· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
· Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of a previously failed hip arthroplasty.
Patients who require a total hip replacement.

Device Description

The Total Joint Orthopedics Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are permanently implanted devices for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The subject inserts are fully compatible for use with the previously cleared Klassic HD® Hip System and are manufactured from UHMWPE crosslinked by gamma irradiation and infused with vitamin E. The subject inserts are sterilized by ethylene oxide gas and intended for single-use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, a hip implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing details of a study on device performance that would typically include acceptance criteria and specific performance metrics like those for an AI/ML diagnostic tool. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this text.

However, I can extract the following:

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities." It also lists the types of tests performed.

Test	Acceptance Criteria	Reported Device Performance
Lever out strength	Pre-determined	Met acceptance criteria
Push Out Strength	Pre-determined	Met acceptance criteria
Torque Disassembly Strength	Pre-determined	Met acceptance criteria
Impingement	Pre-determined	Met acceptance criteria
Wear	Pre-determined	Met acceptance criteria
LAL testing	Requirements	In compliance

Note: The specific numerical values for the acceptance criteria and the device's performance are not provided in this summary. The document only confirms that the "pre-determined acceptance criteria" were met.

The remaining questions (2-9) are largely not applicable or cannot be answered from the provided text, as this is a regulatory submission for a physical orthopedic implant, not a software or AI/ML-based diagnostic device. The document describes mechanical performance testing and equivalency to a predicate device, not a "study" in the sense of clinical trials or AI model validation.

Here's why and what limited information could be inferred:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not a "test set" of data. The document does not specify the number of implants tested in each category.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance tests is established by engineering standards and measurements, not expert radiologists or similar medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for mechanical testing of an implant.
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: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be physical measurements and established engineering standards and methodologies. The document does not elaborate further.
8. The sample size for the training set: Not applicable. This is for AI/ML models. For a physical device, "training" would refer to design iterations and early testing.
9. How the ground truth for the training set was established: Not applicable for AI/ML sense. For device development, "ground truth" during design would involve engineering principles, materials science, and testing against industry standards.

Summary

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Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106

October 27, 2017

Re: K173104

Trade/Device Name: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: OQG, LPH, MBL, LWJ Dated: September 28, 2017 Received: September 29, 2017

Dear Mr. Chris Weaber:

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 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);

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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 Industry and Consumer Education (DICE) 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.

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) K173104

Device Name

Klassic HD® Hooded Acetabular Insert with E-Link® Poly Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

Indications for Use (Describe)

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

· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
· Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of a previously failed hip arthroplasty.
Patients who require a total hip replacement.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. 510(k) Summary

Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070
Contact:	Mr. Chris WeaberProduct Development, Regulatory Manager
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	September 29, 2017
Device Trade Name:	Klassic HD® Hooded Acetabular Insert with E-Link® PolyKlassic HD® Low Profile Acetabular Insert with E-Link®Poly
Common Name:	Acetabular Insert
Classifications:	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
	Class II
Product Codes:	OQG, LPH, MBL, LWJ

Indications for Use:

The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
Those patients with failed previous surgery where pain, deformity, or dysfunction . persists.
Revision of a previously failed hip arthroplasty. ●
Patients who require a total hip replacement. .

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Device Description:

Predicate Devices:

The modified Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Inserts with E-Link® Poly are substantially equivalent to the predicate Klassic HD® Acetabular Inserts with E-Link® Poly (K141972) with respect to indications, design, materials and function. The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

The Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are substantially equivalent to the predicate components based on indications for use, technological characteristics, design, material, mechanical performance testing, packaging and sterilization. Verification Activities, including testing and engineering analyses, were performed for Lever out strength. Push Out Strength, Torque Disassembly Strength, Impingement and Wear. The subject Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly did not create a new worst case as compared to the predicate. The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.