The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

Device Description

The proposed Exactech Optetrak® Proximal Tibial Spacer (PTS) is a titanium alloy spacer that assembles with the Optetrak® Tibial Tray and the Optetrak® Tibial Insert prostheses to replace the correct amount of joint space. This allows a combined tibial insert/tibial tray thickness comparable to the thickness provided by larger tibial inserts, while maintaining the function and performance of the predicate Optetrak Knee tibial insert/tibial tray assembly. The proposed Optetrak PTS is intended to take the place of inserts larger than 15mm by mating with the thinner inserts (ranging from 9mm to 15mm) to achieve the same total thickness.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Exactech Optetrak® Proximal Tibial Spacer, based on the provided 510(k) summary:

This device is a Class II medical device, and the submission is a 510(k) premarket notification. 510(k) submissions typically do not involve clinical trials with human readers or standalone algorithm performance studies in the way AI/ML devices do. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested categories (like MRMC studies, number of experts, training set size, etc.) are not applicable in this context.

The "study" that proves the device meets the acceptance criteria is primarily non-clinical performance data demonstrating substantial equivalence.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (Exactech Optetrak® Proximal Tibial Spacer)
Intended Use: For total knee joint replacement, identical indications for use as predicate devices.	The Exactech Optetrak® PTS is intended for use in total knee joint replacement and has identical indications for use as the predicate devices.
Materials: Composed of equivalent materials conforming to recognized industry standards for permanent implants.	The Exactech Optetrak® PTS is composed of equivalent materials conforming to recognized industry standards for permanent implants.
Dimensions: Available in equivalent size ranges and has matching mating geometries to predicate devices.	The Exactech Optetrak® PTS components are available in equivalent size ranges and have matching mating geometries to the predicate devices.
Sterilization processes: Sterilized using equivalent sterilization processes conforming to recognized industry standards.	The Exactech Optetrak® PTS is sterilized using equivalent sterilization processes conforming to recognized industry standards.
Performance specifications: Conforms to recognized performance standards for total knee replacement devices, with equivalent performance to predicates.	The Exactech Optetrak® PTS conforms to recognized performance standards for total knee replacement devices, and its performance specifications are equivalent to the predicates.

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

Sample Size for Test Set: Not applicable in the context of clinical images or patient data. The "test set" here refers to the specific components of the device that underwent mechanical testing. The document does not specify the exact number of spacers tested, but rather refers to "mechanical tests and engineering analyses."
Data Provenance: Not applicable. The data is from in-vitro mechanical testing and engineering analyses, not human patient data or images.

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)

Number of Experts: Not applicable. Ground truth for mechanical performance is established through recognized engineering standards and test methodologies, not expert interpretation of clinical data. This would be determined by qualified engineers and material scientists.
Qualifications of Experts: Not specified, but implied to be qualified engineers/scientists conducting and interpreting the mechanical tests.

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

Adjudication Method: Not applicable. This concept applies to human interpretations of clinical data, not mechanical testing.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for a prosthetic device demonstrating substantial equivalence via mechanical testing. This device is not an AI/ML imaging device where "human readers" would be involved in interpreting outputs.

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

Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The performance demonstrated is the standalone mechanical integrity of the device itself.

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

Type of Ground Truth: The ground truth for this device's performance is based on recognized industry standards and engineering principles for permanent implants. This includes material property specifications, dimensional tolerances, biomechanical load testing parameters, and adherence to established sterilization protocols. The "predicate devices" serve as the benchmark for this ground truth performance.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set" of data.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a physical implant.

Summary

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K071738

AUG 15 2007

3.2 377 - 40 FAX 3520178 2617

510(k) Summary

Company:	Exactech, Inc
EstablishmentRegistration:	1038671
Date:	June 25, 2007
Contact Person:	Amnon Talmor, Regulatory Affairs Specialist
Proprietary Name:	Exactech Optetrak® Proximal Tibial Spacer
Common Name:	Tibial Knee Implant
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi constrainedcemented prosthesis (21 CFR 888.3560, Class II, Product Code JWH)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

Device Name	510(k)/ProductCode
Exactech Cruciate Retaining Cemented Tibial Components	#K932776/JWH
Exactech Optetrak® Total Knee System Tibial Component	#K933610/JWH
Exactech Porous Coated Finned Tibial Tray Component	#K936079/JWH
Exactech Optetrak® Constrained Condylar Knee for Cemented Use	#K954208/JWH
Exactech Optetrak® Size 0 and 1 Delta Line Extension	#K011976/JWH
Exactech Optetrak® Total Knee System Offset Tibial Tray	#K023186/JWH
Optetrak® Total Knee System HI-FLEX Posterior-Stabilized Tibial InsertComponents	#K033883/JWH

Device Description

Indications for Use

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Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics.

Intended Use. Exactech Optetrak® PTS and predicate devices are intended for use in total . knee joint replacement and have identical indications for use.
Materials. Exactech Optetrak® PTS and predicate devices are composed of equivalent . materials conforming to recognized industry standards for permanent implants.
Dimensions. Exactech Optetrak® PTS and predicate device components are available in . equivalent size ranges and have matching mating geometries
Sterilization processes. Exactech Optetrak® PTS and predicate devices are sterilized using . equivalent sterilization processes conforming to recognized industry standards.
Performance specifications. Exactech Optetrak® PTS and predicate devices conform to . recognized performance standards for total knee replacement devices. The performance specifications for the Exactech Optetrak® PTS are equivalent to the predicates.

Summary of Non-Clinical Performance Data

Mechanical tests and engineering analyses were conducted to demonstrate the safety and effectiveness of the Exactech Optetrak® PTS and support the claim of substantial equivalence to the predicates listed above.

Substantial Equivalence Conclusion

Results from mechanical tests and engineering analyses provided within this 510(k) demonstrate that the Exactech Optetrak® PTS are substantially equivalent to the identified predicate devices. That is, the proposed device is as safe and effective and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three overlapping wing segments, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc. % Mr. Amnon Talmor Regulatory Affairs Specialist 2320 N. W. 66th Ct. Gainesville, FL 32608

AUG 1 5 2007

Re: K071738

Trade/Device Name: Exactech Optetrak® Proximal Tibial Spacer Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: June 25, 2007 Received: June 26, 2007

Dear Mr. Talmor:

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 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.

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Page 2 – Mr. Amnon Talmor

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your and equivalence of your device to a legally premarket notheadon: "The PDA mianing of basification 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 Joan at (240) 276-0120. Also, please note the regulation entitled, Comact the Office of Complians an (21 t m =1 cart 807.97). You may obtain Milsonanding by reference to premantonitibilities under the Act from the Division of Small other general international and Consumer Assistance at toll-free number (800) 638-2041 or Manufacturers, International and Oosts http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Barbave Buelup

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

Enclosure

HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ- 410 DGRND

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Exactech®, Inc.

Indications for Use

K071738

510(k) Number (if known):

Device Name: Exactech Optetrak Proximal Tibial Spacer

INDICATIONS FOR USE:

Prescription Use and/or × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chubare Onelus

Division of General, Restorative, and Neurological Devices

510(k) Number K071736

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.