The Innovasis« Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The single use devices are a variety of low profile plates and anchoring screws that fixate bone pieces together in the cranial area of the patient. The design features include:

· Commercially Pure Titanium or 6 Al 4V Titanium Alloy
· Straight and Square plates
· Double Y plates
Burr hole plates
· Plates with Shunts
· Self-Drilling/Self-Tapping Screws
Mesh
· Instrumentation to customize size, shape and placement of implants
· Compact sterilization tray to optimize organization of implants

AI/ML Overview

The provided document describes the Innovasis Cranial System, a medical device for cranial surgery and reconstructive procedures. It details the device's technical characteristics, comparison with a predicate device, and performance data from non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as numerical thresholds that were predefined and then met. Instead, it presents performance testing where the subject device (Innovasis Cranial System) was compared against a legally marketed predicate device (Jeil Medical Products LeForté Neuro System). The "acceptance criteria" implicitly used is that the subject device's performance should be equal to or exceed the predicate device's performance for the tested parameters.

Test	Implicit Acceptance Criteria	Reported Device Performance (Innovasis Cranial System)
Material	Comparable or equivalent to predicate device material specifications (ASTM F67 Commercially Pure Grade 2/3 Titanium, ASTM F136 6Al4V Titanium).	Uses ASTM F67 Commercially Pure Grade 2 Titanium (plates), Grade 3 Titanium (mesh) and ASTM F136 6Al4V Titanium for Surgical Implants (Screws). (Generally comparable, with predicate offering additional grades).
Torsion Properties	The mean torsional strength of the subject screws should be equivalent to or exceed the predicate screws.	Exceeded: "The mean torsional strength for the subject screws exceeded the strength of the predicate screws thereby demonstrating substantial equivalence."
Static Axial Pullout	The mean pullout force of the subject screws should be equivalent to or exceed the predicate screws.	Exceeded: "The mean pullout force for the subject screws exceeded the pullout force of the predicate screws thereby demonstrating substantial equivalence."
Static Axial Compression	The mean bending stiffness, Peak Force, and Displacement at deformation of the subject plate should be equivalent to or exceed the predicate plate.	Exceeded: "The mean bending stiffness, Peak Force and Displacement at deformation of the Rev. 3 subject plate exceeded the bending stiffness, Peak Force and Displacement at deformation of the predicate plate demonstrating substantial equivalence."
Static 3 Point Bend	The mean bending stiffness of the subject plates should meet or exceed the bending stiffness of the predicate plate.	Met or Exceeded: "The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence."
Static 4 Point Bend	The mean bending stiffness of the subject plates should meet or exceed the bending stiffness of the predicate plate.	Met or Exceeded: "The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence."
Corrosion	The corrosion resistance of the subject plates should meet or exceed the corrosion resistance of the predicate plate.	Met or Exceeded: "The data show the corrosion resistance of the subject plates met or exceeded the corrosion resistance of the predicate plate thereby passing the requirement in the protocol and demonstrating substantial equivalence."
Biocompatibility	Biocompatibility evaluation conducted per FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Components should be made of known biocompatible materials, and manufacturing process should not add contamination. Test results (Pyrogen, Cytotoxicity) below cutoff.	Passed: "The implants are composed of known biocompatible material... Testing was conducted to ensure manufacturing process did not add contamination. Test battery included Pyrogen Testing (LAL) and Cytotoxicity testing (MEM) All test results were below cutoff (pass)." (Demonstrating substantial equivalence).

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

The document provides the testing standards (e.g., ASTM F543-13, F382-99, F2129-08) for each performance test. It mentions "subject and predicate sample groups were tested identically" and refers to "very small screw samples" for torsion testing. However, specific sample sizes (n-values) for each test set are not explicitly stated. The data provenance for these non-clinical tests is generally within a laboratory setting, not related to patient data. The document does not specify country of origin for the data, but the submission is to the U.S. FDA. These are laboratory-based, non-clinical tests.

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

This information is not applicable as the described performance study is non-clinical (laboratory-based mechanical and material testing), not an AI or diagnostic device study involving expert assessment of patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. There is no human adjudication for mechanical or material performance tests.

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

This information is not applicable. This document describes the clearance of a physical medical implant (cranial system), not an AI or diagnostic device that assists human readers.

