When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

Device Description

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System." This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance data for a standalone device in a clinical setting.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, and human-in-the-loop performance, are not applicable or not available in this type of submission.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where the requested details are not relevant to this submission:

1. Table of acceptance criteria and reported device performance:

This device is a spinal implant for fixation. The "acceptance criteria" here relate to meeting the performance characteristics of predicate devices through mechanical testing and demonstrating substantial equivalence in design, materials, and intended use. The performance is reported in terms of passing these mechanical tests.

Acceptance Criteria (Based on ASTM F1717)	Reported Device Performance
Static Axial Compression Bending test	Passed
Static Torsion test	Passed
Dynamic Axial Compression Bending test	Passed
Dynamic Torsion test	Passed

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

Sample Size: Not applicable in the context of clinical data for diagnostic or AI performance. The "test set" here refers to the physical samples of the device components subjected to mechanical testing. The document does not specify the number of individual components tested but implies sufficient testing to meet ASTM F1717 standards.
Data Provenance: Not applicable in the context of clinical data. The mechanical testing was performed in a lab setting.

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

Not applicable. This submission does not involve clinical data requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is adherence to established mechanical testing standards (ASTM F1717).

4. Adjudication method for the test set:

Not applicable. This submission does not involve clinical data requiring adjudication. Mechanical test results are objective measurements against defined standards.

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 not an AI or diagnostic device. It's a spinal implant. MRMC studies are not relevant to this type of device submission.

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

No. This is not an AI or algorithm-based device. "Standalone" performance as a diagnostic algorithm is not applicable. The device's "standalone" performance is its mechanical integrity under various loads, which was tested.

7. The type of ground truth used:

Mechanical Testing Standards (ASTM F1717): The "ground truth" for this device's performance relies on its ability to withstand specified mechanical forces and stresses according to a recognized standard (ASTM F1717). This standard dictates the test methods and performance metrics for spinal implant constructs.
Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications, anatomic sites, performance, and material of manufacture.

8. The sample size for the training set:

Not applicable. This submission does not involve an AI model or a "training set" in the context of machine learning.

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

Not applicable. As there is no AI model or training set, this question is not relevant.

Summary of the K112025 Submission:

This 510(k) submission for the Sure Lok Mini Posterior Cervical/Upper Thoracic System focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

Matching Intended Use and Indications: The device shares the same intended use and indications for fusion of the cervical spine as its predicates.
Similar Design and Materials: The components (polyaxial screws, rods, hooks) are described as similar in design concept, screw thread type, size, length, locking mechanisms, torque, angulation, and dimensions to predicate systems. All components are fabricated from titanium alloy, the same material as the predicates.
Mechanical Testing: Performance was verified through mechanical testing performed according to ASTM F1717, a recognized standard for spinal implant constructs. This testing confirmed the device's mechanical integrity under static and dynamic axial compression bending and torsion, demonstrating comparable performance to predicate devices.

The information provided does not pertain to the evaluation of a diagnostic device or an AI algorithm, but rather a physical implant device where regulatory clearance relies on established engineering principles and comparison to existing, cleared products.

Summary

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K112025 page 1/2

SEP 1 5 2011

Image /page/0/Picture/2 description: The image shows the logo for Spinal USA. The words "Spinal USA" are written in white letters on a black rectangle. A drawing of a spine is between the words "Spinal" and "USA".

2050 Executive Drive Pearl, MS 39208

Ph: 601-420-4244 Fax: 601-420-5501

510(k) Summary

Date Summary Prepared:	July 11, 2011
Submitter Information:	Spinal USA2050 Executive DrivePearl, MS 39208
Contact Name:Phone:Fax:E-mail:	Frankie Cummins601-420-4244601-420-5501fc@spinalusa.com
Device Trade Name:	Sure Lok Mini Posterior Cervical/Upper Thoracic System
Common Name:	Spinal Interlaminal Fixation Orthosis
Regulatory Number:	888.3050
Classification:	Class II
Product Code:	K WP
Predicate Device:	Synthes - Cervifix System (K991089)Alphatec - Solanas System (K052201)Seaspine - Sierra System (K072729)

INTENDED USE:

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis

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K112025 page 2/2

-Spinal Stenosis -Fracture/dislocation

-Revision of previous cervical spine surgery
-Tumors

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

DEVICE DESCRIPTION:

EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Sure Lok Mini Posterior Cervical/Upper Thoracic System is substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

Components of the Sure Lok Mini Posterior Cervical/Upper Thoracic System are similar to the predicate systems. The design concept of the polyaxial pedicle screw of the Solanas and Sierra systems are similar to the Sure Lok Mini Posterior Cervical/Upper Thoracic system. The screw thread type, size and length are similar as is the polyaxial ball joint locking mechanism and rod clamping cap screw. The same applies to the rescue screw design. The cap screw torque applied to seat the cap screw is similar to the predicates. Screw angulation is also similar. Rod design is similar to the predicate systems. Rod diameter is either the same or larger. Rod lengths are similar to the predicates. Hook type, shape, size are similar to the predicates. Cross links, domino, and offsets are similar to the predicates. Material is the same as the predicates. Sterilization is the same as the predicates.

The following mechanical testing was performed on the Sure Lok Mini Posterior Cervical/Upper Thoracic System. Testing was performed according to ASTM F1717: Static Axial Compression Bending test, Static Torsion test, Dynamic Axial Compression Bending test, and Dynamic Torsion test.

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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 stylized graphic of an eagle or bird-like figure with three wing-like shapes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 1 (090)3 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spinal USA % Mr. Frankie Cummins 2050 Executive Drive Pearl, Mississippi 39208

SEP 15 2001

Re: K112025

Trade/Device Name: Sure Lok Mini Posterior Cervical/ Upper Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class H Product Code: KWP Dated: July 13, 2011 Received: July 15, 2011

Dear Mr. Cummins:

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. 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

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Page 2 - Mr. Frankie Cummins

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 (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/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 vours,

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Indications for Use

Device Name: Sure Lok Mini Posterior Cervical/Upper Thoracic System

Indications for Use:

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis -Spinal Stenosis -Fracture/dislocation -Revision of previous cervical spine surgery -Tumors

The use of polyaxial screws is limited to placement in the upper.thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

Prescription Use _ X (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)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.