(83 days)
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)
| Acceptance Criteria (Device Characteristic) | Proposed Odyssey Workstation (Reported Performance) | Predicate Niobe MNS w/Navigant NWS (Predicate Performance) |
|---|---|---|
| Display (monitor) Size | 46" | 23" |
| Pixel Resolution | 1920 x 1080 | 1920 x 1200 |
| Allowable Video Sources | 12 | 2 |
| Allows control of connected video sources. | Yes | One video source is controllable, the other is not. |
| Keypad controls only Navigant | Yes | Yes |
| Allows control of video sources' native keypad and mouse. | Yes | Yes |
| Displays graphics & verbiage of connected video sources. | Yes | Yes |
| Allows the user to choose between predetermined layout/scripts or a customizable display. | Yes | Yes |
| Allows user interaction between video sources on the display. | Yes | Yes |
| Save display layout | Yes | Yes |
| Print display layout | No | Yes |
Detailed Study Information:
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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. -
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. -
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. -
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. -
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. -
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. -
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. -
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.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).