Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Device Description

Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-HA Bone Graft Substitute guides the threedimensional regeneration of bone in the defect site into which it is implanted. When Apatight-HA Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a bone graft substitute, Apatight™-HA. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/CADe device. Therefore, much of the requested information regarding AI/CADe study design (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and a description of the study used to claim equivalence for this medical device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (as demonstrated by testing)
Intended Use Equivalence: Identical to the predicate device.	Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (extremities, spine, pelvis), including surgically created or traumatic defects. This matches the intended use of the equivalent predicate device.
Material Equivalence: Equivalent in materials to the predicate device and satisfies ASTM standards for implantable hydroxyapatite.	Apatight-HA is an osteoconductive porous hydroxyapatite bone graft substitute. The material satisfies an ASTM standard for implantable hydroxyapatite. The submission states the device is "identical in intended use and equivalent in materials and configuration to the predicate device" (Pro Osteon 500R Resorbable Bone Graft Substitute).
Configuration Equivalence: Equivalent in configuration to the predicate device.	Apatight-HA is a porous implant with a trabecular structure resembling human cancellous bone, provided sterile in block and granular forms. This configuration is stated to be equivalent to the predicate device.
Biocompatibility/Integration: Well-tolerated, completely integrated into the defect site, new bone growth, no inflammation or infection. This mirrors the expected performance of the predicate device for successful bone graft substitutes.	Results of performance testing in an animal model showed that the device was well-tolerated and completely integrated into the defect site. The interconnected porosity of the Apatight-HA implants was completely filled with new bone at the follow-up time points and there were no signs of inflammation or infection in any Apatight-HA treated animal. This indicates successful osteoconduction and host response as expected from the predicate device.

Since this is a 510(k) submission for a bone graft substitute and not an AI/CADe device, the following points are largely not applicable or information cannot be extracted from the provided text.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document mentions "performance testing in an animal model," but does not specify the sample size of animals or their origin. It's a non-human biological study.
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):
- N/A. Ground truth for animal model performance would typically be established by veterinary pathologists or histologists, but the number and qualifications are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are relevant for interpreting human diagnostic imaging or clinical data, not typically for animal model histopathology unless multiple pathologists were involved in a blinded review (not specified here).
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 is not an AI device, so an MRMC study comparing human readers with AI assistance is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study, the ground truth would be based on histopathology and observation of tissue integration (new bone formation, absence of inflammation/infection). The text states "completely integrated into the defect site" and "completely filled with new bone," which implies histological analysis.
The sample size for the training set:
- N/A. There is no training set for an AI algorithm.
How the ground truth for the training set was established:
- N/A. There is no training set for an AI algorithm.

Summary

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K013960

Page 4 of 13

2 510(k) Summary [as required by 21 CFR 807.92(c)]

Submitter's Name / Contact Person

CERAbio, LLC Technology Center N4660 1165th St. Prescott, WI 54021-7644 Contact James J. Cassidy, President

General Information

Trade Name	Apatight™-HA Bone Graft Substitute
Common / Usual Name	Bone Void Filler, Bone Graft Substitute
Classification Name	Filler, Calcium Sulfate Preformed Pellets
Equivalent Devices	Pro Osteon 500R Resorbable Bone Graft Substitute (Interpore Cross,K990131, K980817)

Device Description

Intended Use / Indications

Substantial Equivalence Comparison

Apatight-HA was shown by analysis of available information to be identical in intended use and equivalent in materials and configuration to the predicate device. The material also satisfies an ASTM standard for implantable hydroxyapatite. Results of performance testing in an animal model showed that the device was well-tolerated and completely integrated into the defect site. The interconnected porosity of the Apatight-HA implants was completely filled with new bone at the follow-up time points and there were no signs of inflammation or infection in any Apatight-HA treated animal. The information presented demonstrated that the Apatight-HA Bone Graft Substitute is substantially equivalent to the currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.

MAY 2 3 2002

James J. Cassidy, Ph.D. President CERAbio, LLC Technology Center N4660 116510 St. Prescott, Wisconsin 54021-7644

Re: K013960

Trade Name: Apatight-HA Bone Graft Substitute Regulatory Class: unclassified Product Code: MQV Dated: March 21, 2002 Received: March 22, 2002

Dear Dr. Cassidy:

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 approvisions 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 (1 m 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 and noung (2) 00 regulation the quality systems (QS) regulation (21 CFR Part 820); and if roquirelies as bettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - James J. Cassidy, 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.

L. Mach A. Melleman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

4013960 510(k) Number (if known):

Apatight™ - HA Bone Graft Substitute Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Millam
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K013960

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.