ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in 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® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), 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 text describes a medical device, ALLOMATRIX® Custom Putty, and its substantial equivalence to predicate devices, but not a study that establishes acceptance criteria and proves the device meets those criteria in the way typically associated with AI/software devices (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, the document focuses on:

Substantial Equivalence: The primary assertion is that ALLOMATRIX® Custom Putty is substantially equivalent to predicate devices.
Osteoinductivity Potential: This is assessed via in vitro bioassays or immunoassays for the Demineralized Bone Matrix (DBM) component, correlating results to athymic rat models and clinical results of DBM alone.
Viral Inactivation Validation: The processing method for DBM and CBM is evaluated for its ability to inactivate viruses.
Product Performance Testing (Clinical): Clinical performance involved a comparison of radiographic outcomes, subjective questionnaires (SF-36, Oswestry, VAS), and adverse events between the subject device (mixed with BMA and local bone) and autograft iliac crest bone for lumbosacral fusion. This study "demonstrated equivalency."

Therefore, I cannot populate the table and answer all the questions directly, as the nature of the evaluation presented is for a physical medical device (bone void filler) and not a software/AI device. There are no "acceptance criteria" in terms of performance metrics like sensitivity/specificity, nor an "AI algorithm" involved.

However, I can extract the relevant information regarding the clinical performance study for the physical device based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit for equivalence)	Reported Device Performance (Equivalency)
Clinical Equivalence to Autograft Iliac Crest Bone:	"This study demonstrated equivalency between the subject device and predicate autologous iliac crest bone where lumbosacral fusion is indicated."
* Radiographic Outcomes (Lenke fusion score)	* Not explicitly stated beyond "demonstrated equivalency."
* SF-36 subjective questionnaire	* Not explicitly stated beyond "demonstrated equivalency."
* Oswestry disability questionnaire	* Not explicitly stated beyond "demonstrated equivalency."
* Visual Analog Scale (VAS) for back and leg pain	* Not explicitly stated beyond "demonstrated equivalency."
* Adverse event profile	* Not explicitly stated beyond "demonstrated equivalency."
Osteoinductivity Potential (DBM component):	Each lot of DBM is evaluated in vitro using a cell-based assay (Saos human osteosarcoma cell proliferation) or immunoassay for a native protein, correlated to athymic rat model and clinical results of DBM alone.
Viral Inactivation:	The processing method demonstrated "suitable viral inactivation potential" for a wide spectrum of potential human viruses. (No specific log reduction or success rate is provided).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for the clinical performance study. "[A] comparison of radiographic outcomes... compared to autograft iliac crest bone" implies a clinical trial with a patient cohort, but the text does not give the number of patients.
Data Provenance: The document does not specify the country of origin. The study is a "clinical performance" evaluation, suggesting it is prospective (a clinical trial), but it is not explicitly called out as such.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept (experts establishing ground truth for a test set) is not applicable to this physical device evaluation. Radiographic outcomes would have been interpreted by clinicians as part of standard medical practice for the clinical trial endpoints.

4. Adjudication method for the test set:

Not applicable in the context of this device evaluation. Clinical trial endpoints would typically have pre-defined criteria for assessment.

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:

Not applicable. This is not an AI/software device. The clinical study compared the device to autograft, not human readers with or without AI assistance.

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

Not applicable. This is not an AI/algorithm.

7. The type of ground truth used:

For the clinical performance study, the "ground truth" would be clinical outcomes data (radiographic fusion scores, patient-reported outcomes like SF-36, Oswestry, VAS) and adverse event profiles, measured during the clinical evaluation in comparison to a predicate treatment (autograft iliac crest bone).
For osteoinductivity, the "ground truth" for correlation was results from athymic rat models and clinical results of DBM alone as referenced in the provided studies.
For viral inactivation, the "ground truth" involved demonstrating inactivation of model potential human viruses.

8. The sample size for the training set:

Not applicable. This is not a machine learning/AI device requiring a training set.

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

Not applicable.

Summary

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MAR 6 2006

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® Custom Putty.

Submitted By:	Wright Medical Technology, Inc.
Date:	November 18, 2005
Contact Person:	Brian J. YoungSr. Director, Regulatory Affairs
Proprietary Name:	ALLOMATRIX® Custom Putty
Common Name:	Bone Void Filler
Classification Name and Reference:	Filler, Calcium Sulfate Preformed Pellets – Class II-888.3045
Device Product Code and Panel Code:	Orthopedics/MOV

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

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ﻧ SUBSTANTIAL EQUIVALENCE INFORMATION

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

Osteoinductivity Potential

F.ach lot of Demineralized Bone Matrix (DBM) incorporated into ALLOMATRIX® Custom is evaluated in vitro using a surrogate cell-based assay . 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 this bioassay were correlated to the athymic rat models and to clinical results of assayed DBM alone'.

Each lot of DBM incorporated into ALLOMATRIX® Custom is assayed in vitro for a native protein as a surrogate test marker for osteoinductive potential . Results from this immunoassay were correlated to the athymic rat model for the DBM alone and the ALLOMATRIX® Putty3. Although only one native protein is used as the test marker, it is the combination of various proteins that is responsible for its osteoinductive potential.

Testing each lot of DBM with this cell-based bioassay' or immunoassay' assures that only DBM with osteoinductive potential is used in the ALLOMATRIX® Custom. The combination of DBM, Cancellous Bone Matrix (CBM), and binding medium has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay or immunoassay', will correlate with human clinical performance of ALLOMATRIX® Custom.

1. Wilkins, R.M. (1999) Clinical Effectiveness of Demincratized Bono Matrix Assayed in Human Cell Culture Advances in Tissue Banking. 3:113-124.
  This study correlated the results from the bioassay to results in the athymic rat model and clinical results of the DBM.
1. Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of hone marrow and bone matrix. Clin Orthop 1980 Jul-Aug.(150):288-300.
1. Data on file at Wright Medical Technology, Inc.

Viral Inactivation Validation

The method for processing the DBM and CBM contained in ALLOMATRIX® Custom 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.

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Product Performance Testing

Clinical performance of the subject device mixed with BMA and local bone was evaluated by a comparison of radiographic outcomes (i.e., Lenke fusion score), SF-36 subjective questionnaire, Oswestry disability questionnaire, Visual Analog Scale for back and leg pain, and adverse event profile compared to autograft iliac crest bone. This study demonstrated equivalency between the subject device and predicate autologous iliac crest bone where lumbosacral fusion is indicated.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 6 2006

Wright Medical Technology, Inc. C/o Mr. Brian J. Young Senior Director, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K053319

Trade/Device Name: ALLOMATRIX® Custom Putty Regulation Number: 21 CFR 888.3045 Regulation Name resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV and MBP Dated: January 9, 2006 Received: January 10, 2006

Dear Mr. Young:

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 (see 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 - Mr. Brian J. Young

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. 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), please contact the Office of Compliance at (240) 276-0120. 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 Division of Small Manufacturers, International 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/industry/support/index.html.

Sincerely yours,

Heike Semmel up

for

Mark N. Melkerson, M.S. Acting 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): K053319

Device Name: ALLOMATRIX® Custom Bone Void Filler

Indications for Use:

ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Prescription Use × (Per21 CFR 801.109)

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)

Hells Lumm

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

510(k) Number K053319

Page 1 of 1

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.