The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the illum, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488, K130932) are temporary, multiple component systems comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

AI/ML Overview

Here's an analysis of the provided text regarding the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, focusing on acceptance criteria and supporting studies.

Based on the provided FDA 510(k) summary, the device is a spinal fixation system, and the submission is for modifications to previously cleared versions. The type of acceptance criteria and studies described are primarily focused on mechanical performance to demonstrate substantial equivalence to predicate devices, rather than clinical performance (e.g., diagnostic accuracy, treatment outcomes).

It's important to note that the provided documents are regulatory submissions for a Class III medical device (pedicle screw spinal system). For such devices, "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to:

Benchtop Mechanical Testing: To ensure the device new modifications meet established standards (e.g., ASTM standards for mechanical strength, fatigue, etc.) or are at least as good as the predicate device.
Biocompatibility Testing: To ensure the materials are safe for implantation.
Sterilization Validation: To ensure the device can be properly sterilized.

The provided text focuses only on the mechanical testing aspects. Clinical studies involving human subjects with endpoints like "accuracy" or "effect size improvement" are not generally required for 510(k) submissions unless demonstrating a new intended use or significant change that impacts clinical performance in a way not covered by substantial equivalence. This submission is for modifications to existing cleared devices, asserting substantial equivalence.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Device Component/Modification	Acceptance Criteria (Standard & Performance Target)	Reported Device Performance
JANUS Midline Fixation Screw (Cannulated and Non-Cannulated)	Adequate Insertion Torque (Implicitly, to ensure proper screw placement and fixation, likely compared to predicate or established clinical ranges/requirements, though specific values are not explicitly stated as 'acceptance criteria' in this summary).	Insertion Torque Mechanical Testing (Non-Cannulated) was performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate).
Phoenix CDX MIS Spinal Fixation System Modular Mono-Axial Body with Extended Tab	Flexion-Bending tests per ASTM F1798-13. The device must meet or exceed the performance of the predicate device (K130932) with respect to static and fatigue properties of interconnection mechanisms and subassemblies.	Flexion-Bending tests per ASTM F1798-13 were performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate).
Firebird NXG Spinal Fixation System (Set Screw, Multi-Axial Screw Top-Loading Body, Low Profile Offset Body, and Set Screw)	Static and Dynamic Compression Bending, and Static Torsion tests per ASTM F1717-14. The device must meet or exceed the performance of the predicate device (K130932) in a vertebrectomy model.	Static and Dynamic Compression Bending and Static Torsion tests per ASTM F1717-14 were performed. Static Torsion tests were also performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate).
Modified Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Bone Screws	No mechanical testing performed. The modification (increasing thread surface area at the distal tip) was not deemed to affect structural integrity, implying an acceptance criterion that the change should not degrade existing performance.	No mechanical testing performed, as the modification entailed increasing thread surface area at the distal tip with no changes to the structural integrity of the main threaded section or neck. (This implies it's "accepted" based on engineering assessment rather than new test data).

Note on "Acceptance Criteria" and "Reported Device Performance": In this 510(k) summary, the specific numerical acceptance criteria (e.g., minimum load to failure, fatigue life cycles) and the exact numerical results obtained from the tests are not provided. The summary states that testing was "conducted" per the standards and that these tests form the "basis of substantial equivalence." This implies that the devices met the performance targets (typically, at least matching or exceeding the predicate device's performance as per the relevant ASTM standards). For a detailed understanding, one would need to review the full testing reports submitted to the FDA.

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

Sample Size: The document does not specify the exact sample sizes (number of screws, bodies, constructs tested) used for the mechanical benchtop tests. Specific sample sizes are typically detailed in the full mechanical test reports.
Data Provenance: The data comes from benchtop mechanical testing performed by the manufacturer, Orthofix Inc. This is prospective data generated specifically for the 510(k) submission. It is not clinical or patient data and therefore has no country of origin in that sense.

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

This question is not applicable to this type of submission. This 510(k) is for a physical medical device (spinal fixation system) and relies on mechanical engineering principles and testing, not on interpretation of data by human experts to establish "ground truth" in the way an AI diagnostic device would. The "ground truth" here is the physical performance data against established engineering standards or predicate device performance.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are for human-interpreted data (e.g., radiology reads, clinical outcomes) to establish a consensus ground truth. For mechanical benchtop testing, the "adjudication" is typically the comparison of test results against predefined (often standard-based) acceptance criteria by qualified engineers and statisticians.

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

This question is not applicable. An MRMC study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. This submission is for a physical implantable device, not an AI diagnostic tool.

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

This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical performance tests is established by:

Mechanical Engineering Standards: Specifically, ASTM F1798-13 (Flexion-Bending) and ASTM F1717-14 (Static and Dynamic Compression Bending, and Static Torsion). These standards define the test methodologies and often provide guidelines for performance expectations.
Predicate Device Performance: To establish substantial equivalence, the performance of the modified components is compared to the performance of the legally marketed predicate device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, K130932) on which the modifications are based. The implicit ground truth is that the new device's performance must be at least equivalent or better than the predicate.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

This question is not applicable as there is no training set for an AI/ML model.