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

This information is not applicable as the device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is based on established engineering standards and measurements. For example:

Mechanical Properties: Measured physical strength (torsional strength, pullout force, bending stiffness, peak force, displacement at deformation) directly obtained from standardized testing methods (e.g., ASTM).
Corrosion Resistance: Measured electrical potential or current, or visual assessment under a microscope, following ASTM standards.
Biocompatibility: Results of standardized in-vitro (e.g., LAL, MEM cytotoxicity) assays and assessment of material composition against known biocompatible materials.

The "ground truth" is thus rooted in direct physical and chemical measurements against industry-recognized benchmarks and comparative performance to a predicate device.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, one behind the other. The figures are connected by a flowing ribbon-like shape.

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

November 7, 2014

Innovasis, Inc. Marshall McCarty Director QA/RA 614 E. 3900 South Salt Lake City, Utah 84107

K141644 Trade/Device Name: Innovasis Cranial System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: October 8, 2014 Received: October 9, 2014

Dear Mr. McCarty,

Re:

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

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

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,

Carlos L. Pena -5)/△

Carlos L. Peña, PhD, MS 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) K141644

Device Name Innovasis Cranial System

Indications for Use (Describe)

The Innovasis Cranial System is intended for use in selective trauma of cranial surgery and reconstructive procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in a bold, sans-serif font. Below the main logo, there is a tagline that reads "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo appears to be for a company that focuses on innovation and invention.

510(k) Summary

l. Submitter: Innovasis, Inc. 614 E. 3900 South Salt Lake Citv. UT 84107
- Contact: Marshall C. McCarty Phone: (801) 261-2236 Fax: (801) 261-3758 mmccarty@innovasis.com

Date Prepared: November 7, 2014

II. Device

Name of Device:	Innovasis® Cranial System
Common or Usual Name:	Bone Plate, Bone Screw for Cranial Fixation

Classification: Regulation No.: 21 CFR 882.5320 Class 2, Product Code: GWO Regulation No.: 21 CFR 882.5360 Class 2, Product Code: HBW Regulation No.: 21 CFR 882.5250 Class 2, Product Code: GXR

III. Predicate Device

Jeil Medical Products LeForté Neuro System Bone Plate K112812 This predicate has not been subject to a design-related recall.

IV. Device Description:

· Commercially Pure Titanium or 6 Al 4V Titanium Alloy
· Straight and Square plates
· Double Y plates
Burr hole plates
· Plates with Shunts
· Self-Drilling/Self-Tapping Screws
Mesh
· Instrumentation to customize size, shape and placement of implants
· Compact sterilization tray to optimize organization of implants

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

Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in bold, sans-serif font. The "A" in "INNOVASIS" is stylized to look like a triangle with a line extending from the top right corner. Below the main logo, in a smaller font, are the words "INNOVATE / INVOLVE / INVENT".

V. Indications for Use

The Innovasis® Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

VI. Comparison of Technological Characteristics with the Predicate Device

	Innovasis® ICS	Jeil LeForté Neuro System
Indications	The Innovasis® Cranial System is intended for usein selective trauma of cranial skeleton, cranialsurgery and reconstructive procedures.	The Leforté Neuro System is intended for use inselective trauma of cranial skeleton, cranial surgeryand reconstructive procedures.
Material	ASTM F67 Commercially Pure Grade 2 Titanium(plates), Grade 3 Titanium (mesh) and ASTM F1366AI4V Titanium for Surgical Implants (Screws)	ASTM F67 Commercially Pure Grade 2 Titanium(plates), Grade 3 Titanium (mesh) and ASTM F1366AI4V Titanium for Surgical Implants (Screws)Additional plates offered in ASTM F67 Grade 1 and 3
Features	Straight and Square platesDouble Y platesBurr hole platesPlates with ShuntsSelf-Drilling/Self-Tapping ScrewsMeshInstrumentation to customize size, shape andplacement of implants	Straight and Square platesDouble Y platesBurr hole platesPlates with ShuntsSelf-Drilling/Self-Tapping ScrewsMeshGap, Curved, X-shape, Y, Quad and Calvarium platesInstrumentation to customize size, shape andplacement of implants
Dimensions	Plates Straight, Double Y and Square, 2, 4, 6 and12 holes; Burr hole plates 6 holes 15mm diameter,5 holes 15mm, 6 holes 22mm and 5 holes 22mm.All plates and mesh are 0.648 +/-0.025mmMesh 98mm x 98mmScrews: 1.6 x 3mm, 1.6 x 4mm, 1.6 x 5mm, 1.9 x4mm	Plates Straight, Double Y and Square, 2, 4, 6 and 12holes; Burr hole plates 6 holes 15mm diameter, 5holes 15mm, 6 holes 22mm and 5 holes 22mm.Mesh 98mm x 98mmAbove plates and mesh are 0.62mmAdditional plates and mesh offered in thickness 0.3 to0.5mm, including Gap Plates (3 sizes)Curved, X-shape, Quad and Calvarium plates areoffered in other Jeil LeForté configurationsScrews: 1.6 x 3mm, 1.6 x 4mm, 1.6 x 5mm, 1.9 x4mm2.2 x 5mm and 1.4 x 1.9mm screws are offered inother Jeil LeForté configurations.
Surface	Plate: Electropolish	Plate: Anodized
Treatment	Screw: N/A	Screw: N/A
Sterilization	Sold Non-Sterile to beSteam Sterilized	Sold Non-Sterile to beSteam Sterilized

