The Raptor™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. Raptor™ Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1 inclusive. The Raptor™ Facet Fixation System is indicated for treatment of any or all of the following:

degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
degenerative disease of the facets with instability
trauma (i.e. fracture or dislocation)
spondylolisthesis
spondylolysis
pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Device Description

The Raptor™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw with Washer and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Raptor™ Facet Fixation System:

The provided documents describe a 510(k) premarket notification for a medical device (Raptor™ Facet Fixation System), which is primarily concerned with demonstrating substantial equivalence to previously cleared devices. This type of submission relies on nonclinical performance data, specifically mechanical testing, rather than studies involving human subjects or AI algorithms. As such, many of the typical questions regarding acceptance criteria for AI/diagnostic devices, such as sample size for test sets, expert adjudication, or MRMC studies, are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are based on established consensus standards for spinal implants, and the performance is demonstrated by meeting the requirements of these standards. Exact numerical pass/fail thresholds are not explicitly detailed in the summary but are implied by adherence to the standards.

Acceptance Criteria (based on consensus standards)	Reported Device Performance
Material Composition: Biocompatible and strong enough for intended use.	Identical to numerous other Alphatec Spine products cleared via 510(k), manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).
Insertion/Removal Torque: Adequate torque capacity for surgical handling without failure. (Per ASTM F543-07)	Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.)
Torque to Failure (Torsional Yield Strength and Breaking Angle): Sufficient resistance to torsional forces experienced during and after implantation. (Per ASTM F543-07)	Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.)
Axial Pullout Strength: Sufficient resistance to dislodgement under axial forces. (Per ASTM F543-07)	Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.)
Static Bending: Ability to withstand static loads without permanent deformation or failure. (Per ASTM-F2193-02(2007))	Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.)
Dynamic Bending: Ability to withstand cyclic loads over time without fatigue failure. (Per ASTM-F2193-02(2007))	Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.)
Overall Performance: Satisfies requirements for posterior supplemental fixation.	The testing demonstrated that the performance characteristics satisfy the requirements of posterior supplemental fixation.
Substantial Equivalence: Similar in general design, intended use, and technological characteristics to predicate devices.	Determined to be substantially equivalent to predicate devices based on non-clinical performance data and engineering analysis.

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

Sample Size for Test Set: Not applicable in the context of this device and submission type. The "test set" here refers to mechanical test specimens (e.g., screws, washers), not patient data or images. The number of specimens tested for each mechanical test (e.g., insertion/removal torque, axial pullout, static/dynamic bending) would be detailed in the full test reports referenced by the ASTM standards, but not in this summary.
Data Provenance: Not applicable. The data is from laboratory mechanical testing of physical device components, not from human subjects or clinical data.

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

Not applicable. Ground truth in this context is defined by objective physical measurements taken during mechanical testing according to standardized protocols (ASTM standards), not by human expert interpretation of clinical data. The "experts" would be the engineers and technicians performing the tests, qualified in mechanical engineering and testing procedures.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against predefined acceptance criteria from the standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting clinical data. The Raptor™ Facet Fixation System is a physical implant, and its assessment focuses on mechanical safety and performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm or AI component to this device.

7. The Type of Ground Truth Used

Mechanical Integrity/Performance Standards: The ground truth is established by the specifications and acceptance criteria outlined in the referenced ASTM international consensus standards (ASTM F543-07, ASTM F2193-02(2007)). The device is deemed safe and effective if it meets or exceeds these pre-defined mechanical performance thresholds.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. This is a physical implant, not an AI model requiring training data.

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

Not applicable, as there is no training set.

Summary

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

NOV 2 8 2011

Raptor™ Facet Fixation System

510(k) SUMMARY July 2011

Submitter: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6739 Fax: (760) 431-0289

Official Contact: Olga Lewis, Regulatory Affairs Specialist

Trade/Model Name: Raptor™ Facet Fixation System

Common or Usual Name: Posterior Facet Screw and Washer

Classification Regulation: MRW - system, facet screw spinal device

Device Description:

Indications for Use

The Raptor™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. Raptor™ Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels form L1-S1 inclusive. The Raptor™ Facet Fixation System is indicated for treatment of any or all of the following:

degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
degenerative disease of the facets with instability
trauma (i.e. fracture or dislocation)
spondylolisthesis
spondylolysis
pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

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

Raptor™ Facet Fixation System

Predicate Devices:

Capture™ Facet Fixation System K092464 Interventional Spine, Inc .PERPOS FCD-2 System K090767 Osteomed Spine Inc. PrimaLOK Facet Fixation System K102438 X-Spine Systems Inc. Fixcet Spinal Fixation Screw System K100154 SpineFrontier Chameleon Fixation System K071420

Technological Characteristics Comparison:

The Raptor™ Facet Fixation System is substantially equivalent to the referenced devices in that it is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is similar in terms of general design, intended use, and technological characteristics to the predicate device.

Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.

Nonclinical Performance Data:

Mechanical testing was performed that provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff.

The following testing was performed for the determination of substantial equivalence:

o Insertion/Removal Torque according to ASTM F543-07
o Torque to failure The torsional yield strength and breaking angle according to ASTM F543-07
o Axial Pullout Strength according to ASTM F543-07
o Static Bending according to ASTM-F2193-02(2007)
o Dynamic Bending according to ASTM-F2193-02(2007)

This testing demonstrated that the performance characteristics satisfy the requirements of posterior supplemental fixation. As a result of this testing and an engineering analysis, the Raptor™ Facet Fixation System is substantially equivalent to predicate devices.

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol, with three diagonal lines converging into a serpentine form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The image is in black and white.

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

NOV 28 2011

Alphatec Spine, Inc. % Ms. Olga Lewis Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K110170

Trade/Device Name: Raptor" Facet Fixation System Regulatory Class: Unclassified Product Code: MR W Dated: November 10, 2011 Received: November 14, 2011

Dear Ms. Lewis:

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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Olga Lewis

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.

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

Sincerely yours,
Erinl Keith

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

Enclosure

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

Raptor™ Facet Fixation System

Section 11 Indications for Use Statement

510(k) Number (if known): K110170

Device Name: Raptor™ Facet Fixation System

Indications for Use:

degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
degenerative disease of the facets with instability -
trauma (i.e. fracture or dislocation)
spondylolisthesis -
" spondvlolvsis
pseudoarthrosis and failed previous fusion which are symptomatic or which may 1 cause secondary instability or deformity

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number	K110170
---------------	---------

Regulation Number and Section

N/A