In summary, the provided document describes a 510(k) submission for modifications to a spinal fixation system. The "acceptance criteria" and "studies" are primarily focused on benchtop mechanical performance testing to ensure the modified components continue to meet established engineering standards and are substantially equivalent to their predicate devices, thereby assuring their safety and effectiveness. The nature of the device means that many of the questions related to AI/ML or clinical ground truth are not relevant.

Summary

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

January 29, 2016

Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K153428

Trade/Device Name: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP Dated: November 24, 2015 Received: November 25, 2015

Dear Ms. Geren:

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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K153428

Device Name

Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System

Indications for Use (Describe)

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the illum, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System

510(k) Owner Information
Name:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214.937.2100214-937-3322jackigeren@orthofix.com
Registration Number:	3008524126
Contact Person:	Jacki Geren, Requlatory Affairs Specialist, II
Date Prepared:	November 24, 2015
Name of DeviceTrade Name / ProprietaryName:	Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
Common Name:	Spinal Fixation System
Product Code:	NKB; OSH; KWP; MNH; MNI
Requlatory Classification:	Class III Pre amendment Device, 21 CFR §888.3070 - Pediclescrew spinal system
Review Panel:	Orthopedic Device Panel
Primary Predicate:	Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System(K130932)
Additional Predicates:	Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System(K151488)Spinal Fixation System (K023498)

Reason for 510(k) Submission:

Orthofix is submitting this Traditional 510(k) premarket notification for the below to the previously cleared Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488):

JANUS Midline Fixation Screw (Cannulated and Non-Cannulated) ●
Phoenix CDX MIS Spinal Fixation System - Modular Mono-Axial Body with Extended Tab
Firebird NXG Spinal Fixation System -●

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Set Screw o
o Multi-Axial Screw Top-Loading Body
Low Profile Off-Set Body O
Modified Firebird Spinal Fixation System Bone Screws ●

Device Description

Intended Use / Indications for Use

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

b) spondvlolisthesis.
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor.
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the subject devices presented in Table 1: Technological Characteristics are similar to the predicate devices in terms of design, dimensions, intended

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use, materials, and performance characteristics. There are no significant differences between the subject devices and the predicate device Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K130932) which would adversely affect the use of the product.

	Subject Device:Firebird Spinal FixationSystem/Phoenix MIS SpinalFixation SystemJANUS Midline Fixation ScrewPhoenix CDX MIS SpinalFixation SystemFirebird NXG Spinal FixationSystem	Primary Predicate Device: FirebirdSpinal Fixation System/PhoenixMIS Spinal Fixation System(K130932)
Device Name	Firebird Spinal FixationSystem/Phoenix MIS SpinalFixation SystemJANUS Midline Fixation BoneScrewPhoenix CDX MIS SpinalFixation SystemFirebird NXG Spinal FixationSystem	Firebird Spinal FixationSystem/Phoenix MIS Spinal FixationSystem (K130932)
Method ofFixation	Non-Cervical Fixation	Non-Cervical Fixation
Implantation	Posterior Approach	Posterior Approach
Design	This system allows a surgeon tobuild a spinal implant construct	This system allows a surgeon to builda spinal implant construct
Material	Titanium alloy (Ti-6AL-4V ELI)	Titanium Alloy (Ti-6AL-4V ELI)

Table 1: Technological Characteristics

PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Mechanical testing was conducted on the subject devices as listed below in Table 2: Mechanical Performance Testing

Table 2: Mechanical Performance Testing
-----------------------------------------	--

Subject Device	Mechanical Testing
JANUS Midline FixationScrew (Cannulated andNon-Cannulated)	Insertion Torque Mechanical Testing (Non-Cannulated)
Phoenix CDX MIS SpinalFixation System ModularMono-Axial Body withExtended Tab	Flexion-Bending tests per ASTM F1798-13 "Standard TestMethod for Evaluating the Static and Fatigue Properties ofInterconnection Mechanisms and Subassemblies Used inSpinal Arthrodesis Implants".
Firebird NXG Spinal	Static and Dynamic Compression Bending and Static Torsiontests per ASTM F1717-14 "Standard Test Mehods forSpinal Implant Constructs in a Vertebrectomy Model."

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Fixation System:• Set Screw• Multi-Axial Screw Top-Loading Body• Low Profile Offset Bodyand Set Screw	Static Torsion tests per ASTM F1717-14 "StandardTest Methods for Spinal Implant Constructs in aVertebrectomy Model."
Modified Firebird SpinalFixation System/PhoenixMIS Spinal Fixation SystemBone Screws	No mechanical testing performed. Modification entailedincreasing thread surface area at the distal tip of thebone screw with no changes to the structural integrityof the main threaded section or neck of the bonescrew.

Basis of Substantial Equivalence

The subject devices will utilize the same intended use, indications for use, and will have the same technological characteristics, design, materials and principles of operation as to the predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K130932).

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.