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).

Device Description

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.

AI/ML Overview

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

Criterion Description	Acceptance Metric/Standard	Reported Device Performance
Safety and Efficacy for Accuracy	Demonstrated substantial equivalence (SE) to predicate devices regarding safety and efficacy for accuracy in navigating anatomical structures during spinal surgery.	"The E-GPS Navigated Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance. The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate."
Compatibility with Robotic Platform	Compatibility and intended use with the Globus Medical Excelsius GPS® Robotic Navigation Platform, which itself is intended for "precisely locating anatomical structures and for the special positioning and orientation of an instrument holder or guide tube."	"specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform" and intended to "assist the surgeon in precisely locating anatomical structures." Its function is tied to the cleared predicate robotic system.
Compatibility with Screw Systems	Limited to use only with specified Reform® Spinal Fixation Systems (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).	Explicitly stated: "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)."
Material and Manufacturing	Manufactured from stainless steel per ASTM F899; reusable.	"The instruments are manufactured from stainless steel per ASTM F899." and "are non-sterile, reusable instruments."
Technological Characteristics	Similar device design and dimensions, indications for use, materials of manufacture, and principles of operation to predicate devices, with minor differences not raising new safety/effectiveness issues. (This defines "substantial equivalence" for a mechanical device).	"The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of the safety and effectiveness. Specifically, the following characteristic are the similar between the subject and predicates: - Device design and dimensions, - Indications for use, - Materials of manufacture, - Principles of operation."

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.

Summary

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July 14, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precision Spine, Inc. % Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K220862

Trade/Device Name: E-GPS Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 15, 2022 Received: June 16, 2022

Dear Nathan Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220862

Device Name E-GPS Navigated Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) � Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The Counter Use (21 CFR 801 Subpart C)

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K220862 - 510(K) SUMMARY

Submitter's Name:	Precision Spine, Inc.
Submitter's Address:	2050 Executive DrivePearl, Mississippi 39208
Submitter's Telephone:	1-601-420-4244
Contact Person:	Nathan Wright MSEmpirical Testing Corp.1-719-351-0248nwright@empiricaltech.comImage: Empirical Testing Corp. Logo
Date Summary was Prepared:	March 22, 2022
Trade or Proprietary Name:	E-GPS Navigated Instruments
Common or Usual Name:	Orthopedic Stereotaxic Instruments
Classification:	Class II per 21 CFR §882.4560
Product Code:	OLO
Classification Panel:	Orthopedic - Stereotaxic, Trauma and Restorative Devices (DHT6C)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of the safety and effectiveness. Specifically, the following characteristic are the similar between the subject and predicates:

Device design and dimensions ●
Indications for use ●
Materials of manufacture ●
. Principles of operation

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Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	ProductCode	PredicateType
K171651	EXCELSIUS GPS™	Globus Medical Inc.	OLO	Primary
K200303	Reform Pedicle Screw System	Precision Spine	NKB, KWP	Additional
K173130	Reform® Midline Cortical Screw System	Precision Spine, Inc.	NKB	Additional

PERFORMANCE DATA

The E-GPS Navigated Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance.

The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate.

CONCLUSION

The overall technology characteristics and engineering analysis lead to the conclusion that the E-GPS Navigated Instruments are substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).