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The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control of the Catheterization Lab.

The Odyssey Workstation is an optional (large screen) display and user interface package which allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.

Here's an analysis of the provided text regarding the Stereotaxis Odyssey™ Workstation, focusing on acceptance criteria and study information:

Stereotaxis Odyssey™ Workstation Acceptance Criteria and Study Information

The 510(k) summary for the Stereotaxis Odyssey™ Workstation does not explicitly define acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" are implied through the comparison of the device's characteristics to a legally marketed predicate device (the Odyssey™ Workstation in Catheter Lab w/Niobe MNS). The study described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a performance study aiming to meet specific numerical thresholds.

The primary "study" is a comparison of the proposed device's characteristics against a predicate device to affirm substantial equivalence regarding safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a display and user interface package, not a diagnostic algorithm), the acceptance criteria are based on functional and technical characteristics, demonstrating equivalence to the predicate device. The "reported device performance" is the proposed device's characteristics.

Note: The "Acceptance Criteria" column represents the characteristics of the predicate device that the proposed device aims to be substantially equivalent to or improve upon without raising new questions of safety or effectiveness. The "Reported Device Performance" column shows the characteristics of the proposed Odyssey Workstation. The differences (e.g., expanded display options, removal of "keypad controls only Navigant") are presented as improvements or modifications that do not alter the fundamental safety and effectiveness.

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

The document does not describe a traditional "test set" with a defined sample size of patient data. The evaluation is based on comparing the technical specifications and functional capabilities of the new Odyssey Workstation to those of the predicate device. Therefore, there is no patient or image data used for a test set. This is a technical comparison, not a performance study on clinical data.

Data Provenance: Not applicable, as there is no clinical data test set.

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

Not applicable. This submission concerns a display and user interface system, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the confirmed functionality and technical specifications of the device itself and its predicate.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert adjudication described.

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

No, an MRMC comparative effectiveness study was not done. The device is a display and user interface package, not a device that assists human readers in interpreting clinical cases.

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

Not applicable. The Odyssey Workstation is a display and control system for existing diagnostic tools, not an algorithm that performs a standalone diagnostic function. Its purpose is to consolidate existing information for a clinician, implying a human-in-the-loop scenario.

7. The Type of Ground Truth Used

The "ground truth" in this context is the verified technical specifications and functional capabilities of the device, confirmed through engineering design, testing, and comparison to the predicate device's established characteristics. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning algorithm and therefore does not have a "training set" in the conventional sense. Its functionality is based on software and hardware design, not data-driven learning.

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

Not applicable, as there is no training set.

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The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.

The Odyssey Workstation is an optional (large screen) display and user interface package designed to augment the Navigation software system. The Odyssey Workstation allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Odyssey Workstation:

Summary of Acceptance Criteria and Device Performance for the Odyssey Workstation (K072371)

Detailed Study Information:

1. Sample size used for the test set and the data provenance:
   The provided document does not contain details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on comparing the technological characteristics of the proposed device to a predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention any experts or the establishment of ground truth in the context of a performance study with a test set. The submission appears to be based on a comparison of technical specifications rather than a clinical performance study involving expert assessment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Since no specific test set or performance study is described, there is no information about an adjudication method.

4. 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 as the device is not an AI-assisted diagnostic tool. The Odyssey Workstation is a display and user interface package.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   No standalone algorithm performance study was done. The device is a workstation designed to consolidate display and control in a catheter lab, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As there is no mention of a performance study requiring ground truth, this information is not applicable or provided. The basis for clearance appears to be substantial equivalence based on technological characteristics.

7. The sample size for the training set:
   The document does not mention a training set. This device is hardware with an interface, not an AI/ML algorithm that would typically require a training set.

8. How the ground truth for the training set was established:
   Since no training set is discussed, this information is not applicable or provided.

Conclusion on Study Evidence:

The provided 510(k) summary for the Odyssey Workstation (K072371) does not describe a traditional clinical performance study with defined acceptance criteria for accuracy, sensitivity, or specificity, nor does it detail a test set, ground truth, or expert involvement. Instead, the submission demonstrates substantial equivalence by comparing the technological characteristics of the proposed Odyssey Workstation against a legally marketed predicate device (Niobe MNS w/Navigant NWS). The conclusion states: "Based upon the documentation presented in this 510(k) it has been Performance data demonstrated that the Odyssey Workstation is safe and effective when used with the Niobe MNS w/Navigant NWS." This indicates that the clearance was based on demonstrating that the new device's features and performance are substantially similar to or improve upon the predicate device without raising new questions of safety or effectiveness. The "performance data" likely refers to the comparison of the technical specifications listed in the table, showing how the Odyssey Workstation meets or exceeds the capabilities of the predicate in key areas relevant to its intended use as a display and user interface.

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