The G Surgical Marksman System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Device Description

The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

AI/ML Overview

The provided text is a 510(k) summary for the G Surgical Marksman System, which is a thoracolumbosacral pedicle screw system. This type of device is an implant used to stabilize the spine and is regulated as a Class II medical device.

Crucially, a 510(k) submission for this class of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of technological characteristics, rather than clinical efficacy studies on patient outcomes.

Therefore, most of the requested information regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, expert consensus, and stand-alone performance for an AI/algorithm-based device is not applicable to this specific submission because it's for a mechanical implant, not an AI-driven diagnostic or therapeutic system.

Here's a breakdown of the information that is available and why other parts are not:

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

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Static compression bending per ASTM F1717	Marksman System performance demonstrated substantial equivalence to predicate devices.
Dynamic compression bending per ASTM F1717	Marksman System performance demonstrated substantial equivalence to predicate devices.
Static torsion per ASTM F1717	Marksman System performance demonstrated substantial equivalence to predicate devices.

Explanation: The acceptance criteria for this type of device are primarily based on established mechanical testing standards (ASTM F1717) to ensure the implant's structural integrity and durability. The device is considered to meet the acceptance criteria if its mechanical performance is comparable to or better than predicate devices. The document explicitly states that the "mechanical test results demonstrate that G Surgical Marksman System performance is substantially equivalent to the predicate devices."

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

Not Applicable. The "test set" for this device refers to the physical specimens of the implant components that underwent mechanical testing, not a dataset of patient information. The document does not specify the number of samples tested for each mechanical test. Data provenance (country, retrospective/prospective) is not relevant for mechanical device testing.

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 Applicable. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-based devices. For a mechanical implant, the "ground truth" for performance is determined by adherence to engineering specifications and performance in standardized mechanical tests, not expert medical opinion on a dataset.

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

Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for clinical data and diagnostic accuracy. This is not relevant to the mechanical testing of an implant.

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, not done. MRMC studies and the effect size of AI assistance are relevant for AI-powered diagnostic or interpretive tools, where human readers (e.g., radiologists) are involved. This device is a surgical implant and does not involve "human readers" in the context of interpretation.

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

No, not applicable. The G Surgical Marksman System is a physical medical device (pedicle screw system), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

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

Mechanical Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet specified mechanical properties (e.g., strength, durability) as defined by ASTM F1717 and by demonstrating equivalence to the performance of legally marketed predicate devices. There is no biological or diagnostic "ground truth" involved in this type of submission.

8. The sample size for the training set

Not Applicable. There is no "training set" for this device. This term refers to data used to train machine learning algorithms.

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

Not Applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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December 17, 2019

Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

G Surgical LLC % Karen E. Warden, PhD President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026

Re: K193219

Trade/Device Name: G Surgical Marksman System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: November 20, 2019 Received: November 21, 2019

Dear Dr. Warden:

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 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

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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 medical devices and radiation-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,

Colin O'Neill, MBE Assistant Director (Acting) DHT6B: Division of Spinal 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)

K193219

Device Name G Surgical Marksman 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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Section 7 – 510(k) Summary

Date:	20 November 2019
Sponsor:	G Surgical LLC9433 Bee Cave RoadBuilding 3, Suite 101-AAustin, Texas 78733 USATel.: 512.494.4749
Sponsor Contact:	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 Marksman System
Common Name:	Posterior pedicle screw system
Device Classification:	Class II
Regulation Name,Regulation Number,Product Code:	Thoracolumbosacral pedicle screw system, 888.3070, NKB
Submission Purpose:	The subject 510(k) adds modified pedicle screws, rods, crosslinks andfasteners to the cleared components of the Marksman System.
Device Description:	The G Surgical Marksman MIS System consists of longitudinal members(rods), anchors (screws), connectors (crosslinks) and fasteners in a varietyof sizes to accommodate differing anatomic requirements.
Indications for Use:	The G Surgical Marksman System is intended to provide immobilization andstabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletallymature patients as an adjunct to fusion in the treatment of the followingacute and chronic instabilities or deformities: degenerative disc disease(defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma(i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis,kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previousfusion.
Materials:	G Surgical Marksman System is manufactured from Ti-6AI-4V ELI titaniumalloy (ASTM F136) and Cobalt Chrome (per ASTM F1537).
Primary Predicate:	G Surgical Marksman MIS System (G Surgical LLC - K161516)
Additional Predicates:	G Surgical Pedicle System (G Surgical LLC - K081041), Tiger® SpineSystem (CoreLink LLC - K133369), Moss Miami™ Spinal System (DePuyAcroMed, Inc. - K022623) and Optima™ Spinal System (U&I Corporation -K051971)
Performance Data:	Mechanical testing of worst case G Surgical Marksman System constructsincluded static and dynamic compression bending and static torsionaccording to ASTM F1717.The mechanical test results demonstrate that G Surgical Marksman Systemperformance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The G Surgical Marksman System possesses the same technological characteristics as one or more of the predicate devices. These include:intended use (as described above) basic design (rod and screw configuration), material (titanium alloy) and sizes (dimensions are comparable to those offered by the predicate systems) The fundamental scientific technology of the G Surgical Marksman System is the same as previously cleared devices.
Conclusion:	The G Surgical Marksman System possesses the same intended use and technological characteristics as the predicate devices. Therefore G Surgical Marksman System is substantially equivalent for its intended use.

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.