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CommandEP is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. CommandEP is designed as an additional visualization modality to assist the clinician. CommandEP indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.

The SentiAR CommandEP device is a medical imaging system which allows for the review, analysis, communication, and media interchange of multi-dimensional digital images. CommandEP HMD provides a real-time, three-dimensional (3D) visualization of electroanatomic mapping system (EAMS) data (the Mixed Reality (MXR) EAMS Visualization). CommandEP is intended to be used as an adjunct device to assist the clinician in visualization of the cardiac electrophysiology procedures.

Real-time multi-dimensional images are received from an Electroanatomic Mapping System (EAMS) by the touchscreen, all-in-one computer (the Model DPC02 Data Manager PC) and wirelessly transmitted to up to five (5) Head Mounted Displays (the Model HMD02 CommandEP HMD). Additional HMDs may be allocated to facilitate charging and device management. The EAMS is directly connected to the CommandEP by a wired network cable. The CommandEP Data Manager PC communicates with the CommandEP HMDs through a dedicated, encrypted Wi-Fi network provided by the Data Manager PC.

Clinician users view the MXR EAMS Visualization in stereoscopic 3D using optical see-through (OST) HMDs and manipulate the MXR EAMS Visualization using hands-free gaze-dwell controls. The OST display enables clinicians to view both the conventional EAMS display and the CommandEP MXR EAMS Visualization during the procedure. The hands-free controls enable clinicians to control the device without breaking sterility and may also reduce the need to verbalize commands to a non-sterile EAMS technician.

CommandEP allows a clinician user to modify the personal view of data, but does not deliver therapy, intervene with therapy, assist the clinician with therapeutic decisions, or otherwise affect the performance of any other medical device.

CommandEP also provides a shared view function which allows observers or supporting staff to view the cardiac electroanatomic data, with the notated perspective of a selected HMD user, on an either 1) an HMD or 2) a conventional PC display provided by the Data Manager PC (the Spectator Display) to facilitate team communication.

The intended physician user of the CommandEP device is an electrophysiologist. The electrophysiologist performs procedures in a cardiac electrophysiology laboratory, which is a sterile professional healthcare environment. All components of the CommandEP device are non-patient contacting device and are provided non-sterile.

The provided text does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria. It is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions. However, based on the provided text, I can infer some general information:

• No clinical testing was required: This indicates that the substantial equivalence was based on non-clinical performance and technological comparisons, not a clinical study involving human subjects or AI-assisted human reader performance.
• Focus on Substantial Equivalence: The document repeatedly emphasizes that the device is "as safe and effective as the legally marketed predicate device" and "raises no new questions of safety or effectiveness." This is the primary "proof" for 510(k) clearance.
• Acceptance Criteria for Non-Clinical Tests: The document states that "The test methods and acceptance criteria were equivalent to the predicate device in support of the intended use." While the specific criteria aren't detailed, it implies that the device had to perform comparably to the predicate in areas like biocompatibility, electromagnetic compatibility, wireless capability, electrical, mechanical, and thermal safety, and software specifications.

Here's what can be extracted directly or indirectly from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

(Note: The document states "test methods and acceptance criteria were equivalent to the predicate device," but does not list the specific numerical or qualitative acceptance criteria themselves. The "reported device performance" is a general statement of compliance rather than specific metrics.)

2. Sample sized used for the test set and the data provenance:

• The document does not mention "test sets" in the context of clinical data. The testing described is non-clinical performance verification and validation. No sample sizes for data sets are provided.
• Data provenance is not applicable here as no patient data or clinical study data is referenced.

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. No clinical test set or ground truth established by experts is mentioned for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set or adjudication process is mentioned.

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 comparative effectiveness study was done. The document explicitly states: "No clinical testing was required to develop evidence of substantial equivalence to the predicate device." The device is intended as an "additional visualization modality to assist the clinician," but its impact on human reader performance was not assessed in a clinical study for this submission.

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

• Yes, in a sense. The "performance testing" mentioned (e.g., software, electrical, optical properties) would be standalone testing of the device's functionality. However, it's not "algorithm only" in the context of diagnostic performance as would be seen for an AI diagnostic device. The device is a "medical imaging system" for visualization rather than an autonomous diagnostic algorithm.

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

• Not applicable in the context of clinical evaluation or performance against a diagnostic gold standard. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, ANSI AAMI) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This device is not described as an AI/ML device that requires a "training set" in the conventional sense of machine learning for diagnostic tasks. Its function is to visualize data from an EAMS.

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

• Not applicable, as there is no mention of a training set for an AI/ML model.

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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

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.

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