GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert by StelKast, Inc.

The GENFlex2 Total Knee System is intended for:
· Total knee replacement due to osteoardis, theumatoid arthritis, and/or post-traumatic degenerative problems.
· Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.

Device Description

The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a knee replacement system component. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to its performance in a clinical or diagnostic setting. Therefore, most of the information requested in the prompt, such as an acceptance criteria table, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic devices, is not applicable to this submission type.

The document discusses bench testing to demonstrate the physical performance of the device (A/P constraint testing and contact area analyses), but these are engineering verification tests, not clinical performance studies with human subjects or expert readers establishing ground truth for diagnostic accuracy.

Here's a breakdown of the relevant information provided in the given text, and why other parts of your request cannot be fulfilled:

Acceptance Criteria and Device Performance (Not directly addressing the prompt for diagnostic/AI devices):

A/P constraint testing: Performed on the modified GENFlex2 Ultra-Congruent CR Tibial Inserts and compared to results for the predicate inserts. The statement says, "All results demonstrate that the modified device performs similarly to the predicate device."
Contact area analyses: Performed on the modified and predicate devices. Again, "All results demonstrate that the modified device performs similarly to the predicate device."
Limulus Amebocyte Lysate (LAL) testing: Performed to establish that the device meets pyrogen limit specifications.

Table of Acceptance Criteria and Reported Device Performance:

The document states that the "modified geometry of the Ultra-Congruent CR Tibial Insert meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific numerical acceptance criteria or the exact reported performance values from these engineering tests. It only states that the performance was "similar" to the predicate device and met pyrogen limits.

Applicable Information from the Text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: "meets the pre-determined acceptance criteria for the verification activities" (no specific numerical criteria provided). "meets pyrogen limit specifications."
- Reported Device Performance:
  - A/P constraint testing: "All results demonstrate that the modified device performs similarly to the predicate device."
  - Contact area analyses: "All results demonstrate that the modified device performs similarly to the predicate device."
  - LAL testing: Confirmed device meets pyrogen limit specifications.
Sample sized used for the test set and the data provenance: Not applicable in the context of clinical/diagnostic AI device testing. The tests mentioned are engineering bench tests, not involving human data or a "test set" in the diagnostic sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the engineering specifications and performance of the predicate device, for which the new device demonstrated "similarity."
The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a physical medical device (knee implant component) that demonstrates substantial equivalence through engineering bench testing and material compatibility, rather than a study on a diagnostic AI device requiring the detailed "acceptance criteria" and "ground truth" information for accuracy performance.

Summary

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January 19, 2018

StelKast, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K173875

Trade/Device Name: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert 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: December 20, 2017 Received: December 21, 2017

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. 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 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K173875

Device Name

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

Indications for Use (Describe)

The GENFlex2 Total Knee System is intended for:

· Total knee replacement due to osteoardis, theumatoid arthritis, and/or post-traumatic degenerative problems.

· Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The device is intended for cemented use only.

Type of Use (Select one or both, as applicable)
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✖ 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:	StelKast, Inc.200 Hidden Valley RoadMcMurray, PA 15317Phone: 724.731.2208Fax: 727.941.5987
Contact:	Mr. David StumpoVice President of Product Development
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	December 20, 2017
Device Trade Name:	GENFlex2 Total Knee System – Ultra-Congruent CR TibialInsert
Device CommonName:	Total Knee Replacement System
Classification:	21 CFR 888.3560Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisClass II
Product Codes:	JWH, OIY
Indications for Use:	The GENFlex2 Total Knee System is intended for:• Total knee replacement due to osteoarthritis,osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.• Revision of failed previous reconstructions wheresufficient bone stock and soft tissue integrity arepresent.

The device is intended for cemented use only.

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Device Description: The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.
The GENFlex2 Ultra-Congruent CR Tibial Insert is Predicate Devices: substantially equivalent to the predicate inserts of the GENFlex2 Total Knee System (K162222), originally cleared as the Proven Total Knee System (K980276, K063211, and K122883) with respect to intended use, materials, design, range of available sizes, method of fixation, and performance characteristics. The information summarized in the Design Control Activities Summary demonstrates that the modified geometry of the Ultra-Congruent CR Tibial Insert meets the pre-determined acceptance criteria for the verification activities.
A/P constraint testing was performed on the modified Substantial GENFlex2 Ultra-Congruent CR Tibial Inserts and compared Equivalence: to results for the predicate inserts. Contact area analyses were performed on the modified and predicate devices. All results demonstrate that the modified device performs similarly to the predicate device.

Limulus Amebocyte Lysate (LAL) testing was performed on the implants to establish that the device meets pyrogen limit specifications.

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.