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, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

Device Description

The Klassic® Knee System is being updated with additional thicknesses of Tibial Inserts, PS-Post and Additional All Poly Tibia PS-Post implants. Both proposed geometries are fabricated from both Standard Poly and Vitamin E UHMWPE (E-Link).

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the Klassic® Tibial Insert, PS-Post, and Klassic All Poly Tibia, PS-Post. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study of a novel AI-powered medical device.

Therefore, the requested information regarding acceptance criteria and a study proving a device (implying an AI or software as a medical device) meets these criteria cannot be fully extracted from the provided text. The document describes non-clinical testing and engineering analyses for mechanical components (tibial inserts), not a software or AI device.

However, I can extract the information that is present and explain why other requested information is not applicable to this document.

Information Extracted from the Document (Pertaining to Mechanical Device Evaluation):

A table of acceptance criteria and the reported device performance:

The document states: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate."

It lists the types of non-clinical tests performed:
- Femoral/Tibial Constraint Testing (ASTM F1223)
- Contact Area/Contact Stress (ASTM F2083)
- Post Fatigue Testing
- Range of Motion Evaluation
- Wear (ISO 14243-3)
- Tibial Insert Modular Disassembly Strength (ASTM F1814)
While the types of tests and the conclusion that criteria were met are stated, the specific quantitative acceptance criteria (e.g., minimum load for post fatigue, maximum wear rate) and the measured performance values are not provided in this summary document. This information would typically be in the full submission, not the public summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This document describes testing of physical components (tibial inserts), not an AI algorithm. Therefore, "sample size" would refer to the number of physical components tested, which is not specified. "Data provenance" such as country of origin or retrospective/prospective is not applicable in the context of mechanical engineering testing on manufactured parts.
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. Ground truth, in the context of an AI device, refers to expertly labeled data. Here, the "ground truth" (or standard) for mechanical performance is established by engineering standards (e.g., ASTM, ISO), not human experts labeling data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for human interpretation of complex data (e.g., medical images) to establish ground truth for AI training/testing. This document is about mechanical testing.
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. An MRMC study assesses the impact of an AI algorithm on human diagnostic performance. This document concerns the substantial equivalence of a physical medical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. Standalone performance refers to the performance of an AI algorithm without human involvement. This evaluation is of a mechanical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The "ground truth" for the mechanical components is defined by established engineering and biological safety standards (e.g., ASTM F1223, ASTM F2083, ISO 14243-3, ASTM F1814, and LAL testing for orthopedic implants). These are quantitative, objective measurements against pre-defined engineering and material science criteria.
The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and material science.
How the ground truth for the training set was established:

Not applicable (no training set).

Summary of Applicable (and Not Applicable) Information from the Provided Text:

Aspect	Information from Document	Justification/Notes
1. Acceptance Criteria & Reported Performance	Acceptance Criteria (Types of Tests): - Femoral/Tibial Constraint Testing (ASTM F1223)- Contact Area/Contact Stress (ASTM F2083)- Post Fatigue Testing- Range of Motion Evaluation- Wear (ISO 14243-3)- Tibial Insert Modular Disassembly Strength (ASTM F1814)- LAL testing requirements for orthopedic implants.Reported Performance: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate."	The document confirms that specific mechanical tests were performed against pre-determined acceptance criteria, and the device met these criteria. However, the quantitative values of the acceptance criteria (e.g., "must withstand X N without deformation") and the specific measured results from each test are not detailed in this summary. This is typical for a 510(k) summary, as the full detailed test reports are part of the confidential submission. The "reported device performance" is given as a qualitative statement of meeting the criteria.
2. Sample Size & Data Provenance (for test set)	Not disclosed.	This relates to mechanical testing of physical parts, not a data-driven AI model. The number of physical components tested is not provided. Data provenance (e.g., country, retrospective/prospective) is not relevant for this type of non-clinical, in-vitro testing.
3. Number & Qualifications of Experts for Ground Truth	Not applicable.	Ground truth in this context is established by objective engineering standards and measurements (e.g., ASTM, ISO), not by human expert consensus or labeling of data.
4. Adjudication Method (for test set)	Not applicable.	Adjudication is relevant for resolving discrepancies in human interpretation to establish ground truth for AI algorithms. This is mechanical testing.
5. MRMC Comparative Effectiveness Study	Not applicable.	This type of study evaluates the impact of AI on human reader performance for diagnostic tasks. The device in question is a physical knee implant.
6. Standalone (Algorithm Only) Performance	Not applicable.	This refers to the performance of an AI algorithm independent of human interaction. The device is a physical implant, not an algorithm.
7. Type of Ground Truth Used	Established engineering and material science standards (e.g., ASTM, ISO) and LAL testing.	The "ground truth" for evaluating the performance of the physical device components is based on well-defined and quantitative performance specifications derived from these industry-standard test methods to ensure mechanical integrity, biocompatibility, and safety.
8. Sample Size for Training Set	Not applicable.	This refers to data used to train an AI model. This device is a physical implant, not an AI.
9. How Ground Truth for Training Set was Established (If any)	Not applicable.	As there is no training set for an AI model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

September 8, 2023

Total Joint Othopedics, Inc. % Hollace Rhodes VP, Orthopedic Regulatory Affairs MCRA, LLC 803 7th Steet NW Floor 3 Washington. District of Columbia 20001

Re: K232414

Trade/Device Name: Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: August 10, 2023 Received: August 10, 2023

Dear Hollace 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.

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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); 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.

Lixin Liu -S

Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232414

Device Name

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

Indications for Use (Describe)

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070
Contact:	Mr. Chris WeaberDirector of Research and Development
Prepared By:	MCRA, LLC803 7th Street NW, Floor 3Washington, DC 20001Phone: 202.552.5800
Date Prepared:	August 10, 2023
Device Trade Name:	Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
Device Common Name:	Tibial Insert and All Poly Tibia
Classification:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis
	21 CFR 888.3565 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained uncemented prosthesis
	Class II
Product Code:	IWH, MBH, OIY

Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement 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 ●

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Device Description:

Predicate Devices:

The modified Klassic® System is substantially equivalent to the primary predicate Klassic® Knee System (K112906), and other identified predicates from the Klassic® Knee System (K162422, K183596) with respect to design, materials, function and indications for use.

Comparison of Technological Characteristics:

The modified Klassic® Knee System features the same materials (GUR 1050 UHMWPE -"Standard Poly" and Vitamin E UHMWPE = "E-Link"), same use in primary or revision Total Knee Arthroplasty, and same EO sterilization compared to the predicate Klassic® Knee System (K112906, K162422, K183596).

Differences include the addition of an All-Poly Tibia, PS-Post implant as compared to the cleared All-Poly Tibia, Ultra-PS and All-Poly Tibia, CR-Congruent versions (K162422), and three additional thicknesses (18, 21, 24mm) added to the already cleared Tibial Inserts, PS-Post (K183956), which are identical in thickness to those of the cleared Tibial Inserts, PS-Max (K202740).

Discussion of Non-Clinical Testing/Performance Data:

Testing and engineering analyses were performed to evaluate the subject components. Additionally, the Klassic® Revision System is in compliance with LAL testing requirements for orthopedic implants.

Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:

Femoral/Tibial Constraint Testing (ASTM F1223)
Contact Area/Contact Stress (ASTM F2083) ●
Post Fatigue Testing ●
Range of Motion Evaluation
Wear (ISO 14243-3)
Tibial Insert Modular Disassembly Strength (ASTM F1814) ●

Conclusion:

Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.

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.