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The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy.

The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, pared with optional targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracked instrument location including deviation from plan.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared track to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To quide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:

• Target position and orientation of the instrument path
• Current position and orientation of the instrument
• Cross sectional images
• 3D model of the patient's spine

Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surgeon to define the target position and orientation as well as the length and diameter of the pedicle screws.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided document does not contain a specific table detailing acceptance criteria and reported device performance with numerical values for metrics like accuracy, precision, or other performance indicators. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only broadly states: "Registration testing was successfully completed using an additional 3D scanner with the OnPoint Augmented Reality Spine System; Testing demonstrated that the device is safe for its intended use and is substantially equivalent to the predicate device." This general statement does not provide quantitative acceptance criteria or performance results.

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

The document does not specify the sample size used for the test set. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, there is no information about the effect size of human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While the study is about an augmented reality system for surgical guidance, which inherently involves human-in-the-loop, the document does not explicitly state if a standalone algorithm-only performance study was conducted for any component of the system. The focus appears to be on the integrated system's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the testing (e.g., expert consensus, pathology, outcomes data). Given the context of a "Stereotaxic Instrument" and "precisely locating anatomic structures," the ground truth likely involved highly accurate measurements obtained through a gold-standard method (e.g., CMM, high-resolution imaging with known fiducials), but this is not specified.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not explain how the ground truth for the training set was established.

Summary of Missing Information:

It's important to note that this FDA clearance letter (510(k) summary) provides a high-level overview for substantial equivalence determination. It often does not include the granular detail about the specific design of validation studies, sample sizes, expert qualifications, or detailed performance metrics that one might find in a full peer-reviewed publication or the complete submission to the FDA. The primary purpose here is to assert that the device is safe and effective compared to a predicate device, without necessarily disclosing all the underlying data.

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