The ICON™ Modular Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft bone. The device is indicated for all of the following indications:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies,
Spondylolisthesis,
Trauma (i.e., fracture or dislocation),
Spinal stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
Tumor,
Pseudoarthrosis, and
Failed previous fusion
The ICON™ Modular Spinal Fixation System components may be used with certain components of the Orthofix SFS system, including rods, rod connectors and cross-connectors.

Device Description

The ICON™ Modular Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The ICON Modular Spinal Fixation System consists of multi-axial pedicle screws, mono-axial pedicle screws. reduction screws, set screws, multi-axial bodies, offset bodies, cross connectors and rods. The ICON Modular Spinal Fixation System may be used with rods, crossconnectors, hooks, spacers, staples, washers, and axial connectors from the Orthofix Spinal Fixation System. The ICON Modular Spinal Fixation System's titanium implants are not compatible with components or metal from any other manufacturer's system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the ICON™ Modular Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical safety or effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets for algorithms, ground truth establishment by experts, and MRMC studies, is generally not applicable to this type of regulatory submission for a spinal fixation system.

Instead, the acceptance criteria and study proving the device meets them revolve around mechanical performance and equivalence to predicate devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards)	Reported Device Performance (Summary)
Static Compression Bending	"Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..."
Dynamic Compression Bending	"Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..."
Static Torsion	"Mechanical testing... was conducted in accordance to ASTM F1717-04 standard... Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..."
Static Grip Strength	"Mechanical testing... was conducted in accordance to... ASTM F1798-97 standard for grip strength. Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices..."
Substantial Equivalence	"Based on mechanical performance evaluations, and equivalence in configuration, indications for use, and fundamental scientific technology, the modified ICON™ Modular Spinal Fixation System is substantially equivalent to the predicate devices. In addition, an extensive clinical comparison of experience with the ICON system compared to literature, MDR reports and FMEA evaluations indications that the ICON system is as safe and as effective as predicate devices, and is expected to perform at least as safely and effectively as the cited predicate devices."

Note: The specific numerical results (e.g., maximum load, cycles to failure) for each test are not provided in this summary but would have been part of the full 510(k) submission. The "reported device performance" here is a high-level summary of the conclusion drawn from those tests – that the device is substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify the sample size for the mechanical tests. Typically, mechanical testing involves a set number of samples per configuration (e.g., screw type, rod length) to meet the requirements of the ASTM standards.
Data Provenance: The data is generated from in vitro mechanical testing performed by the manufacturer, Orthofix Inc., located in Lewisville, Texas, USA. It is not clinical data, so terms like "country of origin of the data," "retrospective," or "prospective" are not applicable in a clinical sense.

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

Not Applicable. This submission relies on in vitro mechanical testing against established industry standards (ASTM F1717-04, ASTM F1798-97) and comparison to predicate devices, not on expert adjudication of clinical outcomes or images. Therefore, clinical "ground truth" established by experts in the context of device performance is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As explained above, this is a mechanical testing and substantial equivalence submission, not a clinical study involving expert adjudication.

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 is a hardware medical device (spinal fixation system), not a diagnostic or AI-driven imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

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

Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is adherence to the performance requirements of the referenced ASTM standards (ASTM F1717-04 and ASTM F1798-97), as well as demonstrating substantial equivalence in mechanical performance and technological characteristics to the identified predicate devices. This is determined by engineering and material science principles, not clinical ground truth.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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FEB 1 6 2012

