The OPTETRAK® Total 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. CAUTION: For cemented use only in the USA.

Device Description

Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472). The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon. The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208).

AI/ML Overview

The provided document describes a Special 510(k) submission for additional sizes of the Exactech Optetrak Total Knee System Stem Extensions. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device, often by showing that the new device shares the same fundamental technology, materials, and intended use, and that any minor differences do not raise new questions of safety or effectiveness.

Crucially, this submission does not contain a clinical study or performance data that would typically be described with acceptance criteria, sample sizes, expert ground truth, or adjudication methods as commonly found in AI/ML device evaluations.

Instead, the submission states:

"The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified. According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions." (Section 3)

This means the "study" proving the device meets acceptance criteria is based on analytical analysis and a comparison to predicate devices, rather than a clinical trial or algorithm performance study.

Given this context, I will address your specific points based on the available information:

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

Since this is a submission for additional sizes of an existing PREDICATE device, the "acceptance criteria" are not reported as specific performance metrics in a clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance (as stated in the 510(k))
Design comparability to predicate device (e.g., materials, Morse taper, flute design)	"The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon." (Section 2)
Material composition equivalent to predicate device	"Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472)." (Section 2)
Functional equivalence: expected similar strength and clinical outcomes to predicate device.	"According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions." (Section 3)
Compatibility with existing components	"The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208)." (Section 2)
No new failure modes identified compared to predicate device	"The design assurance reviews for the proposed products did not indicate the need for additional testing since... no new failure modes were identified." (Section 3)
Sterilization effectiveness (implicit)	Method: Gamma radiation (Cobalt 60 source); Dose: 25 - 37 kGy; Sterility Assurance Level (SAL): 10^-6 (Section 2) - This confirms the sterilization method, but its effectiveness is assumed to be comparable to predicate devices using similar methods.

Regarding the remaining points, they do not apply to this type of 510(k) submission, as it is not an AI/ML device or a device requiring a clinical performance study with human readers or structured ground truth annotation.

Here's why:

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

Not applicable. No test set or clinical data was used in the manner of an AI/ML or clinical performance study. The evaluation was based on analytical comparison to a predicate device.

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. No expert review of a test set was conducted for ground truth establishment.

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

Not applicable. No test set requiring adjudication was used.

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 a medical implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical implant, not an algorithm.

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

Not applicable. Ground truth in the context of clinical data or AI performance is not relevant here. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (the original Optetrak stem extensions).

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" in the AI/ML sense.

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

Not applicable. As above, no training set or associated ground truth.

Summary

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KO12251

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

JUL 3 1 2001

Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

510(k) Summary of Safety and Effectiveness Special 510(k)

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

Phone:	(352) - 377 - 1140
Fax:	(352) - 378 - 2617

FDA Establishment Number 1038671

Robert Paxson Contact: Director of Engineering & Development

Date:

June 22, 2001

Section 4 Page 1 of 4

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Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

510(k) Summary of Safety and Effectiveness Special 510(k)

Classifications / Proprietary Names:

Classification Name:

Prosthesis, knee, patellofemorotibial, semi-contrained, cemented, polymer/metal polymer

Trade / Proprietary Model Names:

Optetrak Total Knee System Stem Extensions - Additional Sizes

JWH Product Code: 888.3560 C.F.R. Section:

II Device Class:

Classification Panel: Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer	510(k) Number
Optetrak Total KneeOptetrak Total Knee	ExactechExactech	#K933610#K954208
Nexgen	Zimmer	--------
Maxim	Biomet	--------
Durcon Total Stabilizer	Howmedica	--------

Device Information:

INDICATIONS

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

CAUTION: For cemented use only in the USA.

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Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

510(k) Summary of Safety and Effectiveness Special 510(k)

CONTRAINDICATIONS

The OPTETRAK® Total 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, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

DEVICE DESCRIPTION

Packaging Materials
Material	Composition
Vacuum Bag	High Barrier – 3 Mil, 75 gaugeNylon with EVOH 2.25 Polyethylene
Polymer Bags	3 Mil Polyethylene
Inner/Outer Pouches	48GAPET/.002LDPE
Pouch Seals	1073B Uncoated Tyvek®
Box	Heavy weight cardboard
Outer Shrink-Wrap	Clear, Light-Weight Plastic
Shipping Cartons	Heavy-weight Corrugated Cardboard

PACKAGING MATERIALS

STERILIZATION INFORMATION

Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 10-6

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Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes

510(k) Summary of Safety and Effectiveness Special 510(k)

PERFORMANCE DATA

The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified.

According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions.

We conclude that the new Optetrak Stem Extensions are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.

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Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

JUL 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Paxson Director of Engineering & Development Exactech. Inc. 2320 N.W. 66th Court Gainsville, Florida 32653

Re: K012251

Trade Name: Optetrak Total Knee System Regulatory Class: II Regulation Number: 888.3560 Product Code: JWH Dated: July 17, 2001 Received: July 18, 2001

Dear Dr. Paxson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. Robert Paxson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific darices), please contact the Office of Compliance at additionally 609110 for questions on the promotion and advertising of your device, (2017) 59 + 105 + 1 = 0 ffice of Compliance at (301) 594-4639. Also, please note the regulation predise ounder the Oriety of eference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

R.M.M.h.l.u.u.m.o. P.R.

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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Exactech® Optetrak Total Knee System Straight Stem Extensions - Additional Sizes

Indications for Use

510(k) Number:

K. 2-25|

Device Name:

Optetrak Total Knee System Straight Stem Extensions

INDICATIONS

CAUTION: For cemented use only in the USA.

CONTRAINDICATIONS

smhheeein2

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

510(k) Number K012251

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use

Section 3 Page 1 of 1

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.