· Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
· Patients with failed previous surgery where pain, deformity, or dysfunction persists
· Correctable varus-valgus deformity and moderate flexion contracture
· Revision of a previously failed knee arthroplasty
· Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Device Description

The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Knee Joint Prosthesis (Klassic® Knee System). It details the device's indications for use, its classification, and a comparison to predicate devices, particularly focusing on a new line extension, the Klassic® Femur with Aurum®.

This document does not contain any information regarding AI/ML device performance testing, clinical studies with human readers, or ground truth establishment relevant to AI/ML systems. The "acceptance criteria" discussed are likely related to the mechanical and biocompatibility performance of the knee implant, not an AI/ML algorithm's diagnostic accuracy.

Therefore, I cannot provide an answer based on the prompt's request for AI/ML device performance without the presence of such information in the provided text.

The closest relevant sections in the provided text are:

Non-Clinical Bench Testing and Engineering analyses: These were performed to evaluate the physical properties of the Klassic® Femur with Aurum® (e.g., strength of coating, fatigue, wear, stability, contact stress, range of motion, patella-femoral resistance). This refers to the mechanical integrity and function of the physical implant, not an AI algorithm.
LAL testing requirements for orthopedic implants: This refers to Limulus Amebocyte Lysate testing for bacterial endotoxins, a biocompatibility test, not an AI algorithm's performance.

To answer your request, the input text would need to describe a study evaluating an AI/ML algorithm's performance, including details such as:

Acceptance criteria for algorithm metrics (e.g., sensitivity, specificity, AUC).
Test set characteristics (sample size, data provenance, image types).
Ground truth establishment (number and qualifications of experts, adjudication methods).
Human reader studies (MRMC design, effect sizes of AI assistance).
Standalone algorithm performance.
Training set details (sample size, ground truth methodology).

Summary

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July 23, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Total Joint Orthopedics, Inc. % Holly Rhodes VP, Orthopedic Regulatory Affairs Mcra, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K211602

Trade/Device Name: Klassic® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OIY Dated: May 24, 2021 Received: May 24, 2021

Dear Holly Rhodes:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211602

Device Name Klassic Knee System

Indications for Use (Describe)

The Klassic® Knee System is intended for prosthetic replacement of the following:
· Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
· Patients with failed previous surgery where pain, deformity, or dysfunction persists
· Correctable varus-valgus deformity and moderate flexion contracture
· Revision of a previously failed knee arthroplasty
· Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117
Contact:	Mr. Chris WeaberDirector of Research and Developmentcweaber@tjoinc.com
Prepared By:	MCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5800Fax: 202.552.5798
Date Prepared:	July 23, 2021
Device Trade Name:	Klassic® Knee System
Device Common Name:	Total knee replacement system
Classification:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesisClass II
Product Codes:	JWH, OIY

Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
Patients with failed previous surgery where pain, deformity, or dysfunction persists ●
Correctable varus-valgus deformity and moderate flexion contracture ●
. Revision of a previously failed knee arthroplasty
Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, Porous, and the Klassic® Tibial Baseplate, Porous, which are indicated for cementless use.

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Device Description:

Predicate and Reference Devices:

The Klassic® Femur with Aurum® is substantially equivalent to the femoral components cleared as part of the Klassic® Knee System Femur (K112906) which serves as the primary predicate. The subject Klassic® Femur with Aurum® is identical to the predicate with respect to its intended use, articulating geometry, range of motion, function, and method of fixation. The subject femoral component differs from the predicate with respect to its material (i.e., the subject femoral component is made from titanium alloy with a titanium nitride surface: the predicate is made from CoCr alloy).

The titanium femoral components cleared as part of the Personalized Knee System (K142787) serve as a reference device. The subject device and Persona femoral components are made of identical materials with an identical titanium nitride surface.

Substantial Equivalence:

Non-Clinical Bench Testing and Engineering analyses were performed on the Klassic® Femur with Aurum® to evaluate Strength of the titanium nitride coating. Fatigue Testing, Knee Simulator Wear, Tibial-Femoral Stability Characteristics, Tibial-Femoral Contact Stress and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution. All results of the testing and analyses indicate that the subject Klassic® Femur with Aurum® is substantially equivalent to the predicate components. Additionally, the Klassic® Femur with Aurum® is also in compliance with LAL testing requirements for orthopedic implants.

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.