The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Device Description

The Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.

AI/ML Overview

The provided text describes a medical device, the "Spinal USA Facet Screw System," and its mechanical testing to demonstrate substantial equivalence to a predicate device. It is a 510(k) premarket notification summary.

Here's a breakdown of the requested information based on the provided text, while noting that many of the requested items are not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Mechanical Performance (ASTM F1264)	Sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing and exceed physiological loads.	"Comparable mechanical performance to the predicate device tested in direct side by side testing." "Demonstrated strengths that exceed all physiological loads and accepted criteria along with spinal column through the facet joint with significant margin of safety provided." "Performed comparably to the commercially available predicate and demonstrated sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing." "Performed well above the acceptance criteria and will adequately stabilize a fusion segment."
Equivalence to Predicate Device	Substantially equivalent in intended use, indications, anatomic sites, performance, and material of manufacture.	"Documentation was provided which demonstrated the Facet Screw System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." "The screws are available in different diameters and lengths to accommodate patient anatomy and are substantially equivalent to the predicate devices."

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

Sample Size: The document does not specify a distinct "test set" sample size for mechanical testing in the way that would apply to clinical performance studies (e.g., number of patients or images). For mechanical testing, the "sample size" would refer to the number of individual screws and/or constructs tested for each mechanical test condition (Axial Pullout, Torque to Failure, Static 3-Point Bending, Dynamic 3-Point Bending). This specific number is not provided in the summary.
Data Provenance: The mechanical testing was "performed per ASTM F1264." This indicates it was laboratory testing conducted according to a recognized standard, not data from human subjects or clinical trials. Therefore, concepts like "country of origin" or "retrospective/prospective" are not applicable here.

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

N/A. This information is not relevant for a mechanical testing study of a medical implant and is not provided in the document. Ground truth as typically defined in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) does not apply to this type of engineering performance evaluation.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or for establishing ground truth for AI model training/testing. This is not applicable to mechanical testing data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not a MRMC comparative effectiveness study. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The submission describes mechanical testing of a surgical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

N/A. This does not involve an algorithm or AI. It is a physical medical device (facet screw system) undergoing mechanical performance testing.

7. Type of Ground Truth Used

The "ground truth" for this engineering study is defined by the measured mechanical properties of the device when subjected to standardized tests (ASTM F1264) and compared against pre-defined acceptance criteria, as well as against the mechanical performance of a predicate device. It's an objective measurement against engineering standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

N/A. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and standards, not data training.

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

N/A. As there is no training set for an AI model, this question is not applicable.

Summary

{0}------------------------------------------------

Date Summary Prepared:	July 5, 2013
Submitter Information:	Spinal USA2050 Executive DrivePearl, MS 39208
Contact Name:Phone:Fax:E-mail:	Charles Vassallo601-420-4244601-420-5501charles.vassallo@precisionspineinc.com
Device Trade Name:	Spinal USA Facet Screw System
Common Name:	Facet Screw System
Regulatory Number:	NA
Classification:	Unclassified
Product Code:	MRW

INTENDED USE:

DEVICE DESCRIPTION:

AUG 0 9 2013

{1}------------------------------------------------

MECHANICAL TESTING:

The Facet Screw System was mechanically tested per ASTM F1264. The objective of the tests where to test the Facet Screw System using the following test methods:

Axial Pullout .
Torque to Failure .
. Static 3 - Point Bending
Dynamic 3 Point Bending .

Conclusions of this testing demonstrated comparable mechanical performance to the predicate device tested in direct side by side testing. It further demonstrated strengths that exceed all physiological loads and accepted criteria along with spinal column through the facet joint with significant margin of safety provided. The Facet Screw System performed comparably to the commercially available predicate and demonstrated sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing. Overall, the Facet Screw System performed well above the acceptance criteria and will adequately stabilize a fusion segment.

EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Facet Screw System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

The overall design of the Facet Screw System consists of screws. The screws are available in different diameters and lengths to accommodate patient anatomy and are substantially equivalent to the predicate devices.

PREDICATE DEVICE:

TranS1 Facet Screw, K073515

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 9, 2013

Mr. Charles Vassallo Senior Director of Quality and Regulatory Spinal United States of America 2050 Executive Drive Pearl, Mississippi 39208

Re: K130863

Trade/Device Name: Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: July 11, 2013 Received: July 11, 2013

Dear Mr. Vassallo:

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. Ilisting 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.

{3}------------------------------------------------

Page 2 - Mr. Charles Vassallo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin | Keith

For

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

Enclosure

{4}------------------------------------------------

Indications for Use

K130863

Device Name: Facet Screw System

Indications for Use:

510(k) Number (if known):

The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ColinFONEill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130863

Regulation Number and Section

N/A