When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with KYPHON® HV-R Fenestrated Screw 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

KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.
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 screws are provided non-sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for the KYPHON HV-R® Fenestrated Screw Cement and CD HORIZON® Fenestrated Screw Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific metrics like sensitivity, specificity, or reader performance.

Therefore, many of the requested details about acceptance criteria, study design for performance measurement, ground truth, and expert involvement are not available in this type of regulatory document.

However, I can extract information regarding performance data and the overall conclusion.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not Applicable. The document explicitly states "Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." This indicates that the performance data was used to demonstrate that the new device is as safe and effective as the predicate devices, rather than meeting predefined acceptance criteria for diagnostic performance metrics (like sensitivity/specificity) for a specific task (e.g., detecting a condition). The performance data cited would likely be mechanical properties, biocompatibility, or other engineering parameters relevant to medical devices, not diagnostic accuracy.

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

Not Available. The document does not specify test set sample sizes or data provenance. The "clinical data" mentioned would typically be focused on patient outcomes and safety profiles compared to predicate devices, not on a "test set" for an AI algorithm's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This device is a medical implant and bone cement system, not an AI diagnostic tool. Therefore, there is no "ground truth for a test set" in the context of expert review for diagnostic accuracy as there would be for an AI algorithm. Ground truth, if applicable in a clinical study for an implant, would relate to patient outcomes, imaging results post-procedure, or pathology reports after explantation, which are typically assessed by treating physicians or pathologists, not necessarily a panel of experts specifically for "ground truth establishment" in the way it's described for AI.

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

Not Applicable. As explained above, this is not an AI diagnostic device and therefore, adjudication methods for a test set based on expert review are not relevant to this document.

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 medical device (cement and screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described in this document.

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

Not Applicable. This is not an algorithm or AI system.

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

Outcomes Data/Substantial Equivalence to Predicates: While not framed as "ground truth" for an AI, the "Performance Data" and "Clinical Data and Non-Clinical testing" would have relied on various forms of data to demonstrate safety and effectiveness. For implants, this typically includes:
- Mechanical Testing Data: Demonstrating the physical properties (strength, fatigue, etc.) of the cement and screws.
- Biocompatibility Testing: Ensuring the materials are safe for implantation.
- Clinical Outcomes Data: Potentially from studies comparing the device to existing treatments, or from safety monitoring, though detailed clinical trial results are not provided in a 510(k) summary. The primary "ground truth" here is often the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. This is a medical device, not an AI model requiring a training set.

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

Not Applicable. This is a medical device, not an AI model.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "AI performance study" framework, it does describe its substantial equivalence to predicate devices based on presented data.

Device(s) being reviewed:

KYPHON HV-R® Fenestrated Screw Cement
CD HORIZON® Fenestrated Screw Set

Predicate Devices:

KYPHON® HV-R® Bone Cement (K150460)
CD HORIZON® Spinal System (K042025 and K113174)

Basis of Substantial Equivalence (implied "performance criteria" for a 510(k) device):
The substantial equivalence is based on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable performance to the legally marketed predicate devices. The document explicitly states:

KYPHON HV-R® Fenestrated Screw Cement: "identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement... The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors..."
CD HORIZON® Fenestrated Screw Set: "have the same or similar indications, intended use, fundamental scientific technology, and are manufactured from similar materials as the pedicle screws found in the following FDA cleared CD HORIZON® Spinal System applications... The primary difference is the subject screws contain fenestrations which allow PMMA cement to flow in a controlled manner through the screw and into the targeted pedicle."

Conclusion:
"Based on the provided performance data, the subject KYPHON® HV-R Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated Screw Set is substantially equivalent to the CD HORIZON® Spinal System (K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011))."

Performance Data Mentioned:
"Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." (Details of this data are not provided in this summary.)

