(344 days)
The SentEP system is intended for use as a medical imaging system that allows the review, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.
The SentEP system is an imaging system intended to be used as an adjunct product to assist the clinician in visualization of the heart anatomy during cardiac catheter mapping and ablation procedures. Images are imported from an EAMS (electroanatomic mapping system) and displayed through the SentEP system. As a result, users can view both the 2D EAMS display monitor and the 3D SentEP system display at the same time.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Metric) | Target Performance | Reported Device Performance |
|---|---|---|
| Navigational Capability (Time to 5 locations) | Within allocated time (60s per location) | The study evaluated "the ability to navigate to 5 locations within allocated time (60s per location)" comparing the SentEP system to the EAMS system. The comparison of performance data supports the conclusion that the SentEP system "was found to have a safety and effectiveness profile that is similar to the legally marketed EAMS system," implying it met this criterion. Explicit pass/fail rates or average times are not provided, but the statement suggests successful navigation within the time limit. |
| Point Location Accuracy | Not explicitly stated as a target, evaluated for comparison | The study evaluated "point location accuracy" comparing the SentEP system to the EAMS system. The conclusion that the SentEP system "was found to have a safety and effectiveness profile that is similar to the legally marketed EAMS system" suggests its accuracy was comparable and acceptable. Specific quantitative accuracy metrics (e.g., mm deviation) are not provided. |
| Usability/User Comfort | Positive Physician Exit Survey responses | The study assessed "the usability of the SentEP system by assessing the user comfort of the device" through "Physician Exit Survey responses." The overall conclusion about similar safety and effectiveness profile implies positive feedback and acceptable comfort levels. |
| Safety (Adverse Events) | No adverse events | "No adverse events were reported during this study." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 16 pediatric EP patients.
- Data Provenance:
- Country of Origin: United States.
- Study Design: Prospective, acute, single-center study.
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)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. The study refers to "the operator" (an Electrophysiologist, EP) performing procedures and navigating to intended targets, implying that the EP's actions and outcomes (time to target, point location) were the basis of evaluation. Since it's a navigational/visualization aid, the ground truth is likely based on the actual patient anatomy as confirmed by the EAMS system and the EP's clinical judgment during the procedure. The study evaluates the SentEP system against the EAMS system and the operator's ability to use it.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention a specific adjudication method like 2+1 or 3+1. The study design sounds more like a direct comparison or evaluation where the operator's performance with the SentEP system (in conjunction with EAMS) was measured against established clinical targets (navigating to 5 locations within 60s). Because it's an intraprocedural visualization aid, the "ground truth" for navigation and location accuracy is likely inherent in the real-time clinical context and the EAMS data itself, rather than a separate expert review process for each case.
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
The study was not a typical MRMC comparative effectiveness study in the sense of comparing performance with vs. without AI assistance for diagnostic accuracy. It was a usability and performance study evaluating the SentEP system when used by an operator alongside the traditional EAMS system. The study compared "the navigational capability of the SentEP system when compared to the EAMS system" and usability. It does not provide an effect size on how much human readers (operators) improve with SentEP vs. without SentEP because SentEP is an additional visualization modality and was used in conjunction with the EAMS, not as a replacement or direct comparison of diagnostic effectiveness. The evaluation was about whether the combination (EAMS + SentEP) was comparable in performance and safe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. The SentEP system is described as a "visualization modality to assist the clinician" and "does not deliver therapy, nor does it intervene with therapy." It is used with a human operator (Electrophysiologist) who interacts with the data, making it inherently a human-in-the-loop system. The clinical study specifically evaluated "SentEP system usability and performance during EP procedures" by an "operator."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the clinical study was based on:
- Navigational targets: Defined locations within the heart during EP procedures.
- Time allocation: 60 seconds per location, implying a time-based metric for successful navigation.
- Point location accuracy: The accuracy of reaching or identifying specific points, likely verified against the EAMS system data and the EP's procedural goals.
- User feedback: Physician Exit Survey responses for usability and comfort.
Essentially, the "ground truth" involved the actual anatomical and electroanatomic data provided by the EAMS system, combined with the real-time assessment of navigation and target achievement by the performing Electrophysiologist within the clinical procedure.
8. The sample size for the training set
The document does not provide information about the sample size for the training set. The clinical study described is for validation purposes, not for training the algorithm. As the device is primarily a visualization and interaction tool for existing electroanatomic data, it's possible that a traditional "training set" in the machine learning sense is not applicable or not disclosed as part of the regulatory submission summary provided.
9. How the ground truth for the training set was established
Since no information regarding a training set is provided, how its ground truth was established is also not detailed in this document.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).