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The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for use as an aid for precisely locating anatomical structures and for the special positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).

Precision Spine E-GPS Navigated Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "E-GPS Navigated Instruments."

Important Note: The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report for an AI/ML medical device. As such, much of the requested information (especially regarding AI-specific criteria, human reader studies, and large-scale data sets typically associated with AI/ML performance validation) is not present in this document.

The document describes a medical device, the "E-GPS Navigated Instruments," which are reusable surgical instruments designed to work with a robotic navigation platform. This is a mechanical device, not an AI/ML algorithm. Therefore, the acceptance criteria and study described are for a traditional medical device, primarily related to its mechanical and functional compatibility.

Acceptance Criteria and Study for "E-GPS Navigated Instruments"

Given that this is a mechanical instrument and not an AI/ML algorithm, the requested information elements related to AI/ML performance, ground truth establishment for large datasets, and reader studies are not applicable or provided. The "study" here refers to a performance evaluation for a mechanical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The evaluation was based on an "engineering analysis and geometric comparison" to predicate devices. This indicates that the "test set" was not a collection of patient data or images, but rather the design specifications, material properties, and physical dimensions of the E-GPS Navigated Instruments and their predicate counterparts.
• Sample Size: Not applicable in the traditional sense of patient data. It's an analysis of the device itself and its interaction with the robotic platform.
• Data Provenance: Not applicable. This is not a study derived from patient data.

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

• Number of Experts: Not applicable. Ground truth, in the context of an engineering analysis of a mechanical device for substantial equivalence, is established through compliance with engineering standards, material specifications, and comparison to validated predicate device designs.
• Qualifications of Experts: N/A for this type of evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation of data for consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is not an AI algorithm that would assist human readers in interpreting medical images. It's a surgical instrument.
• Effect Size: Not applicable.

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

• Standalone Performance: No, this is not an algorithm. The "performance" described is the device's functional integrity and compatibility with a robotic system and screws, proven by engineering analysis.

7. The Type of Ground Truth Used

• Ground Truth Type: For this 510(k), the "ground truth" for demonstrating substantial equivalence is established through:
  • Engineering specifications and standards: Compliance with ASTM F899 for materials.
  • Comparison to legally marketed predicate devices: The functional and design characteristics of the E-GPS Navigated Instruments were compared to the Globus Medical Excelsius GPS™ (K171651) for the main robotic platform compatibility and Precision Spine's Reform Pedicle Screw System (K200303) and Reform® Midline Cortical Screw System (K173130) for screw system compatibility. The "ground truth" is that these predicate devices are already deemed safe and effective by the FDA, and the new device being sufficiently similar implies equivalent safety and effectiveness.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth Establishment for Training Set: Not applicable. There is no training set for this mechanical device.

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