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

January 6, 2016

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

Re: K152604

Trade/Device Name: KYPHON HV-R® Fenestrated Screw Cement, CD HORIZON® Fenestrated Screw Set Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, MNI Dated: December 8, 2015 Received: December 9, 2015

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

{1}------------------------------------------------

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 yours,

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152604

Device Name KYPHON HV-R® Fenestrated Screw Cement

Indications for Use (Describe)

When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Coment is 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

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)
---------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K152604

Device Name CD HORIZON® Fenestrated Screw Set

Indications for Use (Describe)

When used in conjunction with KYPHON HV-R® Fenestrated Screw 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 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{4}------------------------------------------------

510(k) Summary – K152604

Medtronic Sofamor Danek USA, Inc.

December 2015

Submitter	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact(s)	Lee GrantDistinguished Regulatory Affairs AdvisorDirect Telephone – 901-344-0807Pamela EdwardsPrincipal Regulatory Affairs SpecialistDirect Telephone -901-399-2125
Date Prepared	December 30, 2015
Trade Name	1) KYPHON HV-R® Fenestrated Screw Cement2) CD HORIZON® Fenestrated Screw Set
Regulatory Class	1) KYPHON HV-R® Fenestrated Screw CementClass II
Regulation Number	888.3027 Polymethylmethacrylate (PMMA) Bone CementPML
Regulation Name and DeviceProduct Classification Code	2) CD HORIZON® Fenestrated Screw SetClass II21 CFR 888.3070 Pedicle Screw SystemMNI
Predicate Devices	1) KYPHON® HV-R® Bone Cement (Primary Predicate)K150460 KYPHON® HV-R® Bone Cement (SE 04/28/15)2) CD HORIZON® Spinal SystemK042025 CD HORIZON® Spinal System (SE 08/25/04) andK113174 CD HORIZON® Spinal System (SE 11/21/11)
	The predicate devices have not been subject to a design related recall
Description of Device	1) KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMAbased (high viscosity, radiopaque) bone cement. KYPHON HV-R®Fenestrated Screw Cement will be provided sterile in two components:20 grams of powder and nine grams of liquid. The powder containsmethylmethacrylate-styrene co-polymer, barium sulfate as aradiopacifier, and di-benzoyl peroxide as an initiator. This liquidcontains methylmethacrylate monomer, N, N dimethyl-p-toluidine as apromoter and hydroquinone as a stabilizer. The powder and liquid
	components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.
	2) 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 screws are provided non-sterile.
Indications for Use:	1) KYPHON HV-R® Fenestrated Screw Cement: When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
	2) CD HORIZON® Fenestrated Screw Set: When used in conjunction with KYPHON® HV-R Fenestrated Screw 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.
Comparison of TechnologicalCharacteristics with thePredicate Devices	1) The KYPHON® HV-R® Fenestrated Screw Cement is identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement cleared by the FDA in K150460 (SE 04/28/15). The predicate cement is intended to be used in patients diagnosed with pathological fractures in the vertebral body caused by conditions such as osteoporosis and cancer. The subject cement is also intended to be used in patients with metastatic cancer. Pathological fractures reflect one means in which spinal instability occurs and therefore in both instances the predicate and subject cement are intended to treat spinal instability. The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of
	fusion.
	2) The screws which comprise the CD HORIZON® Fenestrated Screw Sethave the same or similar indications, intended use, fundamentalscientific technology, and are manufactured from similar materials as thepedicle screws found in the following FDA cleared CD HORIZON®Spinal System applications: K042025 (SE 08/25/2004) and K113174(SE 11/21/2011). The predicate screws in this application are cleared forpedicle fixation in patients with spinal instability caused by tumors. Thesubject pedicle screws are also intended to provide pedicle fixation inpatients diagnosed with spinal instability caused by tumors. Both thepredicate and subject screws are cannulated, are manufactured from thesame material, are similar in design, sizes and are intended to be usedwith the same spinal rods and connecting components. The primarydifference is the subject screws contain fenestrations which allowPMMA cement to flow in a controlled manner through the screw andinto the targeted pedicle.
Performance Data	Clinical data and Non-Clinical testing were provided in support of substantialequivalence of the subject device.
Conclusion	Based on the provided performance data, the subject KYPHON® HV-RFenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R®Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® FenestratedScrew Set is substantially equivalent to the CD HORIZON® Spinal System(K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011)).

{5}------------------------------------------------

{6}------------------------------------------------

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”