Active sepsis which requires a two-stage revision arthroplasty procedure
Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period
Implantation period of 180 days or less
Use only with polymethylmethacrylate/gentamicin bone cement.
The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Device Description

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

AI/ML Overview

The provided text describes a medical device, the KASM® Knee Articulating Spacer Molds, and its performance evaluation for regulatory approval. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" as quantitative thresholds. Instead, it demonstrates substantial equivalence to a predicate device (StageOne™ Knee Cement Spacer Molds) through various non-clinical tests. The "acceptance criterion" in this context is achieving "substantial equivalence" for each tested property.

Property	Acceptance Criterion (Implicit)	Reported Device Performance
Gentamicin Elution Rate Study	Substantially equivalent to cement manufacturer's reported elution rate	Substantially equivalent antibiotic elution rate as compared to cement manufacturer's reported elution rate
Tibial Mechanical Strength	Substantially equivalent to StageOne™ tibial cement spacer	Substantially equivalent to StageOne™ tibial cement spacer (test adapted from ASTM F1800)
Tibial Fatigue Strength	Substantially equivalent to StageOne™ tibial cement spacer	Substantially equivalent to StageOne™ tibial cement spacer (test adapted from ASTM F1800)
Cement Spacer Wear Study	Substantially equivalent to StageOne™	Substantially equivalent to StageOne™ (test adapted from ISO 14243)

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

The document primarily describes non-clinical testing (bench testing) rather than studies involving human subjects or medical imaging data. Therefore, the concepts of "test set sample size" and "data provenance" in the usual clinical study sense are not directly applicable.

Sample Size for Testing: The specific number of molds or cement spacers tested for each property (e.g., how many were used for the elution rate study or wear study) is not provided in the document.
Data Provenance: The data originates from the manufacturer's (Ortho Development Corporation) non-clinical testing. No country of origin for data is specified, as these are lab tests. The testing itself would have been conducted by or for the manufacturer. It is inherently retrospective in the sense that it evaluates the manufactured device prototypes.

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)

This question is not applicable to the provided document. The evaluation of KASM® Knee Articulating Spacer Molds is based on non-clinical, mechanical, and material performance studies compared to a predicate device, not on expert interpretation of clinical data or images. Ground truth is established by objective measurements in laboratory settings, not by expert consensus.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data (e.g., medical images) and their decisions need to be reconciled. As stated above, this submission focuses on non-clinical performance data.

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

This question is not applicable. An MRMC study is a clinical study design used to compare diagnostic accuracy of different methods (e.g., with and without AI assistance) based on multiple readers interpreting multiple cases. The provided document concerns a physical medical device (spacer molds) and its non-clinical performance, not an AI-based diagnostic tool or clinical effectiveness study involving human readers.

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

This question is not applicable. The device is a physical medical device (molds), not an algorithm or software. It does not have "standalone" performance in the context of an algorithm. Its performance is evaluated through material properties and mechanical function.

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

The "ground truth" for the non-clinical tests was established through objective laboratory measurements and tests designed to assess material properties (e.g., elution rate) and mechanical performance (e.g., strength, fatigue, wear). The comparison was made against either the cement manufacturer's reported elution rates or the performance of the predicate device (StageOne™).

8. The sample size for the training set

This question is not applicable. This document describes the evaluation of a physical medical device. There is no concept of a "training set" as would be used for machine learning models or algorithms.

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

This question is not applicable for the same reasons as in point 8.

Summary

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FEB 1882014

Section 5

510(k) Summary

NAME OF SPONSOR:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) CONTACT:	Mike EnsignDirector of Regulatory Affairs and Quality AssuranceTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: mensign@odev.com
DATE PREPARED:	October 30, 2013
PROPRIETARY NAME:	KASM® Knee Articulating Spacer Molds
COMMON NAME:	Total Knee Replacement Prosthesis
CLASSIFICATION:	21 CFR 888.3560, Knee joint, patellofemorotibial,polymer/metal/polymer semi-constrained cemented prosthesis
DEVICE PRODUCT CODES:	JWH, MBB
PREDICATE DEVICES:	StageOne™ Knee Cement Spacer Molds, Biomet (K050210)

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Device Description

Indications for Use

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

1. Active sepsis which requires a two-stage revision arthroplasty procedure
1. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period
1. Implantation period of 180 days or less

Use only with polymethylmethacrylate/gentamicin bone cement.

The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Technological Characteristics

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There are two differences between the KASM® cement spacer molds and its predicate, the StageOne™ Knee Cement Spacer Molds. First, KASM® molds are fabricated using Pellethane, a medical-grade thermoplastic urethane; StageOne™ Knee Cement Spacer Molds are fabricated from a medical-grade silicone elastomer. Second, the KASM® femoral mold is designed as an open-faced mold to be filled and placed in situ allowing the cement spacer to cure in place in a single step; the StageOne™ femoral mold is designed as a fully enclosed mold that must be filled utilizing a pressurized cement injector system. Once cured, the StageOne™ femoral cement spacer mold is torn open and the released femoral cement spacer is affixed to patient anatomy using a second bone cement curing step.

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The KASM® and StageOne™ tibial spacer molds are used in an identical fashion; both molds are openfaced and intended to be filled to the desired thickness, allowed to cure, then affixed to patient anatomy using a second bone cement curing step.

Performance Data

The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:

Property	Result
Gentamicin Elution Rate Study	Substantially equivalent antibiotic elution rate as compared to cement manufacturer's reported elution rate
Tibial Mechanical Strength	Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Tibial Fatigue Strength	Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Cement Spacer Wear Study	Substantially equivalent to StageOne™
*test adapted from ISO 14243

Basis for Substantial Equivalence

This 510(k) demonstrates that the KASM® femoral and tibial cement spacer molds are substantially equivalent to the previously cleared predicate device based on similarities in intended use, design, materials, and mechanical performance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2014

Ortho Development Corporation Mr. Mike Ensign Director of Regulatory Affairs and Quality Assurance 12187 South Business Park Drive Draper, Utah 84020

Re: K133449

Trade/Device Name: KASM® Knee Articulating Spacer Molds Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II Product Code: JWH, MBB Dated: January 3, 2014 Received: January 7, 2014

Dear Mr. Ensign:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Mike Ensign

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Lori A. Wigqins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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'DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133449

Device Name

KASM® Knee Articulating Spacer Molds

Indications for Use (Describe)

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

Active sepsis which requires a two-stage revision arthroplasty procedure
Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, clos, for the entire implantation period
Implantation period of 180 days or less

Use only with polymethylmethacrylate/gentamicin bone cement.

The articulating cement spacer prosthesis fashioned using the KASM® mold is intended fixation only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Laurence D. Coyne -S

(Division Sign-Off)

Division of Orthopedic Devices

510(k) Number: K133449

FORM FDA 3881 (9/13)

Page of

2C Publishing Services (101) 443-6740

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.