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

Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the company name in bold, sans-serif font. Below the company name is the tagline "Innovate / Involve / Invent" in a smaller font size.

VII. Performance Data

(Non-clinical)—Performance testing per ASTM F543-13, F582-99 for 3 point bend (or 4 point bend), axial compression, foam axial pullout, and torque to failure and F2129-08 for corrosion support the safety of the subject devices and demonstrate that the Innovasis Cranial System devices should perform as intended in the specified use conditions.

Test	Test Method Summary	Results
TorsionProperties	ASTM F543-13 The torsional testing of the bone screwswas performed by hand as these were very small screwsamples. Both subject and predicate sample groupswere tested identically so comparisons could be madeaccurately.	The mean torsional strength for the subject screwsexceeded the strength of the predicate screwsthereby demonstrating substantial equivalence.
Static AxialPullout	ASTM F543-13	The mean pullout force for the subject screwsexceeded the pullout force of the predicate screwsthereby demonstrating substantial equivalence.
Static AxialCompression	A domed superior test load applied to center ofspecimen to measure Stiffness, Peak Force, andDisplacement at Peak Force.	The mean bending stiffness, Peak Force andDisplacement at deformation of the Rev. 3 subjectplate exceeded the bending stiffness, Peak Forceand Displacement at deformation of the predicateplate demonstrating substantial equivalence.
Static 3 PointBend	ASTM F382-99 (08) Three-point bend instead of four-point bend testing was performed on the predicate andsubject double "Y" samples due to their shortenedlength. Comparisons between the two groups could stillbe made to determine equivalence.	The mean bending stiffness of the subject plates metor exceeded the bending stiffness of the predicateplate demonstrating substantial equivalence.
Static 4 PointBend	ASTM F382-99 (08)	The mean bending stiffness of the subject plates metor exceeded the bending stiffness of the predicateplate demonstrating substantial equivalence.
Corrosion	ASTM F2129-08	The data show the corrosion resistance of thesubject plates met or exceeded the corrosionresistance of the predicate plate thereby passing therequirement in the protocol and demonstratingsubstantial equivalence.
Biocompatibility	A biocompatibility evaluation for the ICS implants wasconducted in accordance with the FDA Blue BookMemorandum #G95-1 "Use of International StandardISO-10993, 'Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing," May 1, 1995, andInternational Standard ISO 10993-1 "BiologicalEvaluation of Medical Devices -Part 1: Evaluation andTesting Within a Risk Management Process," asrecognized by FDA.	The implants are composed of known biocompatiblematerial [ASTM F67 Commercially Pure Titanium(plates and mesh) and ASTM F136 6Al4V Titaniumfor Surgical Implants (Screws)]. Testing wasconducted to ensure manufacturing process did notadd contamination. Test battery included PyrogenTesting (LAL) and Cytotoxicity testing (MEM) All testresults were below cutoff (pass).

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

Image /page/6/Picture/0 description: The image shows the word "INNOVASIS" in bold, black letters. The "A" in the word is stylized with a line going through it. Below the word "INNOVASIS" are the words "INNOVATE / INVOLVE / INVENT" in a smaller font size.

VIII. Conclusions

The Innovasis Cranial System has been subjected to risk analysis, engineering analysis and testing to recognized standards. The predicate device, K112812 LeForte Neuro System was cleared based on the results of non-clinical data. In consideration of the following evaluated parameters subject and predicate device performance data were compared to support the safety of the subject devices:

· Design configurations
· Applied mechanical loads
· Product sizes and shapes
· Materials used
· Biocompatibility requirements
· Manufacturing and processing methods
Shelf life

The evaluations demonstrate that the Innovasis Cranial System devices should perform as intended in the specified use conditions.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).