When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components, as well as implant components from other Medtronic Sofamor Danek spinal systems, which can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 4.5mm, 5.5mm, or 6.35mm diameter rods, while other components can connect to both 5.5mm and 6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium implants only. Do not use with stainless steel.

The purpose of this 510(k) submission is to add modified CD HORIZON® ECLIPSE® bone screws to the system.

AI/ML Overview

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. The purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device.

Let's break down the information provided in the context of acceptance criteria and a study proving those criteria.

Key takeaway: This document is a 510(k) submission, not a study report. Therefore, it does not contain information about specific acceptance criteria and detailed device performance metrics derived from a clinical study (like sensitivity, specificity, accuracy, etc.) for a novel AI/software device. Instead, it focuses on demonstrating "substantial equivalence" of a physical implant (spinal system) to a previously cleared version of itself.

Here's how to address your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical medical device (spinal implant) and not a clinical study report for an AI/software device, there isn't a traditional "acceptance criteria" table with performance metrics like sensitivity, specificity, or accuracy that would be applicable to an AI or diagnostic device.

The "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device in terms of:

Intended use
Technological characteristics (materials, design, performance standards)
Safety and effectiveness

The "device performance" in this context refers to the characteristics that allow it to meet the substantial equivalence criteria.

Table: Substantial Equivalence Criteria and Device Characteristics (as per 510(k) process)

Acceptance Criteria Category (for Substantial Equivalence)	Reported Device Characteristics / Performance
Intended Use	CD HORIZON® Spinal System:
(Must be the same as or very similar to predicate)	- Pedicle screw fixation system (non-cervical posterior spine) for: degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion (pseudarthrosis), severe spondylolisthesis (Grades 3 & 4 L5-S1) with autogenous bone graft.
	- Posterior, non-cervical, non-pedicle screw fixation system for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion.
	- Percutaneous posterior approach with SEXTANT instrumentation for: pedicle screw fixation for severe spondylolisthesis (Grades 3 & 4 L5-S1) with autogenous bone graft, and posterior spine thoracic/lumbar system for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion.
	- Anterolateral thoracic/lumbar system (ECLIPSE® components) for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion.
	- Connection to VERTEX™ Reconstruction System (C1-T3) for: DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, tumors.
	Predicate Device: The document states the CD HORIZON® Spinal System is substantially equivalent "to itself" (referencing a previous version of the same product line, K031888 for addition of 6.35 mm rod, implying the prior predicate had similar or identical indications for use).
Technological Characteristics	CD HORIZON® Spinal System:
(Must be same as or similar to predicate device.)	- Components: rods, hooks, screws, CROSSLINK® plates, staples, connecting components.
	- Materials: medical grade stainless steel, medical grade titanium or titanium alloy.
	- Anterior staples: Shape Memory Alloy (Nitinol - NiTi), compatible with titanium implants only.
	- Specific components connect to 4.5mm, 5.5mm, or 6.35mm diameter rods.
	- This submission specifically adds modified CD HORIZON® ECLIPSE® bone screws and 6.35 mm rod to the system.
Safety and Effectiveness	The 510(k) process inherently deems a device safe and effective if it is substantially equivalent to a legally marketed predicate device. The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "proof" in a 510(k). Specific performance data (e.g., biomechanical testing results) would be in an internal design dossier, not typically summarized in this public document unless there were significant changes requiring new performance testing to demonstrate equivalence. The document refers to "summary of safety and effectiveness."

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

Sample Size: Not applicable in the context of this 510(k) submission. This document describes a physical spinal implant system, not a software device requiring a "test set" in the sense of clinical data points for performance evaluation. The "study" mentioned ("Summary of Safety and Effectiveness") refers to the overall documentation supporting the 510(k) submission, not a specific clinical trial with a test set of patient data for performance validation.
Data Provenance: Not applicable for the same reasons. There's no clinical "data" in the sense of patient records or imagery evaluated by an algorithm.

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

Number of Experts/Qualifications: Not applicable. This document is not about establishing ground truth for a test set of data. It's a regulatory submission for a physical device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" of data requiring expert adjudication in this type of submission.

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

MRMC Study / AI Assistance: Not applicable. This document pertains to a physical spinal implant. There is no mention or implication of AI, software, or human reader assistance.

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

Standalone Performance: Not applicable. This is not an AI/algorithm device.

7. The Type of Ground Truth Used

Type of Ground Truth: In the context of a 510(k) for a physical device like this, the "ground truth" for demonstrating substantial equivalence is based on:
- Predicate Device's Established Safety and Effectiveness: The primary "ground truth" is that the previously cleared predicate device (versions of the CD HORIZON® system itself) is already deemed safe and effective for its indicated uses.
- Bench Testing/Engineering Standards (Implied): While not detailed in this summary, the safety and performance of the physical components (e.g., strength, fatigue, biocompatibility) would be evaluated against established engineering standards and specifications.
- Clinical Experience (Implied): The indications for use are based on established clinical practices for spinal surgery.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

Ground Truth for Training Set: Not applicable. No training set is involved.

In Summary:

The provided document is a regulatory approval document (510(k)) for a physical medical device, the CD HORIZON® Spinal System. It demonstrates "substantial equivalence" of newer versions and components to previously cleared versions of the same system. The concepts of "acceptance criteria" and "studies" as typically applied to AI/software performance (e.g., sensitivity, specificity, test/training sets, expert adjudication) are not relevant here. The "study" referenced in the title "Summary of Safety and Effectiveness" refers to the entire body of evidence and documentation presented for the 510(k) submission to the FDA, not a clinical trial evaluating novel performance metrics.

Summary

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JUN 2 7 2003

CD HORIZON® Spinal System Summary of Safety and Effectiveness June 2003

Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pvramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.

Regulation Numbers: 888.3050, 888.3060 and 888.3070

Regulation Names: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle Screw Spinal System.

Codes: KWO, KWP, MNH and MNI

III. Product Description

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The purpose of this 510(k) submission is to add modified CD HORIZON® ECLIPSE® bone screws to the system.

IV. Indications

The CD HORIZON® system is intended for the following indications:

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

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and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

V. Substantial Equivalence

Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an abstract symbol. The symbol consists of three horizontal lines that curve upwards, resembling a stylized representation of a person's profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K031888

Trade Name: CD HORIZON® (Addition of 6.35 mm Rod) Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWQ, KWP Dated: June 17, 2003 Received: June 18, 2003

Dear Dr. Treharne:

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

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Page 2 - Richard W. Treharne, Ph.D.

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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R. Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and , Radiological Health

Enclosure

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Page I of 2 June 2003

510(k) Number (if known): K 03188

Device Name: _________________________________________________________________________________________________________________________________________________________________ CD HORIZON® Spinal System

Indications for Use:

The CD HORIZON® system is intended for the following indications:

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral {L5-S1} vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. .

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), {5} fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

(Continued on the next page)

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(i.e. degencrative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLASTM Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-counter Use

(Optional-296)
Misti N. Mullens

General, Restorative and Neurological Devices

510(k) Number__

0008:

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.