SPARTAN S3 FACET SYSTEM by AMENDIA, INC.

The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

Trauma, including spinal fractures and/or dislocations;
Spondylolisthesis;
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Device Description

The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

AI/ML Overview

The provided text describes a 510(k) summary for the Spartan S2 Facet System, a medical device. This document focuses on establishing substantial equivalence for market clearance, rather than presenting a study demonstrating the device meets a predetermined set of acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set size, ground truth establishment for training) cannot be answered from the provided text.

The document states: "The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." This implies that the 'acceptance criteria' for this clearance process was the demonstration of substantial equivalence through pre-clinical testing, likely mechanical or material testing as is common for implants. However, the specific details of these tests and their results are not provided.

Here is what can be inferred or explicitly stated from the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Pre-clinical testing indicates substantial equivalence to predicate devices (DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657), and Trans 1 Facet Screw (K073515)).
Adequacy for Intended Use	Pre-clinical testing indicates adequacy for the intended use.

2. Sample size used for the test set and the data provenance:

Not Applicable / Not Provided. The document refers to "pre-clinical testing," which typically involves mechanical and material testing, not human subject data or a "test set" in the context of AI performance evaluation. The type of data provenance would likely be laboratory test results, not country of origin for patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Provided. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-driven devices. This document refers to a physical implant.

4. Adjudication method for the test set:

Not Applicable / Not Provided. Adjudication methods are typically used in clinical studies involving observer interpretation, not for mechanical device testing.

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. This is a 510(k) summary for a physical implant, not an AI-assisted diagnostic device. Therefore, an MRMC study related to AI assistance would not be performed.

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

No. This is a physical implant, not an algorithm.

7. The type of ground truth used:

Not Applicable / Not Provided for typical AI/diagnostic ground truth. For a physical implant, "ground truth" would relate to material properties and mechanical performance meeting engineering specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense for diagnostic accuracy.

8. The sample size for the training set:

Not Applicable / Not Provided. Training sets are relevant for machine learning algorithms.

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

Not Applicable / Not Provided.

Summary

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4. 510(k) Summary according to 807.92(c)

Contact:	Tim LusbyAmendia TM, INC1155 Allgood Road, Suite 6Marietta, GA 30062770-874-0935
Trade Name:	Spartan S3 Facet System	NOV 1 7 2009
Product Class:	Unclassified
Classification:	Unclassified
Product Codes:	MRW
Panel Code:	87

Indications for Use: The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

Trauma, including spinal fractures and/or dislocations;

1. Spondylolisthesis:

Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Device Description: The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

Predicate Device(s): The predicate devices previously cleared by FDA are the DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657) and the Trans 1 Facet Screw (K073515).

Performance Testing: The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.

Page 1 of 1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Amendia, Inc. % Silver Pine Consulting Mr. Richard Jansen President 13540 Guild Avenue Apple Valley, Minnesota 55124

NOV 17 2009

Re: K092568

Trade/Device Name: Spartan S- Facet System Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: August 19, 2009 Received: August 20, 2009

Dear Mr. Jansen:

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. 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.

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

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Page 2 - Mr. Richard Jansen

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jmeta J

Image /page/2/Picture/6 description: The image contains a handwritten letter 'g' in a cursive style. The letter is written in black ink and appears to be isolated on a white background. The stroke of the letter starts with a loop at the top and extends downwards with a curved tail.

Mark N. Mělkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Statement of Indications for Use

510(k) Number (if known): Kn92569

The Spartan S Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

Trauma, including spinal fractures and/or dislocations;
Spondylolisthesis;
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Division Sign-Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K092568 Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A