ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is intended 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.

Device Description

ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.

ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing sclution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

AI/ML Overview

The provided document is a 510(k) summary for ALLOMATRIX® Putty, a bone void filler. It describes the device, its intended use, and substantial equivalence information based on materials data and testing results. However, it does not contain a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML-based medical devices or comparative clinical trials.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

Osteoinductivity Potential: In-vitro bioassays and in-vivo rat muscle pouch studies to show the DBM component is osteoinductive.
Viral Inactivation Validation: Testing of the processing method to ensure viral inactivation.
Product Performance Testing: A comparison of radiographic outcomes and adverse event profiles to a predicate device, and evaluation in a canine model.

Therefore, many of the requested categories for a study demonstrating acceptance criteria cannot be filled from this document as it's not a performance study in that context.

Here's an attempt to extract relevant information and note what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) are not defined in the way they would be for a diagnostic AI device. The "performance" is described qualitatively in relation to the predicate device and fundamental material properties.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Substantial Equivalence	Demonstrates safety and effectiveness comparable to a predicate device.	"ALLOMATRIX® Putty was found to be substantially equivalent to the predicate device. The safety and effectiveness of ALLOMATRIX® Putty is adequately supported by the substantial equivalence information, materials data, and testing results provided..." "There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device."
Osteoinductivity	DBM component must exhibit osteoinductive potential.	In-vitro bioassay (Saos human osteosarcoma cells) showed a correlation coefficient of 0.850 (p<0.0005) with in-vivo athymic rat muscle implantation. Clinical results using DBM with >0.20 osteoinductivity index showed 92% healing vs. 33% for ≤0.20. ALLOMATRIX® Putty was found to be osteoinductive in vivo in the rat muscle pouch model. Each lot is assayed.
Viral Inactivation	Processing method must demonstrate suitable viral inactivation potential for a panel of human viruses.	Testing demonstrated "suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses."
Clinical Performance	Radiographic outcomes and adverse event profiles comparable to predicate device.	"There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device."
Biocompatibility/Safety	Compatible with biological systems (implied by material composition and predicate comparison).	(Implicit, no specific test results on biocompatibility explicitly stated beyond adverse events and material data.)
Handler/Placement	Able to be gently packed into bony voids.	"After the powder is hydrated...the resultant putty can then be handled and placed in the appropriate bone voids." (Stated as a property, not a measured performance criterion).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Osteoinductivity in-vitro/in-vivo correlation: "99 of 101 donor lots" were accurately predicted for in-vivo osteoinductivity. This implies a sample size of 101 DBM donor lots. Data provenance not specified (likely US, given the submission location).
Clinical results (DBM healing): Not explicitly stated, but "clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing" suggests a patient cohort. Sample size for these clinical results is not provided in this document. Data provenance is not specified.
Product Performance Testing (Clinical): Comparison "compared to the predicate device" implies a retrospective analysis of clinical outcomes from existing data or literature. No sample size, country of origin, or study design (retrospective/prospective) is provided.
Product Performance Testing (Canine Model): A canine model was used. Specific sample size (number of canines or defects) is not provided.

3. 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 in the context of this 510(k) for a bone void filler. The "ground truth" here relates to biological activity (osteoinductivity) and clinical outcomes, not expert interpretation of diagnostic images.
Radiographic evaluations would likely be performed by physicians, but no details are provided about the number or qualifications of clinicians assessing the "radiographic outcomes" for either the predicate device comparison or the DBM clinical healing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically relevant for human review of independent reads/interpretations, which is not described for this device's performance testing.
Clinical outcomes and radiographic assessments would involve medical review, but no specific adjudication method is mentioned.

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

No. This is not an AI/ML device, and no MRMC study, or any study involving human reader improvement with AI assistance, was conducted or described.

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

No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's inherent biological and physical properties. The osteoinductivity and viral inactivation tests could be considered "standalone" in that they assess the product itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Osteoinductivity:
- In-vitro: Bioassay measurements (proliferation of Saos human osteosarcoma cells, osteoinductivity index).
- In-vivo (animal model): Histological analysis (presence of new bone, cartilage, and/or chondrocytes in explants – explicitly defined).
- Clinical (DBM): Radiographic evaluation of healing.
Viral Inactivation: Assays demonstrating reduction of viral titers after processing.
Clinical Performance (comparison to predicate): Radiographic outcomes and adverse event profiles.
Canine model: Radiographic and histological methods.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an algorithm, this question doesn't apply.

Summary

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MAR - 5 2004

K020895

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ALLOMATRIX® Putty.

Submitted By:	Wright Medical Technology, Inc.
Date:	February 16, 2004
Contact Person:	Roger D. BrownSr. Director, Clinical and Regulatory Affairs
Proprietary Name:	ALLOMATRIX® Putty
Common Name:	Bone Void Filler
Classification Name and Reference:	Filler, Calcium Sulfate Preformed Pellets - Class II888.3045
Device Product Code and Panel Code:	Orthopedics/MQV

DEVICE INFORMATION

A. INTENDED USE

DEVICE DESCRIPTION B.

ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.

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SUBSTANTIAL EQUIVALENCE INFORMATION ﻧ

ALLOMATRIX® Putty was found to be substantially equivalent to the predicate device. The safety and effectiveness of ALLOMATRIX® Putty is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

Osteoinductivity Potential

The DBM incorporated into ALLOMATRIX® Putty is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle2, which demonstrated a correlation coefficient of 0.850 (p<0.0005) and accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. Additionally, clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3

ALLOMATRIX® Putty was assayed in vivo in the rat muscle pouch model2 and found to be osteoinductive. Each lot of ALLOMATRIX® Putty is assayed in vivo in the athymic rat muscle pouch to ensure the osteoinductivity potential of the final product.

Adkisson HD, Strauss-Schoenberger J, Gillis M, Wilkins R, Jackson M, and Hruska KA. Rapid Quantitative Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of 2 bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300. Note: The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes.
3 Wilkins RM. Clinical Iffectiveness of Demineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124

Viral Inactivation Validation

The method for processing the DBM contained in ALLOMATRIX® Putty 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 viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.

Product Performance Testing

Evaluation of clinical performance was evaluated by a comparison of radiographic outcomes and the adverse event profiles compared to the predicate device. There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device.

Performance of ALLOMATRIX® Putty was evaluated in a canine model by radiographic and histological methods.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines curving upwards, resembling an abstract representation of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K020895 Trade Name: ALLOMATRIX® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 6, 2004 Received: January 7, 2004

Dear Mr. Brown:

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.

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 cquivalence determination does not mcan 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

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Page 2 - Mr. Roger D. Brown

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice in and listing (21 CFR Part 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirents as sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ough managers of substantial equivalence of your device 510(K) prematice notification "Invice 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), If you desire specific ad ree for your as at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational and Consumer 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,

[signature]

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

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known):K020895______

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the ALLOMATRIX - Fatty is indicated only 10 000 000 is intended to be gently packed into bony stablify of the bolly stractal system (i.e., the extremities and pelvis). These defects may be volus of gaps of the skeletar of each (trom traumatic injury traumatic injury to the bone.

Prescription Use _ X (Per21 CFR 801.109)

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Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K020895

Division of General, Restorative, and Neurological Devices

510(k) Number K020855

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.