(134 days)
The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.
The ultrasound guidance system is used during diagnostic or therapeutic procedures to assist the clinician in placing an interventional device in a targeted anatomical location. The quidance system consists of a quide, gauge inserts, and may include a bracket. The guide attaches to the OEM ultrasound transducer via a VerzaLink™ locating feature either on the customized bracket (Figure 1) or on the OEM ultrasound transducer housing (Figure 2). The guide is secured to the locating feature using a locking mechanism. The angle of the quide adjusts within a 37° range by moving the angle selector grip proximally or distally on the quide. The angle is secured into place at the desired position using a locking mechanism. The guide receives the gauge inserts. The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. Rotation of a quick-release tab on the gauge insert enables the guide and OEM ultrasound transducer to be removed while leaving the interventional instrument in place. The guide and gauge inserts are provided sterile, and are intended for single-use. The bracket is provided non-sterile and is reusable.
The provided text describes a 510(k) premarket notification for the "Verza™ Guidance System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a clinical study with detailed performance metrics and ground truth establishment for an AI algorithm.
Therefore, many of the requested elements for an AI study (like sample size for test/training sets, ground truth details, expert qualifications, or MRMC studies) are not applicable or extractable from this type of document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical testing to confirm the safety and effectiveness of design modifications. The acceptance criteria were implicit in demonstrating that these modifications did not diminish safety and effectiveness. The reported performance is a statement of compliance rather than quantitative metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1) Attachment of the guide to the locating feature on the transducer bracket or on the OEM ultrasound transducer housing: The guide must securely attach and function as intended. | "Testing relating to 1) attachment of the guide to the locating feature on the transducer bracket or on the OEM ultrasound transducer housing...met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." Specifically, the guide is secured to the locating feature using a locking mechanism. The proposed guidance system including a bracket was validated with the GE C1-6-D transducer. |
| 2) Expanded range of gauge inserts: The expanded range of gauge inserts (12F to 25G) must function correctly and safely. | "Testing relating to...2) an expanded range of gauge inserts...met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. |
| 3) Increased guide angle range: The increased guide angle range (37°) must function correctly and safely, allowing precise instrument placement. | "Testing relating to...3) an increased guide angle range met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." The angle of the guide adjusts within a 37° range and is secured into place with a locking mechanism. |
| Biocompatibility: Patient-contacting materials must meet established biocompatibility standards. | "Biocompatibility testing was completed for patient-contacting materials according to ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F756." (Conclusion: Met standards) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The testing described is non-clinical/engineering verification of device function and safety features, not a clinical study on a patient cohort or a dataset for an AI algorithm.
- Data Provenance: Not applicable in the context of an AI study. The testing refers to physical device functionality checks in a lab setting. "Clinical images were provided with the submission; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to the test performance data to show that the complete ultrasound guidance system works as intended." This suggests some informal use of clinical images for demonstration, but not as a formal test set for performance evaluation in the AI sense.
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. This is a physical device, not an AI algorithm requiring expert-annotated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a physical device, not an AI algorithm requiring adjudication of ground truth labels.
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 physical device, not an AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical guidance system, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device would be its mechanical and material properties meeting specifications and performing its intended function (guidance of instruments) in simulated or actual usage scenarios.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.