Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

The Vertefix™ Vertebroplasty Procedure Set contains the Vertebroplasty Injector Kit and Vertefix™ Radiopaque Bone Cement. The bone cement consists of two separate, premeasured sterilized components: 20g polymer powder and 9.2g liquid monomer. The powder contains 30% barium sulfate as a radiopacifier.

AI/ML Overview

This 510(k) submission for the Vertefix™ Vertebroplasty Procedure Set focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software medical device.

Therefore, many of the requested details, such as specific acceptance criteria, a test set with expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document. This submission primarily relies on non-clinical testing to demonstrate that the device meets existing standards for bone cement.

Here's the information that can be extracted or deduced from the provided text, with clarifications where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a bone cement device, the "acceptance criteria" are not reported as quantitative performance metrics for disease detection or classification, as would be expected for an AI device. Instead, they are related to material properties and clinical equivalence. The document states:

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence	Device is similar to predicate devices regarding intended use, chemical composition, and fundamental scientific technology.	"any differences that may exist do not significantly affect the safety and effectiveness of the device."
Material Properties	General requirements for material and chemical integrity.	"material and chemical analyses" demonstrating conformance.
Mechanical Strength	Appropriate mechanical properties for bone cement.	"mechanical testing" demonstrating conformance.
Biocompatibility	Safe for biological interaction.	"biocompatibility" testing demonstrating conformance.

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

Sample Size: Not applicable. This submission doesn't describe a clinical study with a "test set" in the context of an AI/software device evaluating patient data. The "testing" refers to benchtop and laboratory tests on the bone cement itself.
Data Provenance: Not applicable. The data provenance would be from laboratory and benchtop studies, not patient data from specific countries or types of studies.

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

Number of Experts: Not applicable. There is no "ground truth" derived from experts on patient data described in this submission.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no test set of patient cases requiring adjudication.

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-assisted device.
Effect Size: Not applicable.

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

Standalone Performance: No. This is not an AI algorithm.

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

Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this device would be established by validated engineering standards, chemical analyses, and biomechanical testing protocols for bone cements.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Ground Truth for Training Set: Not applicable.

Summary of the Study (Non-Clinical Test Data):

The study described is a series of non-clinical tests designed to demonstrate the safety and effectiveness of the Vertefix™ Radiopaque Bone Cement.

Tests Conducted: Material and chemical analyses, mechanical testing, and biocompatibility testing.
Purpose: To provide reasonable assurance that the device conforms to the requirements for its use as a bone cement and is substantially equivalent to legally marketed predicate devices (Stryker Spineplex™ Radiopaque Bone Cement and Kyphon KyphX® HV-R Bone Cement Model C01A).
Conclusion: The tests support the claim of substantial equivalence and that "any differences that may exist do not significantly affect the safety and effectiveness of the device."

This document focuses on the regulatory pathway for a conventional medical device (bone cement) based on its physical and chemical properties and comparison to existing products, rather than the performance evaluation of a software-based or AI-driven diagnostic/therapeutic system.

Summary

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K 04269//

NOV - 8 2005

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com

510(k) SUMMARY

Submitted By:	COOK INCORPORATED750 Daniels Way, P.O. Box 489Bloomington, IN 47402-0489
Contact Person:	Earl E. Knight III, MPATel: (812) 339-2235 Fax: (812) 332-0281
Date Prepared:	September 28, 2004
Device:
Trade Name:	Vertefix™ Vertebroplasty Procedure Set
Common/Usual Name	Filler, Bone Cement (For Vertebroplasty)
Proposed Classification:	Polymethylmethacrylate (PMMA) Bone Cement21 CFR §888.3027, Class II
Product Code/Panel Code:	NDN—Orthopedic

Intended Use:

Predicate Devices:

Manufacturer	Device Name	510(k) #
Stryker Corp.	Spineplex™ Radiopaque Bone Cement	K032945
Kyphon, Inc.	KyphX® HV-R Bone Cement Model C01A	K041584

Device Description:

Substantial Equivalence:

The subject device is similar with respect to intended use, chemical composition, and fundamental scientific technology of commercially available predicate devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and effectiveness of the device.

Non-Clinical Test Data:

The results of these tests provide reasonable assurance that Vertefix™ Radiopaque Bone Cement has been designed and tested to assure conformance to the requirements for its use as a bone cement. Testing conducted on the device includes: material and chemical analyses, mechanical testing, and biocompatibility,

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Thalia Brine Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-1379

Re: K042691

Trade/Device Name: Vertefix™ Vertebroplasty Procedure Set Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 4, 2005 Received: October 6, 2005

Dear Ms. Brine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Thalia Brine

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson STA Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): __ K C+ 乙 bq ) =====================================================================================================================================

Device Name: Vertefix™ Vertebroplasty Procedure Set

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_LCG & CLC

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.”