Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Device Description

Kyphon® Xpede™ Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Kyphon® Xpede™ Bone Cement), and as such, it does not contain the type of detailed study information typically found in a clinical trial report or a performance study for AI/AI-assisted devices.

The document states that the subject device is "substantially equivalent" to a legally marketed predicate device (Kyphon® Xpede™ Bone Cement K102397 S.E. 2/28/2011). This means the manufacturer is asserting that the new device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, and has not raised new issues of safety or effectiveness with its revised indications for use.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance, training set details) are not applicable (N/A) because the FDA's clearance is based on substantial equivalence to an existing device, rather than a de novo clinical performance study against specific acceptance criteria.

However, I can extract the relevant information regarding the device itself and the basis of the clearance.

Here's a breakdown based on your request, with N/A for information not present in a 510(k) substantial equivalence determination:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, there are no specific "acceptance criteria" defined in the way one would for a novel device's performance study against a predefined threshold. The "performance" is based on its similarity to the predicate device and the fact that its design features, materials, chemical composition, and manufacturing are equivalent.

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance
Same fundamental scientific technology	Met
Equivalent implant materials	Met
Equivalent sterilization methods	Met
Not raising new issues of safety or effectiveness	Met (based on revised IFU)
Same Intended Use as predicate device	Met

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

Sample Size for Test Set: N/A (No specific "test set" in the context of a de novo performance study is mentioned for this substantial equivalence). The evaluation is based on comparison to the predicate device.
Data Provenance: N/A

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

Number of Experts: N/A
Qualifications of Experts: N/A

4. Adjudication method for the test set

Adjudication Method: N/A

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

MRMC Study: No, this is not an AI/AI-assisted device. It is bone cement.
Effect Size: N/A

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

Standalone Performance Study: No, this is not an AI/AI-assisted device. It is bone cement.

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

Type of Ground Truth: N/A (The "ground truth" for this submission is the established safety and effectiveness of the predicate device).

8. The sample size for the training set

Sample Size for Training Set: N/A (No "training set" in the context of an AI/ML model or a de novo performance study is mentioned).

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

Ground Truth Establishment for Training Set: N/A

Summary of what the document does provide:

Device Name: Kyphon® Xpede™ Bone Cement
Regulation Number: 21 CFR 888.3027 (Polymethylmethacrylate (PMMA) bone cement)
Regulatory Class: Class II
Product Code: NDN
Indications for Use: Treatment of pathological fractures of the vertebral body due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung cancer, lymphoma), or benign lesions (hemangioma, giant cell tumor) using cementoplasty (kyphoplasty or vertebroplasty). Pathologic fracture may include a symptomatic vertebral body microfracture without obvious loss of vertebral body height.
Predicate Device: Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011)
Basis for Clearance: Substantial equivalence to the predicate device, stating that the subject device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, design features, chemical composition, device performance, packaging, manufacturing, and that the revision/modification of the indications for use does not raise new issues of safety or effectiveness.

Summary

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

Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

Medtronic Sofamor Danek USA, Incorporated Ms. Kathy L. Remsen Senior Regulatory Affairs Program Manager 1800 Pyramid Place Memphis, Tennessee 38132

November 16, 2015

Re: K151227

Trade/Device Name: Kyphon® Xpede™ Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: September 28, 2015 Received: October 1, 2015

Dear Ms. Remsen:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

forth in the quality systems (OS) 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,

Mark N. Melkerson -S

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

Enclosure

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

Indications for Use

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

510(k) Number (if known) K151227

Device Name Kyphon® Xpede™ Bone Cement

Indications for Use (Describe)

Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty or vertebroplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

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}------------------------------------------------

KYPHON® Xpede™ Bone Cement September 2015

Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis. Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Kathy L. RemsenSenior Regulatory Affairs Program Manager
Proprietary Trade Name:	KYPHON® Xpede™ Bone Cement
Common Name:	Bone Cement
Classification Name:	Cement, bone, vertebroplasty
Product Code:	NDN
Regulation:	21 CFR 888.3027
Classification:	II

Description:

Indications for Use:

Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions

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

using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Summary of the Technological Characteristics:

The subject Kyphon® Xpede™ Bone Cement has the same fundamental scientific technology as the predicate KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The subject device utilizes equivalent implant materials and sterilization methods.

Identification of Legally Marketed Devices:

The subject Kyphon® Xpede™ Bone Cement is substantially equivalent to the predicate Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).

Conclusion:

The design features, device materials, chemical composition, device performance, packaging of the device materials, manufacturing and sterilization methods are substantially equivalent to the previously cleared Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The revision and modification of the wording in the indications for use do not raise new issues of safety or effectiveness. The indications for use statement for KYPHON® Xpede™ Bone Cement has the same Intended Use as the predicate Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).

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.”