OpteCure 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 may be used with rigid fixation systems.

Device Description

OpteCure comes in the form of a kit with pre-measured powder and demineralized bone matrix (DBM), pre-measured 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. Supplied as aseptic manufacture, single use, ready to mix implantable device derived from a single donor.

OpteCure gradually resorbs and is replaced with new bone during the healing process.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called OpteCure, which is a bone void filler. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy of a novel device through a detailed study with acceptance criteria in the way an AI/ML device might be evaluated.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and human-AI comparative effectiveness studies is not applicable to this document. The 510(k) summary focuses on demonstrating that OpteCure is substantially equivalent to existing legally marketed devices, primarily through comparison of its design, materials, and intended use, and by showing safety data (like viral inactivation and osteoinductive potential) and performance data (like resorption).

Here's an explanation based on the provided text, outlining why the requested AI/ML-specific details are not present:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria in the context of a performance study as would be seen for an AI/ML device. Instead, it states that "OpteCure is the substantially equivalent to the predicate devices." The device's "performance" is implicitly demonstrated through its similarity to predicate devices and results from tests such as osteoinductive potential and viral inactivation.
- Osteoinductive Potential: "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." The findings are not necessarily predictive of human clinical results. This is a biological characteristic test, not a performance metric against clinical acceptance criteria.
- Viral Inactivation Validation: "A viral reduction study was conducted... This study demonstrates the demineralization process... significantly diminishes these model viruses..." This is a safety validation, not a performance metric for the device's main function as a bone void filler in humans.
Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The document mentions an "in-vivo athymic mouse assay" for osteoinductive potential and a "viral reduction study," but does not specify sample sizes for these, nor provenance of test data in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, test set, or expert evaluation in the AI/ML context mentioned in the document.
Adjudication method: Not applicable. No adjudication method is mentioned for any clinical or performance study.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This document does not concern an AI system or human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for this device's efficacy is its substantial equivalence to predicate devices and results from non-clinical tests (like osteoinductivity and viral inactivation) which evaluate biological properties and safety, respectively.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional 510(k) submission for a physical medical device (bone void filler), where the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. It does not involve AI/ML technology, and therefore, the requested information pertaining to AI/ML device evaluation criteria, study design, and performance metrics is irrelevant to this specific submission.

Summary

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050806

FEB 8 2006

Traditional 510(k) Summary of Safety and Effectiveness

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

1.	Submitter:	Exactech Inc.2320 NW 66th CourtGainesville, Florida 32653Telephone 352-377-1140Fax 352-378-2617
	Contact person:	Maritza EliasRegulatory RepresentativeExactech Inc.2320 NW 66th CourtGainesville, FloridaTelephone 352-377-1140Fax 352-378-2617
	Date of original 510k submission:	March 27, 2005
	Date of follow-up information	November 7, 2005
	FDA Establishment Number	1038671
2.	Proprietary Name:	OpteCure
	Common Name:	Bone void filler
	Product Code:	MQV, MBP
	Device Class:	Class II
	Classification Name:	21CFR §888.3045 Resorbable calciumsalt bone void filler device
	Classification Panel:	Orthopaedic

Page 1 of 3

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Traditional 510(k) Summary of Safety and Effectiveness

Legally Marketed Devices for Substantial Equivalence Comparison: 3.

Product Code	Manufacturer	510(k)Number	Product
MQV, MBP	Exactech Inc.	K040755	Exactech Resorbable BonePaste
MQV	RegenerationTechnologies Inc	K043420	Regenafil Allograft Paste,Regenafil RT Paste, OsteofilOptefil, RTI Allograft Paste
MQV	Biomatlante	K043005	MBCP
MQV	Wright MedicalTechnologies	K020895	Allomatrix

Comparison to the Predicate Device(s): 4.

OpteCure is the substantially equivalent to the predicate devices.

ડ. Device Description:

OpteCure gradually resorbs and is replaced with new bone during the healing process.

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Traditional 510(k) Summary of Safety and Effectiveness

Indications for Use 6.

OpteCure may be used with rigid fixation systems.

7. Safety & Effectiveness Information

Osteoinductive Potential થ.

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 Opte Cure significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 8

Ms. Maritza Elias Regulatory Affairs Representative Exactech Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K050806

OpteCure Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: November 8, 2005 Received: November 10, 2005

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 the Federal F 60d, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 (1 var 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 Eederal 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.

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Page 2 -- Ms. Maritza Elias

You must comply with all the Act's requirements, including, but not limited to: registration 1 od inton compry with and 1979; 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); 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 maj count 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/cdrl/industry/support/index.html.

Sincerely yours,

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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Indications for Use

510(k) Number (if known):

K050806

OpteCure Device Name:

Indications for Use:

OpteCure may be used with rigid fixation systems.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K050806
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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.