KyphX HV-R® Bone Cement is indicated for the treatment of pathological fractures of the verteral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty 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.

Device Description

KyphX HV-R® Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/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

The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a bone cement, not a study evaluating a device's performance against acceptance criteria in the context of AI/software. Therefore, it does not contain the specific information requested in the prompt, such as:

A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., for a diagnostic AI).
Sample sizes for test or training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC study details.
Standalone performance or type of ground truth for an AI device.

The document describes the KyphX HV-R® Bone Cement and focuses on its substantial equivalence to predicate devices, its intended use, and its physical/chemical properties.

It mentions a "study" in the context of "Testing was conducted to verify the KyphX HV-R® Bone Cement performance for in vivo applications in support of the labeling changes." However, this is not an effectiveness study as typically performed for AI or diagnostic devices, but rather performance testing related to the physical properties of the bone cement.

Here's what can be extracted, acknowledging the mismatch with the prompt's focus on AI/diagnostic device studies:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for clinical performance (like sensitivity or specificity) for a diagnostic device, nor does it report such performance. Instead, it mentions:

Acceptance Criteria (Implied): The device's performance (specifically handling properties like dough times and hardening times) must be within the "Setting Time specification range."
Reported Device Performance: "Handling properties (dough times) were assessed on multiple lots of bone cement, including lots that were manufactured at the extremes of the Setting Time specification range. The dough time and hardening time were also measured at various ambient temperatures using bone filler devices, the intended mode of clinical application." The conclusion drawn is that "The results of this testing support the determination of substantial equivalence."

A table formatted for the prompt's request would look like this, but with caveats:

Acceptance Criteria (for physical properties)	Reported Device Performance (for physical properties)
Within "Setting Time specification range"	Dough times and hardening times assessed; outcomes supported substantial equivalence.
	Measurements at various ambient temperatures using bone filler devices.

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

Test Set Sample Size: "multiple lots of bone cement" – specific number not provided.
Data Provenance: Not specified (e.g., country of origin). The testing is related to manufacturing and physical properties rather than clinical data from patients.
Retrospective/Prospective: Not applicable in the context of physical property testing for a bone cement.

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

Not applicable. Ground truth in this context refers to the physical properties of the cement, measured mechanically, not interpretations by human experts for diagnostic purposes.

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

Not applicable. No expert adjudication was involved for physical property measurements.

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:

No. This is a bone cement, not an AI device.

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

No. This is a physical medical device (bone cement), not an algorithm.

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

The "ground truth" for the testing mentioned would be the measured physical properties (e.g., specific dough times and hardening times) of the bone cement, determined through laboratory testing and instrumentation, compared against predefined specifications.

8. The sample size for the training set:

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

In summary, the provided document describes a 510(k) clearance for a bone cement, focusing on its substantial equivalence through physical property testing, not an AI or diagnostic device evaluation study as anticipated by the prompt's structure.

Summary

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K093828

・;

AUG 1 2 2010

PREMARKET 510(k) SUMMARY

Summary Date:	August 2010
Trade Name:	KyphX HV-R® Bone Cement
Common Name:	PMMA Bone Cement
Classification Name:	Bone Cement (21 CFR part 888.3027)
Device Code, Class:	NDN, Class II
Manufacturer's Name:Address:	Medtronic Spine LLC1221 Crossman Avenue Sunnyvale, CA 94089Establishment Registration No. 2953769
Contact Person:	Mary Rose Sr. Principal Regulatory Affairs Specialist1221 Crossman Avenue Sunnyvale, CA 94089Telephone: 408-548-5203Fax: 408-548-6501
Performance Standards:	The requirements of the Food Drug and Cosmetic Act,under section 514 for performance standards, are notapplicable to the KyphX HV-R® Bone Cement.
Predicate Devices:	K041584 KyphX HV-R® Bone CementK033801 KyphX HV-R® Bone Cement
Intended Use:	KyphX HV-R® Bone Cement is indicated for thetreatment of pathological fractures of the verteral bodydue to osteoporosis, cancer, or benign lesions using aballoon kyphoplasty procedure. Cancer includes multiplemyeloma and metastatic lesions, including those arisingfrom breast or lung cancer, or lymphoma. Benign lesionsinclude hemangioma and giant cell tumor.

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Device Description:	KyphX HV-R® Bone Cement is provided as a two-component system. The powder component consists of aPMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate asa radiopacifier and benzoyl peroxide as an initiator. Theliquid component consists of methylmethacrylatemonomer, with the addition of hydroquinone as astabilizer and N,N-dimethyl-p-toluidine as a promoter.The powder and liquid components are mixed prior touse.
Sterilization:	KyphX HV-R® Bone Cement is provided sterile. KyphXHV-R® Bone Cement is intended for single-use only.
Substantial Equivalence:	Testing was conducted to verify the KyphX HV-R® BoneCement performance for in vivo applications in supportof the labeling changes. Handling properties (doughtimes) were assessed on multiple lots of bone cement,including lots that were manufactured at the extremes ofthe Setting Time specification range. The dough time andhardening time were also measured at various ambienttemperatures using bone filler devices, the intendedmode of clinical application.
	The results of this testing support the determination ofsubstantial equivalence. Therefore, it is concluded thatthe modified KyphX HV-R Bone Cement is substantiallyequivalent to the predicate KyphX HV-R Bone Cement.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

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

AUG 1 2 2010

Medtronic Spine LLC % Ms. Mary Rose Sr. Principal Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089

Re: K093828

Trade/Device Name: KyphX HV-R® Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: July 28, 2010 Received: July 30, 2010

Dear Ms. Rose:

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.

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Page 2 - Ms. Mary Rose

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please, go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,
Mark A. Milkeron

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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AUG - 1 - 2 - 2010

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: KyphX HV-R® Bone Cement

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamee W. Linge

(Divisi Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K093828

Page ___ of __________________________________________________________________________________________________________________________________________________________________

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.”