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510(k) Data Aggregation
(47 days)
The O-arm™ Imaging System is designed for 2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
The O-arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors). The 1-D Display Control Mouse is an optional accessory. It is a sterile disposable limited-function wireless mouse. With the 1-D Mouse, a surgeon can remotely control and point at the O-arm™ image display. The 1-D mouse is similar to remote controls for controlling projectors during business presentations. The 1-D Mouse allows the surgeon to control what is displayed and to point out features on the image with a laser pointer.
This document is a 510(k) summary for the O-arm™ Imaging System with a 1-D Display Control Mouse. It's a submission to the FDA for market clearance, not a study report demonstrating the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for a robust clinical study is not available in the provided text.
The core of this submission is to establish substantial equivalence to a previously cleared device (O-arm™ Imaging System, K050996), primarily by demonstrating that the addition of a sterile, wireless 1-D display control mouse does not alter the safety or effectiveness of the system.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the document because it is a 510(k) summary for an accessory, not a performance study. The "performance" discussed primarily relates to the functionality of the new mouse and its impact on the overall system's predicate comparison.
| Acceptance Criteria (Inferred from Substantial Equivalence Logic) | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness Equivalence: The O-arm™ Imaging System with the 1-D Mouse must be as safe and effective as the predicate O-arm™ Imaging System (cleared in K050996). | "The O-arm™ Imaging System with 1-D Mouse is virtually identical in safety and effectiveness to the previously cleared O-arm™ Imaging System." |
| Functional Equivalence of Mouse: The 1-D Mouse must perform the display control functions similar to the standard mouse. | "The display control functions provided by the optional sterile disposable wireless 1-D Control Mouse are also provided by console controls and by a non-sterile, hard-wired mouse on the standard O-arm™ Imaging System." |
| "With the 1-D Mouse, a surgeon can remotely control and point at the O-arm™ image display." | |
| "The 1-D Mouse allows the surgeon to control what is displayed and to point out features on the image with a laser pointer." | |
| No Adverse Co-existence/Interference: The wireless nature of the 1-D Mouse should not introduce issues with co-existence, data latency, integrity, or security. | "The low power, unique communication protocol, and limited function of the 1-D Mouse ensure no co-existence, data latency and integrity, or security issues that might affect safety or effectiveness." |
| Maintenance of Sterile Field: The sterile and wireless nature should facilitate maintaining the sterile field. | "The sterile and wireless characteristics allow use by the surgeon without compromising the sterile field and without cluttering the surgical area with a mouse cable." |
| "The 1-D mouse provides simpler controls, reduced cable clutter, and greater assurance of maintaining the sterile field." | |
| No Transmission of Clinical Information: The mouse should only transmit control commands. | "No clinical information is transmitted by mouse, only display control commands." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available. The document focuses on demonstrating substantial equivalence based on the nature of the device (an accessory for display control) and its limited function. It does not describe a test set or clinical study in the traditional sense with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. No human-reader study or expert evaluation for ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available. No adjudication method is described as there's no clinical test set described.
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, a MRMC comparative effectiveness study was not done. This document is for a medical imaging system accessory (a mouse), not an AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is an imaging system accessory and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available. No ground truth for image interpretation or diagnosis is relevant to the functionality of a display control mouse.
8. The sample size for the training set:
This information is not available. This is not an AI or machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
This information is not available. See point 8.
In summary, the provided document is a 510(k) premarket notification for an accessory (a control mouse) to an existing imaging system. The primary goal is to demonstrate "substantial equivalence" to the predicate device, arguing that the new accessory does not change the fundamental safety or effectiveness of the imaging system itself. Therefore, detailed clinical study data, acceptance criteria related to diagnostic performance, or ground truth establishment (as would be required for a novel diagnostic device or AI algorithm) are not pertinent to this submission and are not included.
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