When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 1) Degenerative Disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); 2) Pseudoarthrosis 3) Spondylolysis 4) Spondyloisthesis 5) Trauma (i.e. Fracture of Dislocation) 6) Deformities (i.e. Scoliosis or Lordosis) 7) Spinal Stenosis 8) Failed previous Fusion. When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 1) Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2) Trauma (i.e. Fracture or Dislocation) 3) Spinal Stenosis 4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis) 5) Tumors 6) Failed Previous Fusion

Device Description

The Stryker Spine THOR™ Anterior Plating System is designed for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking rings to accommodate the insertion of bone screws.

AI/ML Overview

The Stryker Spine THOR™ Anterior Plating System is a medical device for spinal stabilization. The provided text, a 510(k) Premarket Notification, describes the device and its indications for use, but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data or algorithm-based evaluations.

The relevant section states:

"Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed for the THORTM Anterior Plating System, and demonstrated equivalent mechanical performance characteristics to the Stryker Spine CENTAUR Spinal System [510(k) K994347, K001844] and Stryker Spine Xia Stainless Steel System [510(k) K012870]. The subject THORTM system demonstrated equivalent material biocompatibility and intended use as the Stryker Spine CENTAUR Spinal System and the previously cleared THORTM Anterior Plating System [510(k) K073437]."

This indicates that the device's substantial equivalence was established through mechanical testing and material biocompatibility testing, comparing it to predicate devices. This is a common approach for 510(k) submissions, where a new device demonstrates that it is as safe and effective as a legally marketed device.

Therefore, many of the requested details, particularly those related to clinical studies, AI performance, ground truth, and expert evaluation, are not applicable or not present in this type of regulatory document for this specific device.

However, based on the provided text, I can infer some aspects relevant to the "acceptance criteria" through the lens of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) premarket notification for a spinal implant, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to existing predicate devices. The performance is reported in terms of equivalence rather than absolute metrics.

Acceptance Criteria (Implied for 510(k) Submission)	Reported Device Performance
Mechanical Performance: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System, Stryker Spine Xia Stainless Steel System)	Demonstrated equivalent mechanical performance characteristics to the predicate devices.
Material Biocompatibility: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System)	Demonstrated equivalent material biocompatibility to the predicate devices.
Intended Use: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System, previously cleared THOR™ Anterior Plating System [K073437])	Demonstrated equivalent intended use as the predicate devices.
Indications for Use: Matches or is a subset of predicate devices	The stated Indications for Use align with or are a subset of the Indications for Use of the predicate devices, as approved by FDA's substantial equivalence determination.

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

The document specifies "Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed." This testing would involve mechanical and material integrity tests on device samples, likely under laboratory conditions (e.g., fatigue testing, static strength testing).

Sample size: Not explicitly stated in the document. For mechanical testing, this would typically be a statistically relevant number of physical device samples (e.g., N=5 or N=6 per test condition as per ISO standards commonly referenced in FDA guidance for implants).
Data provenance: Laboratory testing (likely in-house or by a contracted lab for Stryker Spine). Not clinical or patient-derived data in this context.

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

Not applicable. For mechanical and biocompatibility testing, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO standards) and FDA guidance for test protocols, rather than expert consensus on clinical cases. The experts involved would be engineers and material scientists designing and conducting the tests.

4. Adjudication method for the test set

Not applicable. Mechanical and biocompatibility tests have objective pass/fail criteria based on predefined stress, strain, force, or material interaction limits, often compared directly to predicate device performance or established safety thresholds.

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

Not applicable. This device is a passive spinal implant (anterior plating system) and does not involve AI, image analysis by human readers, or diagnostic capabilities that would warrant an MRMC study.

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

Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission relates to:

Compliance with mechanical performance standards and FDA guidance for spinal implants.
Material properties (chemical composition, biocompatibility) meeting established standards for medical-grade Titanium alloy.
Functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of AI or machine learning. Its design, manufacturing, and testing follow engineering principles and regulatory standards.

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

Not applicable (see above).

