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The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1).

The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

Device Description

The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan.

AI/ML Overview

The provided text describes the "Practical Navigation Surgical Guidance System" and its substantial equivalence to a predicate device, focusing on its technical characteristics and indications for use. However, the document does not contain a detailed study report that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

While the document mentions performance data, it lists only the types of tests conducted (non-clinical verification/validation, cadaver/simulated-use, and adherence to specific ASTM and IEC standards) rather than reporting the actual quantitative results or outlining acceptance criteria for those results.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, and MRMC studies cannot be extracted directly from this document.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated in Document: The document outlines the types of tests performed (e.g., non-clinical verification, cadaver studies), but does not specify quantifiable acceptance criteria (e.g., "accuracy must be within X mm" or "sensitivity must be > Y%").	Not Explicitly Stated in Document: The document mentions that the system "was tested in accordance with the design requirements" and lists the types of tests conducted (e.g., ASTM F2554-10 for Positional Accuracy). However, it does not provide the numerical results or metrics from these tests. It concludes generally that "the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness," implying the tests met their underlying objectives.

Acceptance Criteria

Reported Device Performance

Not Explicitly Stated in Document: The document outlines the types of tests performed (e.g., non-clinical verification, cadaver studies), but does not specify quantifiable acceptance criteria (e.g., "accuracy must be within X mm" or "sensitivity must be > Y%").

Not Explicitly Stated in Document: The document mentions that the system "was tested in accordance with the design requirements" and lists the types of tests conducted (e.g., ASTM F2554-10 for Positional Accuracy). However, it does not provide the numerical results or metrics from these tests. It concludes generally that "the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness," implying the tests met their underlying objectives.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "cadaver and simulated-use testing," but no number of cadavers or simulated scenarios is provided.
Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not detail how ground truth was established for any performance testing, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified. The document does not describe any adjudication method used for the test set.

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 MRMC study was done, nor is it applicable in this context. The device is a surgical guidance system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest related "assistance" would be its guidance for surgeons, but the document does not present any comparative effectiveness study with and without the device.

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

A standalone performance evaluation of the system's accuracy was implicitly done. The document states: "ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard inherently evaluates the accuracy of the system itself (algorithm and hardware) in positioning, which can be considered a form of standalone performance. However, the results of this test are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for the cadaver/simulated-use testing. For "Positional Accuracy," the ground truth typically involves highly accurate measurements from a reference system or physical targets, which serves as the "true" position against which the device's measurements are compared.

8. The sample size for the training set

Not applicable / Not specified. This device is a surgical navigation system, not a machine learning model that would typically require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its software is likely developed using engineering principles and verification/validation against specifications, rather than trained on a large dataset of patient images in an AI/ML context.

9. How the ground truth for the training set was established

Not applicable / Not specified. As noted above, typical machine learning training sets are not relevant here.

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