The G Surgical OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The G Surgical OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the G Surgical OCT Spinal System may be connected to the G Surgical Pedicle System (GPS™) using 3.5mm/6.0mm axial connectors, domino connectors and transition rods.

Device Description

G Surgical OCT Spinal System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the G Surgical OCT Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing benchmarks, not on clinical performance or diagnostic accuracy of an AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable or cannot be extracted from this document.

However, I can provide the available information regarding the device's performance data as it relates to mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the G Surgical OCT Spinal System are not explicitly stated in a quantitative table within this document. Instead, the document refers to industry standards for mechanical testing and implies that performance equivalent to predicate devices is the acceptance criterion.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical performance of worst-case constructs according to ASTM F1717 for static and dynamic compression bending and static torsion, and ASTM F2706 for static and dynamic compression bending and torsion.	"The mechanical test results demonstrate that G Surgical OCT Spinal System performance is substantially equivalent to the predicate devices." (Specifically, the Synapse OCT - K142838, Virage OCT Spinal System - K153631, CerviFix StarLock System - K994187, and Uniplate Anterior Cervical Plate - K042544). The document does not provide specific quantitative results from these mechanical tests, only the conclusion of substantial equivalence.

Acceptance Criterion (Implicit)

Reported Device Performance

Mechanical performance of worst-case constructs according to ASTM F1717 for static and dynamic compression bending and static torsion, and ASTM F2706 for static and dynamic compression bending and torsion.

"The mechanical test results demonstrate that G Surgical OCT Spinal System performance is substantially equivalent to the predicate devices." (Specifically, the Synapse OCT - K142838, Virage OCT Spinal System - K153631, CerviFix StarLock System - K994187, and Uniplate Anterior Cervical Plate - K042544). The document does not provide specific quantitative results from these mechanical tests, only the conclusion of substantial equivalence.

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

This document describes a medical device (surgical implant) and its mechanical performance, not an AI device or a diagnostic test. Therefore, the concept of a "test set" in the context of clinical data, along with data provenance (country of origin, retrospective/prospective) is not applicable to the information provided. The "test set" here refers to the physical samples of the device constructs used for mechanical testing. The sample size for these mechanical tests is not specified in this summary.

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

This information is not applicable. Ground truth, in the context of this document, refers to the physical properties and mechanical behavior of the device components as tested against established engineering standards (ASTM F1717, ASTM F2706). The "ground truth" is verified through engineering testing, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Given that this concerns mechanical testing of an orthopedic implant, there is no expert adjudication process for a "test set" of clinical data.

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

This information is not applicable. The device described is a spinal implant for surgical use, not an AI-assisted diagnostic tool or an imaging system requiring human readers.

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

This information is not applicable as the device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this document is primarily based on engineering standards and mechanical test results. The device's performance is compared against the performance of legally marketed predicate devices, as demonstrated through adherence to ASTM F1717 and ASTM F2706 standards for spinal implant testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI device for this document. The mechanical testing does not involve machine learning or AI.

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

This information is not applicable. As explained above, there is no training set for an AI device in this context.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2017

G Surgical LLC % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. P.O. Box 566 Chesterland, Ohio 44026-2141

Re: K171834

Trade/Device Name: G Surgical OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: November 24, 2017 Received: November 28, 2017

Dear Dr. Warden:

We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171834

Device Name G Surgical OCT Spinal System

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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510(k) Summary

Date:	16 June 2017
Sponsor:	G Surgical LLC9433 Bee Cave RoadBuilding 3, Suite 101-AAustin, Texas 78733 USATel.: 512.494.4749
Contact Person:	Don Grafton, Managing Director
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Proposed Trade Name:	G Surgical OCT Spinal System
Common Name:	Posterior occipital-cervical-thoracic system
Device Classification	Class II
Classification Name;Regulation; DeviceProduct Code:	Orthosis, Cervical Pedicle Screw Spine Fixation; Pre-amendment; NKGAppliance, Fixation, Spinal Interlaminal: 888.3050; KWP
Device Description:	G Surgical OCT Spinal System consists of longitudinal members, anchors,interconnecting devices and fasteners in a variety of sizes to accommodatediffering anatomic requirements. The implants are sold non-sterile.
Intended Use:	The G Surgical OCT Spinal System is intended to provide immobilizationand stabilization of spinal segments as an adjunct to fusion for the followingacute and chronic instabilities of the craniocervical junction, cervical spine(C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fracturesand/or traumatic dislocations; instability or deformity; failed previous fusions(e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; anddegenerative disease, including intractable radiculopathy and/ormyelopathy, neck and/or arm pain of discogenic origin as confirmed byradiographic studies, and degenerative disease of the facets with instability.The G Surgical OCT Spinal System is also intended to restore the integrityof the spinal column even in the absence of fusion for a limited time periodin patients with advanced stage tumors involving the cervical spine in whomlife expectancy is of insufficient duration to permit achievement of fusion.In order to achieve additional levels of fixation, the G Surgical OCT SpinalSystem may be connected to the G Surgical Pedicle System (GPS™) using3.5mm/6.0mm axial connectors, domino connectors and transition rods.
Materials:	The G Surgical OCT Spinal System is manufactured from Ti-6Al-4V ELItitanium alloy (ASTM F136).
Primary Predicate	Synapse OCT (DePuy Synthes Spine - K142838)
Additional Predicates:	Virage OCT Spinal System (Zimmer Spine Inc. - K153631)CerviFix StarLock System (Synthes USA - K994187)Uniplate Anterior Cervical Plate (DePuy Spine - K042544)
Performance Data:	Mechanical testing of worst case G Surgical OCT Spinal System constructsincluded static and dynamic compression bending and static torsionaccording to ASTM F1717 and static and dynamic compression bendingand torsion according to ASTM F2706.The mechanical test results demonstrate that G Surgical OCT SpinalSystem performance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The G Surgical OCT Spinal System possesses similar technologicalcharacteristics as the predicate devices. These include:performance (as described above), basic design (rod, plate and screw configuration), material (titanium alloy), and sizes (dimensions are comparable to those offered by the predicatesystems). Therefore the fundamental scientific technology of the G Surgical OCTSpinal System is the same as previously cleared devices.
Conclusion:	The G Surgical OCT Spinal System possess the same intended use andtechnological characteristics as the predicate devices. Therefore the GSurgical OCT Spinal System is substantially equivalent for its intended use.

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Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.