OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone.

OpteCure may be used with rigid fixation systems.

Device Description

Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids.

Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for Optecure™ + CCC

The provided document is a Traditional 510(k) Summary for Optecure™ + CCC, primarily focusing on establishing substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria. As such, the information you've requested regarding specific acceptance criteria and a detailed study proving the device meets them is largely absent.

The document describes the device and its intended use, and briefly touches on safety and effectiveness information, but it does not detail a specific performance study with quantitative acceptance criteria, sample sizes, expert involvement, or adjudication methods for demonstrating clinical performance.

Here's what can be inferred and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative acceptance criteria for device performance. The submission focuses on substantial equivalence to predicate devices.	Osteoinductive Potential: Samples from each lot of donor demineralized bone matrix (DBM) are tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are noted as "not necessarily predictive of human clinical results."
Viral Inactivation Efficacy (Quantitative standard for viral reduction)	A viral reduction study demonstrated that "the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses" (representing RNA, DNA, envelope, and non-envelope viruses). The specific quantitative reduction (e.g., log reduction) is not provided.

Explanation:
The document's primary argument for safety and effectiveness lies in its substantial equivalence to already cleared predicate devices regarding design, material composition, and function. The "Safety & Effectiveness Information" section describes the tests performed to ensure the safety of the DBM component (osteoinductivity and viral inactivation) but does not present these as acceptance criteria for the entire device's clinical performance or a comparative study.

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

Test Set Sample Size: Not applicable/Not provided. The document does not describe a clinical "test set" for evaluating device performance against pre-defined acceptance criteria.
Data Provenance:
- Osteoinductive Potential: In-vivo athymic mouse assay (animal model data).
- Viral Inactivation Validation: Conducted by a CLIA certified testing laboratory (likely in vitro or ex vivo testing of the DBM component).

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

Not applicable/Not provided. No human expert review or "ground truth" establishment for a clinical test set is described.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No adjudication method for a clinical test set is described.

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

No. An MRMC comparative effectiveness study is not mentioned or described in the provided summary. This type of study is more common for diagnostic imaging AI systems, not typically for bone void fillers that primarily demonstrate bioactivity and safety.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not provided. This device is a bone void filler, not an algorithm or AI system.

7. The Type of Ground Truth Used

For Osteoinductive Potential: The "ground truth" is based on the biological response observed in the in-vivo athymic mouse assay (formation of new bone).
For Viral Inactivation: The "ground truth" is based on the measured reduction of specific model viruses in laboratory testing.
For overall device effectiveness for its indications: The "ground truth" (or basis of approval) for the device's intended use as a bone graft extender/filler is its substantial equivalence to predicate devices, which implies that their established safety and effectiveness apply.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable/Not provided. This device is not an AI/ML algorithm.

Summary of what the document does convey regarding "proving" the device:

The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting new, large-scale clinical trials with specific acceptance criteria, the manufacturer argues that Optecure™ + CCC is as safe and effective as other legally marketed devices because it shares similar design, material composition, and function, and undergoes standard safety testing for its components (like osteoinductivity and viral inactivation validation for the donor bone matrix). The FDA's 510(k) clearance (K061668) confirms this assessment of substantial equivalence.

Summary

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2320 NW 66TH COURT GAINESVILLE, FL 32653

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

House stransmission in the

SEP 1 2 2006

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

This 510(k) Summary for Optecure™ + CCC is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

Sponsor:	Exactech Inc.2320 NW 66th CourtGainesville, Florida 32653Telephone 352-377-1140Fax 352-378-2617
	FDA Establishment Number 1038671
Contact:	Maritza EliasRegulatory RepresentativeExactech Inc.2320 NW 66th CourtGainesville, FloridaTelephone 352-377-1140Fax 352-378-2617
Proprietary Name:	Optecure™ + CCC
Common Name:	Bone void filler,
Product Code:	MQV, MBP
Device Class:	Class II
Classification Name:	21CFR §888.3045 Resorbable calcium saltbone void filler device
Classification Panel:	Orthopedic

Rev 06 07 06

Section 4 Page 1 of 3

A Great Day in the O.R.

EXACIECH assist to inqrowe the quality of the notin'n their octin'y ond independent. We do this through including poducts, aduction and consimation to series

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2320 NW 66TH COURT GAINESVILLE, FL 32653

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

Legally Marketed Devices for Substantial Equivalence Comparison:

ProductCode	Manufacturer	510(k) Number	Product
MQV, MBP	Exactech Inc.	K050806	Optecure™
MQV	RegenerationTechnologies	K043421	Opteform®
MQV, MBP	Osteotech	K051195	Grafton® DBM
MQV, MBP	IsoTis	K050642	OrthoBlast® II
MQV, MBP	MuskuloskeletalTissueFoundation	K040262	DBX® Demineralized BoneMatrix Mix

Optecure™ + CCC is substantially equivalent to one or more of the 510(k) cleared predicate devices summarized in the above table in that they share similar design, material composition and function.

Device Description:

Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

Indications:

Optecure™ + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure™ + CCC may be used with rigid fixation systems.

Rev 06 07 06

Section 4 Page 2 of 3

A Great Day in the O.R.

EXACTECH exist to intraduals by maintining their a citivity and independere. We do this through increative iseas, high-quoting products, education and commitment to sence

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Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

Safety & Effectiveness Information

Ostcoinductive Potential a.

Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are not necessarily predictive of human clinical results.

b. Viral Inactivation Validation

A viral reduction study was conducted by a CLIA certified testing laboratory using four virus models representing RNA, DNA, envelope and non-envelope virus. This study demonstrates the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

Rev 06 07 06

Section 4 Page 3 of 3

A Great Day in the O.R."

EXACTECH exist to inprove the quality of it in independent. We to the more interest increative increative idess, high-quility podect, aduction and commitment senses.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2006

Exactech % Ms. Maritza Elias Regulatory Representative 2320 NW 66th Court Gainesville, FL 32653

Re: K061668

Trade/Device Name: Optecure™ +CCC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Codes: MBP, MQV Dated: June 7, 2006 Received: June 14, 2006

Dear Ms. Elias:

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 l'ederal 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 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);

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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 m 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), n you deente spee 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 may bound band gallery, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbaya Buckins

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

Enclosure

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Exactech, Inc.® Optecure™ + CCC Traditional 510(k)

Indications For Use

510(k) Number (if known):

Indications for Use:

OpteCure may be used with rigid fixation systems.

Prescription Use

Over the Counter Use VANJAO.

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

Rev 05/30/06

510(k) Number K061668

Section 3 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.