The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The icotec Pedicle System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for fixation of the non-cervical spine. The icotec Pedicle System is comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. The icotec Pedicle System can be used for single or multiple level fixations.

AI/ML Overview

This document is a 510(k) premarket notification for the icotec Pedicle System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided text in the context of the requested information about acceptance criteria and evidence of meeting them:

Critically, this document is a 510(k) submission for a pedicle screw spinal system, a physical medical device (implant). It is not a document describing an AI/ML medical device submission. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, AUC) are not directly applicable in the way your prompt expects for an AI/ML device.

This 510(k) demonstrates substantial equivalence primarily through:

Intended Use, Material, Geometry, Method of Fixation, and Mechanical Properties comparison with predicate devices.
Mechanical Testing (non-clinical) to show that the device performs equivalently to previously cleared devices under simulated physiological conditions.

Given this, I will interpret your questions in the context of a physical medical device's submission dossier.

1. A table of acceptance criteria and the reported device performance

For a physical device like a pedicle screw system, acceptance criteria are generally related to mechanical performance, material properties, and design specifications. The document states that the device meets these through comparison to predicates and non-clinical testing.

Acceptance Criteria Category (Implied)	Reported Device Performance
Mechanical Properties	Demonstrated substantial equivalence to previously cleared devices per ASTM F1717 (static compression bending, static torsion, and dynamic compression bending testing). This implies that the device performs within the expected range for pedicle screw systems, comparable to the predicate devices under these test conditions.
Material	Manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), which is a common and accepted material for such implants. Stated as substantially equivalent to predicate devices in material.
Geometry	Comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. Stated as substantially equivalent to predicate devices in geometry.
Method of Fixation	Posterior pedicle screw system. Stated as substantially equivalent to predicate devices in method of fixation.
Intended Use	Matches the indications for use of the predicate devices.

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

For physical device mechanical testing (preclinical testing), "sample size" refers to the number of devices or test specimens used in the mechanical tests (e.g., number of screws tested for bending strength). This information is not provided in this summary. Such details would typically be in the full test reports submitted to the FDA, not in the 510(k) summary.

Data provenance: The mechanical tests were performed by "the company" (icotec AG). The tests are "non-clinical," implying laboratory-based testing rather than patient data.

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

This concept is not directly applicable to a physical device's mechanical or material testing. There isn't "ground truth" derived from expert consensus for device mechanical properties in the way there is for image interpretation in an AI/ML study. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717) and the physical measurements themselves.

4. Adjudication method for the test set

Not applicable for mechanical testing of a physical device.

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 510(k) for a physical implant, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a 510(k) for a physical implant, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering standards (ASTM F1717) and the measured mechanical properties of the device components, demonstrating equivalence to the predicate devices. There is no biological/clinical "ground truth" from patients or pathology in this specific context of demonstrating substantial equivalence via preclinical testing.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a traditional 510(k) for a physical medical device. The device design and manufacturing process are established, and then the product is tested against established standards and predicates.

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

Not applicable. See point 8.

Summary

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

April 12, 2016

Icotec AG % Mr. Samuel Pollard Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K151977

Trade/Device Name: icotec Pedicle System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 14, 2016 Received: March 15, 2016

Dear Mr. Pollard:

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) K151977

Device Name icotec Pedicle System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	icotec Pedicle System
Manufacturer:	Icotec AGIndustriestrasse 129450 AltstättenSwitzerland
Contact:	Mr. Jörg SchneiderManager Regulatory Affairsicotec agIndustriestrasse 129450 Altstaetten, SwitzerlandPhone: +41 71 757.0025Fax: +41 71 757.0001joerg.schneider@icotec.ch
Prepared by:	Samuel PollardMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: 202.552.5800spollard@mcra.com
Date Prepared:	December 17, 2015
Classification:	21 CFR §888.3070: Pedicle screw spinal system
Class:	III
Product Code:	NKB, MNI, MNH
Primary Predicate:	CoreLink Tiger Spine System (K113058)
Additional Predicate:	Amedica Valeo PS System (K072022)

Indications for Use:

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Device Description:

Predicate Devices:

The icotec Pedicle System is substantially equivalent to the primary predicate CoreLink Tiger Spine System (K113058) and reference predicate Amedica Valeo PS System (K072022) with respect to intended use, material, geometry, method of fixation, and mechanical properties. Mechanical testing, including static and dynamic compression bending and static torsion testing, has demonstrated substantial equivalence to previously cleared devices.

Preclinical Testing:

The non-clinical tests performed by the company include static compression bending, static torsion, and dynamic compression bending testing per ASTM F1717 of the worst case pedicle screw system. The results of the performed tests demonstrate that the icotec Pedicle System is substantially equivalent to legally marketed predicate devices.

Conclusion:

The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the icotec Pedicle System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.

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.