Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes ) throughout the implantation period.

Device Description

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The two-component unconstrained design incorporates a femur and tibial component, it's fully formed by gentamicin/polymethyImethacrylate (PMMA) bone cement.

AI/ML Overview

This 510(k) summary for the Spacer-K knee prosthesis modification does not include the detailed information required to describe acceptance criteria and a study proving device performance in the way you've outlined. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.

However, I can extract information related to the device's characteristics and the basis for its clearance:

Here's what can be gathered, and what is explicitly missing from the provided text:

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

Missing from the document. The 510(k) summary states that the modified Spacer-K has "equivalent performance and mechanical characteristics" to the predicate Spacer-K (K032522) and a "similar gentamicin release profile" to another predicate (K050210). However, it does not provide specific acceptance criteria (e.g., minimum tensile strength, specific drug release rates) or reported numerical performance data from a study.

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

Missing from the document. There is no description of a specific test set or clinical study with patient data. The equivalence is based on design, materials, and mechanical characteristics (likely bench testing or literature review, but details are not provided).

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)

Missing from the document. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of this 510(k) application.

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

Missing from the document. Not applicable given the type of submission.

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

Missing from the document. Not applicable. The Spacer-K is a physical medical device (a temporary knee prosthesis), not an AI-assisted diagnostic tool.

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

Missing from the document. Not applicable.

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

Missing from the document. For a device like this, "ground truth" would typically refer to established engineering standards for materials and mechanical properties, or validated methods for drug release testing. The document refers to "equivalent performance and mechanical characteristics" and "similar gentamicin release profile," implying that these aspects were compared to predicate devices, but the specific methodologies for determining this "truth" are not detailed.

8. The sample size for the training set

Missing from the document. Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Missing from the document. Not applicable.

Summary of what the document DOES provide regarding clearance:

The device (Spacer-K Modification) received 510(k) clearance (K062274) based on a demonstration of substantial equivalence to legally marketed predicate devices.

Predicate Devices:
- Spacer-K device (K032522): The modified Spacer-K has the "same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging" as this predicate.
- Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210): The modified Spacer-K has a "similar gentamicin release profile" when used with Biomet Cobalt G HV Bone Cement (K051532).

Key Takeaway: This 510(k) summary is typical for a device modification, where the primary goal is to show that the new version is as safe and effective as a previously cleared device. It does not contain the kind of detailed performance study and acceptance criteria you would expect from a de novo submission or a product requiring extensive clinical trials. The "study" here is essentially the comparison against the predicate devices across defined parameters (design, materials, mechanical characteristics, drug release).

Summary

{0}------------------------------------------------

Kobi74

Spacer-K Modification

MAY 22 2008

510 (k) Summary

· 510(k) Summary

Applicant/consultant:

EXACTECH® INC. 2320 N.W. 66TH COURT GAINESVILLE, FLORIDA 32653 PHONE: (352) - 377 - 1140 FAX: (352) - 378 - 2617 CONTACT: Mike Simpson

Manufacturer/Submitter:

TECRES S.P.A. VIA ANDREA DORIA 37066 SOMMACAMPAGNA VERONA — ITALY

TEMPORARY KNEE PROSTHESIS

FDA owner/operator ID #: 9033624

TEMPORARY KNEE SPACER WITH GENTAMICIN

PROSTHESIS, KNEE, PATELLOFEMORAOTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Date:

May 21, 2008

SPACER-K

888.3560

ORTHOPAEDIC

ואח

Trade/Proprietary model names:

Common name:

Device class:

Device classification name:

Regulation number:

Classification panel:

Classification Product Code:

p 1/2

{1}------------------------------------------------

Spacer-K Modification 510(k) Summary Continued

DEVICE DESCRIPTION

INDICATIONS FOR USE

Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic proccss. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes ) throughout the implantation period.

SUBSTANTIAL EQUIVALENCE:

The modified Spacer-K device has the same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging as the predicate Spacer-K device (K032522). Additionally, the modified Spacer-K device has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210) when used with predicate Biomet Cobalt G HV Bone Cement (K051532).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. 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

MAY 2 2 2008

Exactech, Inc. % Mr. Xavier Sarabia Director, Regulatory Affairs 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K062274

Trade/Device Name: Spacer K Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH

Dated: February 22, 2008 Received: February 25, 2008

Dear Mr. Sarabia:

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.

{3}------------------------------------------------

Page 2 – Mr. Xavier Sarabia

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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

Enclosure

{4}------------------------------------------------

Spacer-K Modification

Indications for Use

510(k) Number (if known): _ K062274

Device Name: Spacer-K

Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in Indications for Use: total knee replacement (TKR) in skeletally mature patients undergoing a twostage procedure due to a septic process.

Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ⊥ of ⊥

Nilre Ogl-fr mkn

p 1/1

Division of General, Restorative, and Neurological Devices

510(k) Number K062274

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.