Premarket Notification 510(k) Orthofix Inc. ICON Modular Spinal Fixation System

510(k) SUMMARY

ICON™ Modular Spinal Fixation System

Submitter InformationName:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, TX 75056
Telephone Number:	214.937.2000
Fax Number:	214.937.2145
Email:	nataliavolosen@orthofix.com
Registration Number:	3008524126
Contact Person:	Natalia VolosenSenior Regulatory Affairs Specialist
Date Prepared:	January 27, 2012
Name of DeviceTrade Name / ProprietaryName:	ICON™ Modular Spinal Fixation System
Common Name:	Spinal Fixation System
Product Code:	MNI, MNH, KWQ, NKB - Spinal Interlaminal FixationOrthosis
Regulatory Classification:	Class II - 888.3060 - Spinal Interlaminal Fixation Orthosis888.3070 Pedicle Screw Spinal SystemClass III - NKB code
Review Panel:	Orthopedic Device Panel (87)
Predicate Devices:	K042514 - Blackstone Modular Pedicle Screw System,SE 10-7-04K022623 - DePuy Moss Miami Spinal System, SE 8-27-02K031585 - U&I Optima Spinal System, SE 6-27-03K023498 - Blackstone STS System, SE 11-13-02K081684 - Blackstone Firebird System, SE 9-15-08

Reason for 510(k) Submission: Modifications to the ICON System

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

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Device Description

Intended Use / Indications for Use

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
ﻨ Spondylolisthesis,
1. Trauma (i.e., fracture or dislocation),
1. Spinal stenosis
1. Deformities or curvatures (i.e., scoliosis, and/or lordosis),
1. Tumor.
1. Pseudoarthrosis, and
1. Failed previous fusion

The ICON™ Modular Spinal Fixation System components may be used with certain components of the Orthofix SFS system, including rods, rod connectors and crossconnectors.

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

Characteristic	Subject Device	Predicates
Device Name	ICON™ ModularSpinal FixationSystem	Blackstone MedicalModular PedicleScrew System(K042514)	Firebird PedicleScrew System(K081684)
Materials	Ti6Al4V Alloy	Ti6Al4V Alloy	Ti6Al4V Alloy
Screw Diameters (mm)	4.5, 5.5, 6.5, 7.5, 8.5	4.5, 5.5, 6.5, 7.5, 8.5	4.5, 5.5, 6.5, 7.5, 8.5
Screw Lengths	25-80mm	25-80mm	25-110mm
Rod Diameters	5.5mm	5.5mm	5.5mm
Rod Diameters	Straight and curved(radii range from 4.42"to 6.85")	Straight and curved(radii range from 4.42"to 6.85")	Straight and curved(radii range from 4.42"to 6.85")

Orthofix inc., 3451 Plano Parkway, Lewisville, Texas 75056 | 214-937-2061 www.orthofix.com

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Characteristic	Standard / Test/ FDAGuidance
Static Compression Bending Test	ASTM F1717-04
Dynamic Compression Bending Test	ASTM F1717-04
Static Torsion	ASTM F1717-04
Static Grip Strength	ASTM F1798-97

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

Performance Data Summary

Mechanical testing of the Orthofix ICON™ Modular Spinal Fixation System was conducted in accordance to ASTM F1717-04 standard for Static & Dynamic Compression Bending test and Static Torsion and ASTM F1798-97 standard for grip strenath. Test results demonstrated that the new, proposed changes are substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

Basis of Substantial Equivalence

Based on mechanical performance evaluations, and equivalence in configuration, indications for use, and fundamental scientific technology, the modified ICON™ Modular Spinal Fixation System is substantially equivalent to the predicate devices. In addition, an extensive clinical comparison of experience with the ICON system compared to literature, MDR reports and FMEA evaluations indications that the ICON system is as safe and as effective as predicate devices, and is expected to perform at least as safely and effectively as the cited predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Orthofix, Incorporated % Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

FEB 1 6 2012

Re: K111448

Trade/Device Name: ICON™ Modular Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, MNH, MNI Dated: January 30, 2012 Received: January 31, 2012

Dear Ms. Volosen:

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 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 (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 - Ms. Natalia Volosen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou dosire specific acri/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mep. 7. www.radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 030 2641 01 (MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For Dan
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 Statement

510(k) Number (if known): K111448 Device Name: ICON™ Modular Spinal Fixation System Indications for Use:

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

The ICON™ Modular Spinal Fixation System components may be used with certain components of the Orthofix SFS system, including rods, rod connectors and cross-connectors.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ > (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CPRH, Office of Device Evaluation (ODE)
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ion Sign-O

Division Sign-Diyision of Surgical, Orthopedic, and Restorative Devices

KIII 144 Q

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.