination Modes, and Harmonic Imaging). For the 4V2 Phased Array transducer, K063085 is referenced; for the 7L3 Linear Array, K042055 is referenced; for the 12HL7 Hockeystick Linear Array and 12L5 Linear Array, K051334 is referenced; and for the AuxCW 2MHz Pedof, K063085 is referenced. This indicates that the performance of these transducers for their stated clinical applications has already been established and cleared by the FDA under their respective 510(k) numbers.

In essence, the device meets regulatory requirements by demonstrating that it is as safe and effective as existing legally marketed devices, primarily by being identical or having changes that do not raise new questions of safety or effectiveness. No new, independent performance study validating specific acceptance criteria for the P50 system itself is detailed in this 510(k) summary, as its performance is effectively "inherited" from its predicate devices.

Ask a specific question about this device