Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

Device Description

OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.

OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation.

OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.

AI/ML Overview

The provided text describes the OsteoVation Impact, a calcium phosphate bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device (OsteoVation® CMF Bone Void Filler, K051784) rather than establishing novel acceptance criteria for a new type of device. Therefore, the "acceptance criteria" discussed here relate to ensuring the modified device maintains performance comparable to the predicate.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format with specific numerical targets for each test, but it describes how results were evaluated against the predicate device. The performance is consistently stated as "comparable to the predicate device" or "PASS," implying that the results fell within acceptable ranges established by the predicate's performance.

Test	Test Method Summary	Acceptance Criteria (Implicit)	Reported Device Performance
Working time	Tests performed to determine the workability time of the cement, including mixing and molding of the paste.	Comparable to the predicate device.	All samples passed the targeted working time and setting strength. The test results demonstrated working time comparable to the predicate device.
Setting Time	Testing conducted to determine the Setting strength (Mean ≥ 450N and ≥ 700N) at various time points in a target temperature solution, post-sterilization after a target working time.	Mean ≥ 450N and ≥ 700N; Comparable to the predicate device.	All samples passed the targeted setting time. The test results demonstrated setting time comparable to the predicate device.
Tensile Strength	Evaluated subject device minimum tensile strength at 24 hours. Samples prepared through mortal/pestle combination into molds in varying diameters and thickness, placed in a prepared solution at 37°C for 24 hours. Tested using a mechanical testing system.	Comparable to the predicate device.	PASS. The test results demonstrated tensile strength comparable to the predicate device.
Temperature Profile	Subject device mixed and placed into a centrifuge tube and into a 37°C water bath. Temperature profile recorded at specified intervals using a computer controlled thermocouple for 24 hours.	Comparable to the predicate device.	PASS. The test results demonstrated temperature profile comparable to the predicate device.
pH Profile	Subject device mixed and placed into a centrifuge tube and into a 37°C water bath. pH recorded at specified intervals using a calibrated probe with a TC temperature compensator. Evaluates physiological characteristics.	Comparable to the predicate device.	PASS. The test results demonstrated pH profile comparable to the predicate device.
FTIR Analysis	Mix and incubate subject device for 24 hours. Dry cured sample at 37°C for 72 hours. Perform 64 scans at typical resolution of 4cm-1. Determines the formation of hydroxyapatite.	Nearly identical hydroxyapatite structure as the predicate device.	PASS. FTIR analysis show nearly identical hydroxyapatite structure as the predicate device.
Crystallographic Analysis	Analyze prepared sample using x-ray diffractometer (XRD). Perform Rietveld analysis to determine ratios of each compound in cured cement.	Comparable results as the predicate device.	PASS. XRD analysis show comparable results as the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes (number of devices, batches, or specimens) used for each bench test. It mentions "All samples" passed for working and setting time but doesn't quantify "all."

The data provenance is bench testing conducted by Skeletal Kinetics, LLC. There's no mention of country of origin for data as it's mechanical/chemical testing. The tests are prospective for the modified device to demonstrate its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

N/A. This being a bench test study for a material, there isn't a "ground truth" established by experts in the typical sense (e.g., radiologist consensus for image analysis). The "ground truth" is derived from the objective physical and chemical properties and performance of the device and its comparison to a well-characterized predicate.

4. Adjudication Method for the Test Set:

N/A. This is not applicable to bench testing of material properties. The results are physical measurements and chemical analyses, not subjective assessments 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:

N/A. This study is for a medical device (bone void filler material), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

N/A. As above, this is about a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is the established performance characteristics and material composition of the predicate device (OsteoVation® CMF Bone Void Filler, K051784). The goal of the study was to demonstrate that the modified OsteoVation Impact has comparable physical, chemical, and performance characteristics to this predicate, ensuring that the formulation change did not adversely affect its safety and efficacy.

8. The sample size for the training set:

N/A. This is not a machine learning or AI study, so there is no concept of a "training set."

