Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP 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–TCP Bone Graft Substitute is a porous calcium phosphate resorbable 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-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Apatight-TCP Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

AI/ML Overview

The provided 510(k) summary is for Apatight-TCP Bone Graft Substitute, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria related to diagnostic performance.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or extractable from this document as it's not a diagnostic device and doesn't involve AI or image analysis.

However, I can extract the information relevant to the device's performance based on the substantial equivalence paradigm, focusing on a pre-clinical animal study.

Here's an attempt to fill out the table and answer the questions based on the provided text, noting where information is not applicable (N/A) or not provided (NP).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Predicate Device Performance / Expected Outcome	Reported Device Performance (Apatight-TCP)
Biocompatibility	Well-tolerated, no inflammation/infection	"well-tolerated"
Osteoconductivity / Bone Integration	Bone ingrowth into pores and integration with host bone	"completely integrated into the defect site," "interconnected porosity... completely filled with new bone at the follow-up time points"
Resorption & Replacement	Resorbs and is replaced by bone	"The product resorbs and is replaced with bone during the healing process." (from intended use statement, confirmed by "As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute." in device description, and implied by bone filling and integration in animal study).
Mechanical Stability (implied)	Not intrinsically unstable	Indicated for "bony voids or gaps that are not intrinsic to the stability of the bony structure." Performance implies it doesn't cause instability.
Chemical Composition	Standard for implantable tricalcium phosphate	"The material chemical composition also satisfies an ASTM standard for implantable tricalcium phosphate."
Similar Intended Use	Similar to predicate device	"nearly identical in intended use" to the predicate device.
Similar Materials	Similar to predicate device	"equivalent in materials" to the predicate device.
Similar Configuration	Similar to predicate device	"equivalent in... configuration" to the predicate device.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "performance testing in an animal model."

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

Sample size used for the test set: Not explicitly stated as a numerical sample size (e.g., number of animals). The text only refers to "an animal model" and "any Apatight-TCP treated animal."
Data provenance: Prospective animal study. Country of origin not specified, but the submission is to the U.S. FDA.

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

Number of experts: Not applicable/Not provided. This was an animal study evaluating direct biological outcomes, not an interpretation of data by human experts for ground truth establishment in a diagnostic context.
Qualifications of those experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable/Not provided. This refers to consensus among human readers for diagnostic ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC study: No, this was not an MRMC study. This device is a bone graft substitute, not an AI diagnostic tool, so such a study design is not applicable.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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

Standalone performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Type of ground truth: Histopathology/In-vivo biological observation from the animal model. The study observed "no signs of inflammation or infection," defects "completely integrated," and "pores completely filled with new bone."

8. The Sample Size for the Training Set

Sample size for the training set: Not applicable. This is a medical device, not a machine learning model, so there is no training set in the AI sense.

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

How ground truth for the training set was established: Not applicable.

Summary

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Kolz966 V

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

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-TCP Bone Graft Substitute
Common / Usual Name	Bone Void Filler, Bone Graft Substitute
Classification Name	Filler, Calcium Sulfate Preformed Pellets
Equivalent Device	Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler

Device Description

Intended Use / Indications

Substantial Equivalence Comparison

Apatight-TCP was shown by analysis of available information to be nearly identical in intended use and equivalent in materials and configuration to the predicate device. The material chemical composition also satisfies an ASTM standard for implantable tricalcium phosphate. 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-TCP 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-TCP treated animal. The information presented demonstrated that the Apatight-TCP 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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2002

James J. Cassidy, Ph.D. President CERAbio, LLC Technology Center N4660 1165th St. Prescott, Wisconsin 54021-7644

Re: K013966

Trade Name: Apatight-TCP 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichensity of to de rioss 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 controls providents or a 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 Wr ), it may of backed 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 mean that 127 man interes and regulations administered by other Federal agencies. or the Act of any I outhal 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 instille (s 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 - James J. Cassidy, Ph.D.

This letter will allow you to begin marketing your device as described in your Section The receiven will at the FDA finding of substantial equivalence of your device s ro(t) premainteted 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 yours,

Miriam C. Provost

for 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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Attachment 1

INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K013966

Device Name: Apatight™-TCP Bone Graft Substitute

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Division of General, Restorative and Neurological Devices

510(k) Number: K013966

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.