OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

Device Description

OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

AI/ML Overview

This document is a 510(k) premarket notification for the OsteoVation™ CMF Bone Void Filler. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a new clinical study. Therefore, most of the requested information about acceptance criteria, specific study design, and performance metrics is not present in this document.

Here's an breakdown of what is available and what is not:

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

Not Applicable/Not Provided: This 510(k) is based on substantial equivalence to predicate devices (Callos Bone Void Filler and Callos CMF Bone Void Filler), not on meeting specific, defined acceptance criteria from a new clinical study for performance. The "performance" being demonstrated here is primarily the equivalence of the modified material to the predicate, ensuring it doesn't negatively impact safety or efficacy. No numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical properties with acceptance thresholds) are listed as they would be for a new device requiring de novo authorization or a PMA.

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

Not Applicable/Not Provided: No clinical "test set" in the context of an algorithm or diagnostic device performance evaluation is described. The submission focuses on material modification and substantial equivalence.

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/Not Provided: As there is no "test set" and no evaluation of an algorithm's diagnostic performance, there is no mention of experts establishing ground truth.

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

Not Applicable/Not Provided: There is no "test set" or diagnostic performance evaluation described which would require an adjudication method.

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/Not Provided: This device is a bone void filler, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant.

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

Not Applicable/Not Provided: This device is a medical implant, not an algorithm.

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

Not Applicable/Not Provided: Ground truth in the context of diagnostic accuracy is not relevant to this type of device submission. The "truth" being established is that the modified device is substantially equivalent to existing, cleared devices in terms of its safety and efficacy for its intended use. This is typically established through a combination of bench testing, biocompatibility studies, and comparisons to predicate device characteristics.

8. The sample size for the training set

Not Applicable/Not Provided: There is no "training set" as this is not an AI/algorithm device.

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

Not Applicable/Not Provided: This is not relevant to the device.

Summary regarding Acceptance Criteria and Study:

The document describes a Special 510(k) submission (K051784) for the OsteoVation™ CMF Bone Void Filler.

The "study" or justification for clearance is based on demonstrating substantial equivalence to existing predicate devices (Callos Bone Void Filler K051123; Callos CMF Bone Void Filler K042072).

Acceptance Criteria (Implied): The implied "acceptance criteria" for this 510(k) is that the modified OsteoVation CMF Bone Void Filler is substantially equivalent to its predicate devices in terms of:
- Indications for use (which remained the same)
- Technology
- Principle of operation
- Packaging
- Sterilization parameters
- Safety and effectiveness (despite a material modification, the submission asserts it is not a substantial change and does not significantly affect safety or efficacy).
The "Study" / Justification: The document states:

"This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s."

"OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation."

This type of submission relies on comparison to a legally marketed predicate, rather than generating new clinical data to meet predefined performance metrics. The FDA's clearance letter confirms this by stating they have "determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, the "study" is a comparison to predicate devices, and the "acceptance criteria" is that the modified device maintains substantial equivalence to those predicates.

Summary

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K051784

JUL 20 2005

510(k) Summary

Skeletal Kinetics, LLC OsteoVation™ CMF Bone Void Filler

General Information
Submitters Name/Address:	Skeletal Kinetics10201 Bubb RoadCupertino, CA 95014
Establishment Registration Number:	3003890476
Contact Person:	Duran YetkinlerVice President, Product Developmentand Regulatory Affairs
Phone Number:	(408) 366.5002
Date Prepared:	June 30, 2005
Device Description
Trade Name:	OsteoVation CMF Bone Void Filler
Generic/Common Name:	Hydroxyapatite Cement
Classification Name:	84 GXP
Predicate Devices
Callos Bone Void FillerCallos CMF Bone Void Filler	K051123; cleared on June 3, 2005K042072; cleared on Sept. 16, 2004

Product Description

OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

Intended Use

OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

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Substantial Equivalence

This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s.

Summary of Safety and Effectiveness

OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, rendered in a simple, abstract design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 2005

Duran Yetkinler, M.D. Ph.D. Vice President, Product Development and Regulatory Affairs 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Skeletal Kinetics, LLC 10201 Bubb Road Cupertino, California 95014

Re: K051784

Trade/Device Name: OsteoVation™ CMF Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: FWP, GXP Dated: June 30, 2005 Received: July 1, 2005

Dear Dr. Yetkinler:

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 - Duran Yetkinler, M.D. Ph.D

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/dsma/dsmamain.html

Sincerely yours,

Erik. Th

Miriam C. Provost, Ph.D 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)

OsteoVation™ CMF Bone Void Filler Device Name:

Indications for use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

Signature

on of General, Restorative rolos

J2C(c) Number K051784

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).