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

N/A. There is no training set in this context.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.

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

January 13, 2017

Skeletal Kinetics, LLC. Alicia Hemphill Director, Regulatory Affairs 10201 Bubb Road Cupertino, California 95014

Re: K162864

Trade/Device Name: OsteoVation Impact Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: October 12, 2016 Received: October 13, 2016

Dear Ms. Hemphill:

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 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.

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

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,

Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K162864

Device Name OsteoVation® Impact

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael J. Hoffmanr

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

Image /page/3/Picture/0 description: The image shows the logo for Skeletal Kinetics. The logo consists of a blue globe-like icon on the left, followed by the text "Skeletal Kinetics" in a blue sans-serif font. Below the company name, in a smaller, lighter font, is the text "A COLSON ASSOCIATE".

510(k) SUMMARY

I. SUBMITTER

Skeletal Kinetics 10201 Bubb Road Cupertino, CA 95014 USA

Phone: 972-677-4783 Fax: 972-677-4601 Email: ahemphill@osteomed.com

Contact Person: Alicia Hemphill Date Prepared: January 12, 2017

Establishment Registration: 3003890476

II. DEVICE

Name of the Device: OsteoVation® Impact Common or Usual Name: Hydroxyapatite Cement Classification Name: Methyl Methacrylate For Cranioplasty Regulation: 882.3500 Regulatory Class: Class II Product Code: GXP

III. PREDICATE DEVICE

510(k) Number	ProductCode	Trade Name	Manufacturer
K051784	GXP	OsteoVation® CMF	Skeletal Kinetics,
Primary		Bone Void Filler	LLC.

IV. DEVICE DESCRIPTION

OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.

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

Image /page/4/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo features a blue globe-like icon on the left, followed by the text "Skeletal Kinetics" in a blue, sans-serif font. Below the company name, there is a smaller line of text that reads "A COLSON ASSOCIATE".

INDICATIONS FOR USE V.

OsteoVation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

The subject and predicate devices are classified as Methyl Methacrylate for Cranioplasty, and are intended for use in cranialbone applications. In establishing substantial equivalence to the predicate device, Skeletal Kinetics, LLC evaluated the indications for use, materials, technology, and product specifications of those products. Additionally, performance testing has been completed to demonstrate that the Osteo Vation Impact as a bone void filler in cranialbone applications is as safe, and effective, and performs as well as the legally marketed device. The performance testing and device comparison did not raise issues of safety or efficacy.

A formulation change is being made to the powder and liquid working components of the subject device in order optimize the utility of the device during implantation. Sodium phosphate (SPMA) is being added to the liquid component along with a ratio change. A ratio change is also being made to the powder component. This formulation change increases the room temperature range for the utility of the paste from 19℃ - 21℃ to 19℃ - 25℃. Verification testing of the working and setting time shows the formulation change does not affect the performance characteristics of the bone void filler.

The following technological differences exist between the subject and predicate device:

Increase in room temperature range in Instructions for Use from 19°C -● 21°C to 19°C = 25°C
Addition of sodium phosphate (SPMA) to liquid component ●
Ratio change to powder component ●

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

Image /page/5/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo features a blue circular graphic with a network pattern on the left. To the right of the graphic is the text "Skeletal Kinetics" in a blue sans-serif font. Below the text is the phrase "A COLSON ASSOCIATE" in a smaller, lighter font.

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

No biocompatibility studies were needed to demonstrate safety and efficacy.

Bench Testing

The following bench testing was conducted:

Working time and Setting Strength ●
Tensile Strength ●
Temperature Profile ●
pH Profile ●
FTIR analysis ●
Crystallographic Analysis

Test equipment

Osteovation Impact was used as indicated in Instructions for Use, Constant Temperature Water Bath (VWR, S. San Francisco, CA), Phosphate buffered saline (Sigma Chemical Co, St. Louis), Flat Plastic Spatula (Nunc, Rochester, NY), Vortexer (VWR, S. San Francisco, CA) , Mechanical Testing Machine with high load indentor (Instron, Canton, MA), Setting Test containers: Acetal (or other rigid plastic) block molds, pH meter and probe (Corning model 530 meter, model 576156 probe Corning N.Y.), Rigaku Ultima IV XRD, FTIR Spectrometer (Thermo Nicolet, Madison, WI).

