MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM by STRYKER SPINE

The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
트 Spondylolisthesis;
l Trauma (i.e., fracture or dislocation);
I Spinal stenosis;
트 Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
. Tumor:
트 Pseudoarthrosis; and
l Failed previous fusion.

The Stryker Spine TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axis Cross Connector.

Device Description

This 510(k) is intended to introduce a line extension to the existing TRIO+ Spinal System. The line extension consists of additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for a line extension to the TRIO+ Spinal Fixation System. This is a medical device submission, and the focus of such a submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through engineering analysis and comparison of device characteristics and intended use.

Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "experts," "adjudication," "multi-reader multi-case study," and "standalone performance" do not directly apply in the context of this specific regulatory document.

Medical devices like the TRIO+ Spinal Fixation System are typically evaluated for mechanical performance, biocompatibility, and substantial equivalence to predicate devices. The "study" in this context refers to engineering analyses and testing to ensure the new components meet established standards and perform comparably to existing, approved components.

Here's a breakdown of why these AI/Machine Learning related questions are not applicable to the provided document and what information is present:

Not Applicable AI/Machine Learning Concepts:

Acceptance Criteria & Reported Device Performance (Table): There are no specific AI model performance metrics (e.g., accuracy, sensitivity, specificity) or "acceptance criteria" for such metrics listed. The "performance" is about mechanical strength, material properties, and functionality of a spinal implant.
Sample Sized used for the test set and the data provenance: There is no "test set" in the sense of a dataset for an AI model. The "testing" involves mechanical and possibly biological evaluations, not data analysis for AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" in this context would refer to the true state of the spine for diagnostic purposes, which is not what this device is. This device is a treatment system.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for evaluating diagnostic performance of imaging interpretations, often comparing human readers with and without AI assistance. This device is a surgical implant, not a diagnostic tool or AI software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): "Ground truth" does not apply in the context of an orthopedic implant.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What is present in the document related to the device's evaluation:

Device Name: TRIO+ Spinal Fixation System - Line Extension
Description of Modification: Additional lengths for 4.5 mm and 5.5 mm diameter standard post screws.
Intended Use / Indications for Use: Posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for various spinal conditions (Degenerative disc disease, Spondylolisthesis, Trauma, Spinal stenosis, Curvatures, Tumor, Pseudoarthrosis, Failed previous fusion).
Predicate Devices: Stryker Spine TRIO Spinal Fixation System (K052971), Stryker Spine TRIO and TRIO+ Spinal Systems (K062698, K070368), Medtronic Sofamor Danek TSRH Spinal System (K020699, K021170).
Demonstration of Equivalence: The document states, "Engineering analysis was completed for the subject screw components and demonstrates equivalence to the predicate product as well as compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004." This is crucial for a 510(k) submission, as it forms the basis for regulatory clearance. It confirms that the device meets the safety and effectiveness profile of already-approved devices through engineering testing and comparison, not through clinical trials or AI performance evaluations as implied by the questions.
Regulatory Clearance: The FDA's letter (K100737 dated April 12, 2010) states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

In summary, the provided text describes a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or treatment software. Therefore, the questions about AI acceptance criteria, ground truth, expert adjudication, and various study types related to AI performance are not relevant to this document. The "study" mentioned is an "engineering analysis" to demonstrate mechanical and functional equivalence to existing devices.

Summary

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TRIO+ Spinal Fixation System -- Line Extension

Special 510(k) Premarket Notification

Special 510(k) Summary of Safety and Effectiveness: TRIO+ Spinal System - Line Extension

Proprietary Name:	TRIO+ Spinal Fixation System	APR 12 2010
Common Name:	Spinal Fixation Appliances
Classification Name and Reference:	1) Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2)2) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060
Device Product Code:	NKB, MNH, MNI
Proposed Regulatory Class:	Class III
For Information contact:	Curtis TruesdaleRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8296Fax: (201) 760-8496Email: Curtis.Truesdale@Stryker.com
Date Summary Prepared:	April 9, 2010
Predicate Devices	Stryker Spine TRIO Spinal Fixation System, K052971;Stryker Spine TRIO and TRIO+ Spinal Systems,K062698, K070368.Medtronic Sofamor Danek TSRH Spinal System,K020699, K021170.

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TRIO+ Spinal Fixation System - Line Extension

Special 510(k) Premarket Notification

Description of Device Modification

Intended Use

The TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
트 Spondylolisthesis;
l Trauma (i.e., fracture or dislocation);
I Spinal stenosis;
트 Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
. Tumor:
트 Pseudoarthrosis; and
l Failed previous fusion.

The Stryker Spine TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axis Cross Connector.

The Stryker Spine TRIO+ Spinal Fixation System, with the Summary of the Technological incorporation of the subject components, is substantially equivalent Characteristics to the predicate devices in terms of material, design, and indications for use. Engineering analysis was completed for the subject screw components and demonstrates equivalence to the predicate product as well as compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.

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

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

APR 1 2 2010

Re: K100737

Trade/Device Name: TRIO® Plus Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 01, 2010 Received: March 15, 2010

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. 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

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Page 2 - Mr. Curtis D. Truesdale

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buching
for

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TRIO+ Spinal Fixation System Line Extension - Additional Screws

Indications for Use:

The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

Degenerative disc disease (defined as back pain of discogenic origin with ■ degeneration of the disc confirmed by history and radiographic studies);
Spondylolisthesis;
Trauma (i.e. fracture or dislocation);
Spinal stenosis;
Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
트 Tumor:
트 Pseudoarthrosis; and
트 Failed previous fusion.

The TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axia Cross Connector.

Prescription Use AND/OR (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)

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

K100737 510(k) Number_

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.