When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "CD HORIZON™ Fenestrated Screw Set." It describes the device's indications for use, its comparison to predicate devices, and provides a summary of the reasons for its substantial equivalence determination.

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way one would describe a performance study for an AI/algorithm-driven device. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for medical devices in the United States.

Therefore, many of the requested points regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text because the 510(k) submission for this mechanical medical device (spinal screws) does not typically involve such studies as would be performed for a diagnostic or AI-powered device.

Here's a breakdown of what can be inferred from the document regarding "acceptance criteria" in the context of this device, even though it's not a direct answer to the prompt's implied AI/algorithm context:

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

The "acceptance criteria" for this mechanical device are typically based on demonstrating equivalent mechanical and material properties to a legally marketed predicate device. The document does not provide a table with specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) because it's not an AI or diagnostic device.

Instead, the "performance data" mentioned is:

"Non-Clinical mechanical testing of the subject fenestrated screws demonstrating substantial equivalence to the traditional pedicle screws found in the predicate CD HORIZON® Spinal System was previously provided in K152604."

This implies the "acceptance criteria" were related to achieving mechanical performance (e.g., strength, fatigue life, torsional stability) that was demonstrably comparable to the predicate devices. The reported device performance is that these tests showed "substantial equivalence."

2. Sample used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

These questions are not applicable to the type of device and regulatory submission presented. This is a spinal implant, not an AI or diagnostic tool. The "testing" involved non-clinical mechanical testing, not a clinical study with human readers or ground truth established by experts in a diagnostic sense.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as there is no "training set" or "ground truth" in the context of an AI/algorithm for this mechanical device.

Summary based on the document's content:

Device Type: CD HORIZON™ Fenestrated Screw Set, a mechanical spinal implant.
Regulatory Pathway: 510(k) Premarket Notification based on "substantial equivalence."
Nature of "Acceptance Criteria" / Performance Demonstrations: Focused on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices in terms of mechanical properties and material characteristics.
Study Proving Device Meets Criteria: While the document states "Non-Clinical mechanical testing... was previously provided in K152604," it does not detail the specifics of that testing or its sample size within this document. The "proof" is the demonstration of substantial equivalence through this mechanical testing.
Applicability of AI/Algorithm-Specific Questions: Not applicable to this type of medical device submission.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Medtronic Sofamor Danek USA Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pvramid Place Memphis. Tennessee 38132

Re: K170347

Trade/Device Name: CD HORIZON™ Fenestrated Screw Set Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 31, 2017 Received: February 3, 2017

Dear Mr. Grant:

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 of medical device

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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.

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/ResourcesforYou/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,

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) K170347

Device Name

CD HORIZON Fenestrated Screw Set

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 Medtronic Sofamor Danek USA CD HORIZON™ Fenestrated Screw Set

	March 2017
Submitter	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact(s)	Lee GrantDistinguished Regulatory Affairs AdvisorDirect Telephone - 901-344-0807
Date Prepared	March 30, 2017
Common Name	CD HORIZON™ Fenestrated Screw SetCD HORIZON™ Fenestrated Screw Set
Regulatory Class	Class II, NKB
Regulation Number	21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System
Regulation Name and DeviceProduct Classification Code
Predicate Devices	K113174 - CD HORIZON™ Spinal System (SE 11/21/11)Secondary PredicateK152604 – CD HORIZON™ Fenestrated Screw Set (SE 01/06/16)The predicate devices have not been subject to a design related recall
Description of Device	The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulatedmulti-axial screws (MAS) with fenestrations offered in diameters ranging from4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CDHORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implantscontained in the CD HORIZON™ Spinal System. The CD HORIZON™Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and6.0mm diameter rods and associated connecting components contained withinthe CD HORIZON™ Spinal System. The screws contain six fenestrations nearthe distal tip of the screw which provides a controlled means to deliver a smallamount of polymethylmethacrylate (PMMA) bone cement into a targetedvertebral body. These implants may also serve as traditional pedicle screws whenused without bone cement. These screws are provided non-sterile.
Submission Purpose	The subject CD HORIZON™ Fenestrated Screws are being introduced into themarket for use without cement, for standard CD HORIZON® Spinal Systemindications.
Indications for Use:	When used without cement, the CD HORIZON Fenestrated Screws (with orwithout SEXTANT® or LONGITUDE® instrumentation) are intended forposterior, non-cervical fixation as an adjunct to fusion for the followingindications: degenerative disc disease (defined as back pain of discogenic originwith degeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failedprevious fusion.When used in conjunction with KYPHON HV-R™ Fenestrated Screw BoneCement, the CD HORIZON™ Fenestrated Screws are intended to restore theintegrity of the spinal column even in the absence of fusion for a limited time
period in patients with advanced stage tumors involving the thoracic and lumbar
spine in whom life expectancy is of insufficient duration to permit achievement
of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-
RTM Fenestrated Screw Cement are for use at spinal levels where the structural
integrity of the spine is not severely compromised.
Comparison of TechnologicalCharacteristics with thePredicate Devices	The screws which comprise the CD HORIZON™ Fenestrated Screw Set areidentical to those cleared in the previous CD HORIZON™ Fenestrated ScrewSet in K152604 for the same indications when used in conjunction with cementaugmentation. These screws were declared substantially equivalent to non-augmented CD HORIZON Spinal System screws cleared in K113164 for whichthe same non-cement augmented indications stated in the Indications for Usesection. No modifications have been made to the subject screws. They areidentical to the predicate screws with respect to indications, design, size,intended use, cannulation, fundamental scientific technology, and materials.
Performance Data	Non-Clinical mechanical testing of the subject fenestrated screws demonstratingsubstantial equivalence to the traditional pedicle screws found in the predicateCD HORIZON® Spinal System was previously provided in K152604.
Conclusion	Based on the information provided herein, the subject CD HORIZON®Fenestrated Screws are substantially equivalent to the predicate CD HORIZON®Spinal System screws cleared in K113174

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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.