Summary

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h0773

Stryker Spine THOR™ Anterior Plating System

Traditional 510(k) Premarket Notification

JUN - 9 2008 510(k) Summary: THOR™ Anterior Plating System

Stryker Spine Submitter: 2 Pearl Court Allendale, New Jersey 07401

Mr. Curtis Truesdale Contact Person Regulatory Affairs Project Manager Phone: 201-760-8296 FAX: 201-760-8496 Email: curtis.truesdale(@stryker.com

March 17, 2008 Date Prepared

Stryker Spine THORTM Anterior Plating System Trade Name Class II Proposed Class Spinal Intervertebral Body Fixation Orthosis Classification Name 21 CFR 888.3060 and Number KWQ Product Code

Stryker Spine THOR Anterior Plating System: 510(k) #K073437 Predicate Devices Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870
The Stryker Spine THOR™ Anterior Plating System is designed Device Description for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking rings to accommodate the insertion of bone screws.

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Indications for Use (continued)

When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

1. Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
1. Trauma (i.e. Fracture or Dislocation)
1. Spinal Stenosis
1. Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
1. Tumors
1. Failed Previous Fusion

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Intended Use When used as an anterior non-pedicle fixation system, in the lumbar and lumbosacral spine (L1-S1), THOR™ Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. THOR™ Anterior plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients 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);
. Pseudoarthrosis;
. Spondylolysis;
. Spondylolisthesis;
Trauma (i.e., fracture or dislocation); .
. Deformities (i.e. scoliosis or lordosis);
. Spinal Stenosis; and
. Failed Previous Fusion.

When used as an anterolateral non-pedicle fixation system, in the thoracic and thoracolumbar spine (TI-L5), THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);

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Trauma (i.e. fracture or dislocation); .
Spinal stenosis; .
Deformities (i.e. scoliosis, kyphosis and/or lordosis); .
Tumors; and .
Failed Previous Fusion. .

Summary of theTechnologicalCharacteristics	Testing in compliance with FDA's Guidance for Spinal System510(k)'s May 3, 2004 was performed for the THORTM AnteriorPlating System, and demonstrated equivalent mechanicalperformance characteristics to the Stryker Spine CENTAURSpinal System [510(k) K994347, K001844] and Stryker SpineXia Stainless Steel System [510(k) K012870]. The subjectTHORTM system demonstrated equivalent materialbiocompatibility and intended use as the Stryker SpineCENTAUR Spinal System and the previously cleared THORTMAnterior Plating System [510(k) K073437].
----------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Summary of theTechnologicalCharacteristics

Testing in compliance with FDA's Guidance for Spinal System510(k)'s May 3, 2004 was performed for the THORTM AnteriorPlating System, and demonstrated equivalent mechanicalperformance characteristics to the Stryker Spine CENTAURSpinal System [510(k) K994347, K001844] and Stryker SpineXia Stainless Steel System [510(k) K012870]. The subjectTHORTM system demonstrated equivalent materialbiocompatibility and intended use as the Stryker SpineCENTAUR Spinal System and the previously cleared THORTMAnterior Plating System [510(k) K073437].

----------------------------------------------------

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2008

Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K080773

Trade/Device Name: THOR Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: March 17, 2008 Received: March 19, 2008

Dear Mr. Truesdale:

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 such 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); 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.

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Page 2 - Mr. Curtis Truesdale

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Stryker Spine THORTM Anterior Plating System

Indications for Use

510(k) Number (if known): K 080773

Device Name: Stryker Spine THOR™ Anterior Plating System

Indications for Use:

1. Degenerative Disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
1. Pseudoarthrosis
1. Spondylolysis
Spondyloisthesis 4)
Trauma (i.e. Fracture of Dislocation) 5)
Deformities (i.e. Scoliosis or Lordosis) 6)
Spinal Stenosis 7)
Failed previous Fusion 8)

INDICATIONS CONTINUE ON NEXT PAGE

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle - for mkg

Division of General, Restora and Neurological Devices

Page 1 of 2

510(k) Number K080773

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K050773

Traditional 510(k) Premarket Notification

Indications for Use (continued)

When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skelefally mature patients in the treatment of the following acute and chronic instabilities or deformities:

1. Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
1. Trauma (i.e. Fracture or Dislocation)
1. Spinal Stenosis
1. Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
1. Tumors
1. Failed Previous Fusion

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.