NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.

Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA regarding the NovaBone IRM device. It details the device's indications for use, technological characteristics, and a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML device.

The document describes a medical device (bone void filler) and its regulatory clearance process, not an AI/ML system. Therefore, most of the requested information about acceptance criteria for AI algorithms, test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this document's content.

Here's how I would answer based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as inferred from a non-AI context):

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (NovaBone Putty K112773). For a traditional medical device like NovaBone IRM, the "acceptance criteria" are implicitly met by demonstrating that it is as safe and effective as the predicate device.

The performance is primarily evaluated through:

Biocompatibility: Supporting safety.
Functional in vivo results: Demonstrating performance in a rabbit femoral defect model. This shows the device's ability to resorb and be replaced by bone during the healing process, and fill osseous defects.
Technological Characteristics: Matching the composition and particle sizes to cleared devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred for this specific device):

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (from the document)
Safety: Biocompatibility	"A biocompatibility assessment for NovaBone IRM supports safety of the device for implantation in bone voids."
Effectiveness: Ability to fill bony voids	"The results of a rabbit femoral defect model further support biocompatibility and show the device performance to be substantially equivalent to NovaBone Putty (K112773) for filling of osseous defects.""Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months." (This speaks to the mechanism of action)
Technological Equivalence	"Both devices incorporate 45S5 bioactive glass in a synthetic binder that facilitates handling and are used as bone void fillers in the extremities and pelvis. The bioglass particles sizes for the proposed device are the same as the reference predicate, NovaBone Bioactive Strip (K141207)."
Resorbability & Replacement by Bone	"The product provides a bone void filler that resorbs and is replaced with bone during the healing process." (Indication for Use)

Responses to Specific Questions (Many are not applicable to this document as it's not an AI/ML device):

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implicitly those necessary to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and function as a bone void filler.
Sample sized used for the test set and the data provenance:
- The document mentions "Animal testing" and "a rabbit femoral defect model." It does not specify the precise sample size (number of rabbits) or exact data provenance beyond being an animal model. There is no "test set" in the context of an AI/ML algorithm.
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. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for this device's performance would be the biological outcome in the rabbit model (e.g., bone formation, material resorption), likely assessed by pathologists or researchers in the field, but the document does not detail this.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device relying on diagnostic interpretations.
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. This is a physical medical device, not an AI/ML system that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the animal study, the "ground truth" would be direct biological observation and analysis (e.g., histology, imaging) of the defect sites in the rabbits, which falls under "pathology" or "outcomes data" in a broad sense. The document states: "Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months." This is an outcome.
The sample size for the training set:
- Not applicable. This is not an AI/ML device; there is no "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As there's no AI training set, there's no ground truth establishment for it.

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 an abstract symbol that resembles a stylized caduceus, with three human profiles forming the shape of a bird or wing.

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

January 18, 2017

NovaBone Products, LLC % Ms. Lisa C. Simpson Consultant Simpson Regulatory Solutions, LLC 4401 NW 18th Place Gainesville, Florida 32605

Re: K163310

Trade/Device Name: NovaBone IRM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 21, 2016 Received: November 23, 2016

Dear Ms. Simpson:

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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163310

Device Name NovaBone IRM

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)

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."

FORM FDA 3881 (8/14)

{3}------------------------------------------------

510(k) Summary of Safety & Effectiveness

Image /page/3/Picture/1 description: The image shows the logo for NOVABONE. The logo is written in a sans-serif font, with the letters in teal and blue. The letter 'O' in 'BONE' is replaced with a white starburst. A registered trademark symbol is located in the upper right corner of the logo.

Date Prepared: November 19, 2016

510(k) Holder / Submitter:

NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615

Contact: Gregory Pomrink Director, R&D and RA Ph: (386) 518-6973 / Fax: (386) 462-7525 Email: gpomrink(@novabone.com

Regulatory Contact:

Simpson Regulatory Solutions, LLC 4401 NW 18 Place Gainesville, FL 32605

Contact: Lisa C. Simpson Email: regulatorysolutions(@icloud.com Ph: (352) 562-5122

Name of Device:

Trade Names:	NovaBone IRM
Common Name:	Osteoconductive Bone Void Filler SyntheticResorbable Bone Graft Material
Regulation Number:	21 CFR 888.3045 Regulation Name: Bone Void Filler
Regulatory Class:	Class II
Product Code:	MQV

Legally Marketed Predicate Devices:

K112773' NovaBone Putty MIS (primary predicate) K141207 NovaBone Bioactive Strip (reference predicate)
1 FDA clearances for NovaBone Putty product line also include K060728, K08009, K082672, K101860, K110368, and K 112773, which represent various packaging formats and indications for use changes.

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

510(k) Summary of Safety & Effectiveness

Device Description

Indications for Use

Technological Characteristics and Substantial Equivalence

The proposed NovaBone IRM device is substantially equivalent to the primary predicate, NovaBone Putty (K112773). Both devices incorporate 45S5 bioactive glass in a synthetic binder that facilitates handling and are used as bone void fillers in the extremities and pelvis. The bioglass particles sizes for the proposed device are the same as the reference predicate, NovaBone Bioactive Strip (K141207). The packaging formats for NovaBone IRM are equivalent to that of NovaBone Putty (K112773). A biocompatibility assessment for NovaBone IRM supports safety of the device for implantation in bone voids. The results of a rabbit femoral defect model further support biocompatibility and show the device performance to be substantially equivalent to NovaBone Putty (K112773) for filling of osseous defects.

Conclusion

The composite of descriptive information, biocompatibility data, functional in vivo results in the rabbit model demonstrate that the safety and performance of NovaBone IRM is substantially equivalent NovaBone Putty (K112773), when used as a bone void filler in the extremities and pelvis per the defined indications for use.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.