Test	Test Method Summary	Results
Working time	Tests were performed to determinethe workability time of the cement.Measurements included mixingand molding of the paste.	All samples passed the targetedworking time and settingstrength.The test results demonstratedworking time comparable to thepredicate device.
Setting Time	Testing was conducted todetermine the Setting strength(Mean $\ge$ 450N and $\ge$ 700N) atvarious time points in a targettemperature solution, post-sterilization after a target workingtime.	All samples passed the targetedsetting time.The test results demonstratedsetting time comparable to thepredicate device.
Tensile Strength	Testing evaluated the subject	PASS
Test	Test Method Summary	Results
	device minimum tensile strength at24 hours.	The test results demonstratedtensile strength comparable to
	Samples were prepared throughthe mortal/pestle combination intomolds in varying diameters andthickness. Samples were placed ina prepared solution at 37°C for 24hours. Tensile strength testing isconducted using a mechanicaltesting system.	the predicate device.
TemperatureProfile	The subject device is mixed andplaced into a centrifuge tube andinto a 37°C water bath. Thetemperature profile is recorded atspecified intervals using acomputer controlled thermocouplefor 24 hours.	PASSThe test results demonstratedtemperature profile comparableto the predicate device.
pH Profile	The subject device is placedmixed and placed into a centrifugetube and into a 37°C water bath.The pH is recorded at specifiedintervals using a calibrated probewith a TC temperaturecompensator.	PASSThe test results demonstratedpH profile comparable to thepredicate device
	The test evaluates physiologicalcharacteristics of the device.
FTIR Analysis	Mix and incubate subject devicefor 24 hours. Dry cured sample at37°C for 72 hours. Perform 64scans at typical resolution of 4cm-1.This test determines the formation	PASSFTIR analysis show nearlyidenticalhydroxyapatitestructure as the predicate device
	of hydroxyapatite.
CrystallographicAnalysis	Analyze prepared sample using x-ray diffractometer (XRD). PerformRietveld analysis determine ratiosof each compound in curedcement.	PASSXRD analysis showcomparable results as thepredicate device.

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

Image /page/6/Picture/0 description: The image contains the logo for Skeletal Kinetics. The logo consists of a blue circular graphic to the left of the company name, "Skeletal Kinetics," which is also in blue. Below the company name, in smaller letters, it says "A COLSON ASSOCIATE."

Skeletal Kinetics OsteoVation® Impact Submission January 12, 2017

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Skeletal Kinetics. The logo consists of a circular graphic to the left of the text "Skeletal Kinetics". Below the text is the phrase "A COLSON ASSOCIATE" in a smaller font size.

Animal Study

No animal studies were needed to demonstrate safety and efficacy.

Clinical Studies

No clinical studies were needed to demonstrate safety and efficacy.

CONCLUSIONS VIII.

The indication for use, technological characteristics, materials, technology, and product specifications are equivalent. The performance testing conducted, demonstrate that the OsteoVation Impact as a bone void filler in cranialbone applications is as safe, and effective, and performs as well as the legally marketed device and did not raise new issues of safety or efficacy.

Differences in the subject and predicate device formulation change increases the room temperature range for the utility of the paste. Verification testing of the working and setting time shows the formulation change does not affect the performance characteristics of the bone void filler

Additional non-clinical evaluations (tensile strength, temperature profile, pH profile, FTIR analysis, crystallographic analysis) demonstrate comparable results as the test performed for the predicate device.

The conclusions drawn from the nonclinical demonstrate that the device is as safe, and effective, and performs as well as the legally marketed device.

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).