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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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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 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, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual 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 tracking information of the tracked instrument location 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 tracking technology is used 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 guide 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 toolpath
• . Current position and orientation of 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 surqeon to define the target position and orientation as well as length and diameter of the pedicle screws.

The OnPoint Augmented Reality Spine System consists of the following components:

• Tracking camera, workstation, and cart ●
• . Headsets with supplemental battery
• . Software
• Tracked instruments and adapters ●

The provided text, a 510(k) summary for the OnPoint Augmented Reality Spine System, describes various performance tests conducted to demonstrate the device's substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or detailed results for all mentioned tests in a comparative format.

The document primarily focuses on explaining the types of tests performed rather than presenting the quantitative acceptance criteria and the actual performance data against those criteria. It states that "Verification/validation testing... has been successfully completed and demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device," but does not explicitly list the numerical results that support this claim for each criterion.

Based on the provided text, I can infer and extract some information related to your request, but many details, particularly the quantitative performance data against specific acceptance criteria, are not present.

Here's a breakdown of what can be extracted and what is missing, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, only one specific numerical acceptance criterion is explicitly stated for the "System Accuracy Requirement":

Note: The document states that the system's accuracy was validated in a cadaver study, and that "positional and trajectory errors were calculated," but it does not then report the calculated values against these 2.0mm and 2° criteria. It only states that the device "functions as intended" and "demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device."

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

• Cadaver Study (Accuracy Validation): The document mentions "a cadaver study" (singular) for accuracy validation. It does not specify the number of cadavers used, the number of screw placements, or the number of anatomical regions targeted.
• Registration Testing: "multiple 3D CT scanners" were used, but the number of scanners or the number of tests performed is not specified.
• OnPoint AR Image Quality Testing: No sample size is mentioned.
• Human Factors Usability Testing: No specific sample size (number of users or use cases) is mentioned, other than "intended users."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it is a 510(k) submission to the FDA, the studies would typically be conducted to support a premarket notification for a U.S. device. Cadaver studies are inherently prospective for the data collection.

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

• The document states that "Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans." This implies expert review. However, it does not specify the number of experts involved in this evaluation or their qualifications (e.g., "Radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

• The document mentions "viewing the post-op scans" for clinical accuracy (Gertzbein-Robbins score). This suggests a review process, but it does not specify any adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert reviews, if multiple experts were used.

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 document does not describe an MRMC comparative effectiveness study in the context of human readers improving with AI assistance. The device is a "Spine Navigation System" with "Augmented Reality," intended to aid in precisely locating anatomical structures during surgery. It is not an AI diagnostic algorithm for image reading. The clinical accuracy assessment focusing on the Gertzbein-Robbins score post-op is an objective measure of screw placement, not a comparative reading study.

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

• The "System Level Accuracy" (mean 3D positional error and mean trajectory error) and "tracking accuracy verified per ASTM F2554-22" tests are fundamentally standalone (algorithm only) performance evaluations of the navigation system's precision, without direct human-in-the-loop variable performance being assessed in these specific metrics. The human factors testing assesses usability with humans, but the precision measurements themselves are of the system.

7. The Type of Ground Truth Used

• For System Accuracy (Positional and Trajectory Error): The ground truth was established by comparing the "actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory." This implies a measurement against a known physical ground truth (actual screw placement) compared to the system's virtual representation.
• For Clinical Accuracy (Gertzbein-Robbins score): The ground truth was established by "viewing the post-op scans." This implies expert consensus/interpretation of post-operative imaging, typically CT scans, to evaluate the accuracy of screw placement in relation to the vertebral canal. This is a common clinical scoring system.

8. The Sample Size for the Training Set

• The document describes performance testing for a medical device, not explicitly an AI model that requires a "training set" in the machine learning sense. The software mentioned (OnPoint Augmented Reality Spine System Software) is part of a navigation system, not a deep learning model that would typically undergo a separate training and validation split. Therefore, a "training set" as understood in AI/ML is not applicable or mentioned in this context. The testing described focuses on system accuracy, software verification, and human factors, which are standard for surgical navigation devices.

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

• As a "training set" for an AI/ML model is not applicable to the device description in the document, this question is not relevant based on the provided information.

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