AFT is intended for use as a bone void filler in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.

AFT is intended for single patient use only.

Device Description

AFT is composed of human demineralized bone matrix, human non-demineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.

AI/ML Overview

This 510(k) premarket notification for the AFT Allograft Filler Tube does not include detailed acceptance criteria or a dedicated study section with the type of quantitative performance data you're requesting. Instead, it relies on demonstrating substantial equivalence to predicate devices and general safety/effectiveness information.

Here's a breakdown of what is available based on your request, and where the document falls short:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Osteoconductivity	AFT is osteoconductive.
Osteoinductivity Potential	Demonstrated in an athymic mouse model. Every lot of final product will be tested for this potential.
Biocompatibility	Established through long history of safe and effective clinical use of materials, and laboratory testing per ISO 10993.
Sterility	Single-donor processed using aseptic techniques and tested per current USP <71>.
Viral Inactivation (DBM component)	DBM processing methods provide significant viral inactivation potential for a wide range of model viruses.
Viral Inactivation (CBM component)	CBM processing methods provide some viral inactivation potential for a wide range of model viruses (less than DBM, but risk of disease transmission remains low due to multiple safeguards).
Function and Intended Use	Same as predicate devices (OSTEOSET® and Exactech Resorbable Bone Paste).
New Bone Growth Support	In vivo testing in the athymic mouse model demonstrated that AFT materials can effectively support new bone growth in osseous defects.

Important Note: The document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects." This highlights that while animal data is presented, it's not considered directly predictive of human clinical outcomes for this specific aspect. There are no quantitative metrics (e.g., specific percentages, measurements of new bone formation) presented as acceptance criteria or performance results within this document.

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

Test Set Description: The document refers to "in vivo testing in the athymic mouse model" for osteoinductivity potential and new bone growth support.
Sample Size: The exact sample size ("n") for the athymic mouse model study is not provided in this document.
Data Provenance: The athymic mouse model is an animal model. The country of origin for the data is not specified, though the sponsor is in Edison, NJ, USA. The data is presented as a result of experimentation, making it prospective data within the context of the animal study.

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

This information is not provided. Given that the listed "performance" data comes from an animal model, the concept of "ground truth" derived from human clinical experts is not directly applicable in the same way as it would be for a diagnostic device. Any assessment of the animal study results would presumably be done by researchers/pathologists specializing in histology and bone biology, but their number and qualifications are not disclosed.

4. Adjudication Method for the Test Set:

This information is not provided. Again, for an animal study focused on biological endpoints, a formal clinical adjudication method (like 2+1) is typically not used in the same context as for human diagnostic device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI devices where human readers interpret medical images. The AFT Allograft Filler Tube is a bone void filler product, not a diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone (algorithm only) study was not done. This concept is also not applicable to a bone void filler. The device itself is the "algorithm" in a sense, and its performance is assessed via biological outcomes (like bone growth), not through an AI algorithm's independent interpretations.

7. Type of Ground Truth Used:

For the athymic mouse model: The ground truth would likely be based on histopathological examination (e.g., histology slides showing new bone formation, cell differentiation) and potentially radiographic analysis (e.g., assessment of bone density or defect filling in animal models). The document mentions "in vivo testing" and "osteoconductive," implying biological assays.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The AFT device is a biological product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The components (DBM, CBM, sodium hyaluronate) have an "established history of safe and effective clinical use," which could be considered analogous to a large historical dataset informing their safety, but not a "training set" for an algorithm.

9. How Ground Truth for the Training Set Was Established:

This information is not applicable/not provided for the same reasons as #8. The "ground truth" for the raw materials is their known biological and chemical properties, and their established clinical safety and effectiveness through prior research and clinical use.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence, biocompatibility, sterility, and potential for osteoinductivity/new bone growth based on animal models and an established history of safe use for its components, rather than providing quantitative performance metrics typical of a diagnostic AI device or a direct clinical trial with a defined acceptance criteria table.

Summary

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AFT 510(k) Premarket Notification

MAR 2 1 2006

K 06016/

X. 510(k) SUMMARY OF SAFTEY & EFFECTIVENESS

PROPREIETARY NAME:	AFT Allograft Filler Tube
COMMON NAME:	Bone Void Filler Containing Human DemineralizedBone Matrix (DBM)
PROPOSED REGULATORYCLASS:	Class II
CLASSIFICATIONIDENTIFICATION:	21 C.F.R. §888.3045 Resorbable calcium salt bonevoid filler device
PRODUCT CODE:	87—Orthopedic Devices
SPONSOR:	Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202

INDICATIONS FOR USE:

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE INFORMATION:

AFT shares the same function and intended use and therefore is substantially equivalent to OSTEOSET® and Exactech Resorbable Bone Paste. In vivo testing in the athymic mouse model has demonstrated that AFT materials can effectively support new bone growth in osseous defects.

Confidential

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SAFETY AND EFFECTIVENESS INFORMATION:

Biocompatibility of AFT materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. AFT is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.

OSTEOINDUCTIVITY POTENTIAL:

AFT is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse. Every lot of final product will be tested to ensure the osteoinductive potential of the final product. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.

VIRAL CLEARANCE AND INACTIVATION:

The method for processing the DBM and CBM (cortical cancellous) contained in the AFT was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses. The CBM processing methods were determined to provide some viral inactivation potential for a wide range of viruses. In comparison, the CBM processing methods provided less viral inactivation potential than the DBM processing methods; therefore, the risk of disease transmission for the CBM component is greater than the DBM component. However, the risk for disease transmission for these components remains low due to the multiple safeguards employed, i.e., donor selection, laboratory testing, and material processing.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2006

Musculoskeletal Transplant Foundation c/o Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street Edison, New Jersey 08837

Re: K060161

Trade/Device Name: AFT Allograft Filler Tube Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP Dated: December 6, 2005 Received: January 20, 2006

Dear Ms. Bennewitz:

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 for abovened as 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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 – Ms. Nancy Bennewitz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seeting your device as described in your Section 510(k) This letter will anow you to begin manies.ing of substantial equivalence of your device to a legally premits that hourication. The PDF miamig of cation 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), please If you desire specific advice for your ac not our and one one one the regulation entitled, and comact the Office of Compliance at (210) = 6 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 0 = 3 = 0 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other gelleral International on your responsibilities and 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,

Herbert Lemmerling

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: AFT Allograft Filler Tube

Indications for Use:

AFT is intended for single patient use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Pcr 21 CFR 801 Subpart D)

Over-The-Counter Use __ (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helent Lemmerts

Division of General, Restorative, and Neurological Devices

510(k) Number K060161

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.