Search Results

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 SonoSite Edge Ultrasound System 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 - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.

The provided 510(k) summary for the SonoSite Edge Ultrasound System (K133454) states that clinical studies were not required to support the determination of substantial equivalence. The submission relies on non-clinical tests and a comparison of technological characteristics to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly mentioned in the provided text as they would typically stem from a clinical study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed for this 510(k) submission, there are no specific performance criteria or reported performance results in the context of a clinical evaluation. The document focuses on compliance with established safety standards and equivalence to predicate devices.

The "acceptance criteria" here are implicitly the existing standards and the characteristics of the predicate devices. The "reported device performance" is that it conforms to these standards and shares similar features, functionality, and performance parameters with its predicates.

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

Not applicable, as no clinical study was performed. The evaluation relied on non-clinical testing and comparison to predicate devices, which implies leveraging existing data and regulatory clearances from those predicate devices.

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

Not applicable, as no clinical study and associated ground truth establishment for a test set were conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study was performed.

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, as no clinical study, particularly an MRMC study, comparing AI assistance to human readers was performed. The device described is a general-purpose ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable, as the device is a diagnostic ultrasound system, which inherently involves a human operator (qualified physician) for its intended use. It is not an AI algorithm operating autonomously.

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

Not applicable, as no clinical study was performed requiring the establishment of ground truth for diagnostic accuracy. For non-clinical aspects like safety and performance, the "ground truth" is adherence to recognized standards and engineering specifications.

8. The sample size for the training set:

Not applicable, as no clinical study was performed, and the device is not described as utilizing a machine learning algorithm that would require a training set of patient data.

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

Not applicable, as no clinical study was performed and no machine learning training set is mentioned for the device.

Ask a specific question about this device

The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.

The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record. Qualified ultrasound imaging units include the SonoSite M-Turbo and SonoSite M-MSK, (configuration part numbers L05323 and L05600, respectively).

This document describes the 510(k) submission for the Navigator™ Delivery System (Navigator DS) with added image integration capability. The submission asserts that this modification does not introduce new safety or effectiveness concerns, and thus, a full clinical evaluation was not required. The study focuses on demonstrating that the added image integration feature does not negatively impact the device's original safety and performance.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set for evaluating an algorithm's performance on patient data. Instead, it appears the "test set" refers to the device itself and its interaction with the added feature. Therefore, there is no mention of sample size for patient data or data provenance (e.g., country of origin, retrospective/prospective). The testing described focuses on the device's engineering performance.

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

Not applicable. This is an engineering and functional performance evaluation of a device modification, not an assessment of an AI's diagnostic or predictive capabilities requiring expert-established ground truth on medical data.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a human-in-the-loop diagnostic task requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved." This indicates the focus was not on comparing human reader performance with or without AI assistance but rather on the safety and functionality of the device with a new feature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary focus of this submission is a device modification. The "image integration capability" described is about displaying treatment information from the Navigator DS on an ultrasound screen and printing ultrasound images on patient treatment records. It does not appear to be an AI algorithm with standalone diagnostic or predictive performance. Therefore, a standalone algorithm performance study as typically understood for AI-driven devices was not conducted. The "software validation" mentioned would cover the functionality of this integration.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context refers to the expected functional performance and safety of the device. This was established through:

• Software Validation: Ensuring the software for image integration works as intended.
• Electrical Testing: Verifying safe electrical operation of connected devices.
• Simulated Use Testing: Confirming the device performs safely and effectively in simulated scenarios.
• Safety Case and Hazard Analysis: Identifying potential risks and ensuring mitigation measures are effective.

These are engineering and safety benchmarks, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The described image integration is a functional modification to a device and does not involve an AI algorithm that would typically require a "training set" of medical data.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device