The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): 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® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Klassic HD® Hip System, specifically focusing on the Klassic HD® Acetabular Insert with XLPE. This filing addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria in a clinical setting in the way an AI/ML medical device might.

Therefore, the information required to answer your specific questions about acceptance criteria and a study that proves the device meets the acceptance criteria regarding AI/ML device performance (e.g., sensitivity, specificity, expert ground truth, MRMC studies) is not present in the provided document.

The document discusses non-clinical bench testing to support substantial equivalence. While it mentions "pre-determined acceptance criteria" for this bench testing, it does not specify what those criteria are or provide detailed results from a clinical study.

Here's an breakdown of why your questions cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: The document states that "bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices." It also says the device "met the pre-determined acceptance criteria." However, it does not list these specific criteria (e.g., thresholds for wear, strength, etc.) nor does it present the quantitative results against those criteria.
Sample sizes used for the test set and the data provenance: This refers to clinical data for performance evaluation. The document only mentions "non-clinical bench testing" and "extensive material characterization." There is no mention of a human test set, data provenance (country, retrospective/prospective), or data collection methods for a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts for the test set: Not applicable as no clinical test set using expert judgment is described.
Adjudication method for the test set: Not applicable as no clinical test set using expert judgment is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The study described is non-clinical bench testing, not a study involving human readers or cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would relate to engineering standards, material properties, and mechanical performance metrics (e.g., ultimate tensile strength, wear rates). The specific metrics are not detailed, but the document mentions "material characterization," "sterility validation," "Push Out, Lever Out, Axial Torque Disassembly and Impingement testing."
The sample size for the training set: Not applicable. This document describes a physical medical device (hip implant), not an AI/ML model that requires training data.
How the ground truth for the training set was established: Not applicable, as there is no AI/ML model or training set discussed.

In summary, the provided document details a 510(k) submission for a physical medical device (hip implant), focusing on non-clinical bench testing for substantial equivalence. It does not provide the kind of information typically found in an AI/ML device submission regarding clinical performance, expert readers, or ground truth establishment relevant to AI algorithm validation.

Summary

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

October 19, 2016

Total Joint Orthopedics, Inc. Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106

Re: K161073

Trade/Device Name: Klassic HD® Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ polymer/metal semi-constrained porous-coated uncemented prothesis Regulatory Class: Class II Product Code: LPH, MBL, LWJ, LZO Dated: September 16, 2016 Received: September 19, 2016

Dear Mr. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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) Unknown K161073

Device Name Klassic HD® Hip System

Indications for Use (Describe)

· 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Device Trade Name:	Klassic HD® Hip System
Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106U.S.A.Phone: 801.486.6070FAX: 801.486.6117
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: 202.552.5800Fax: 202.552.5798
Date Prepared:	April 15, 2016
Common Name:	Hip prosthesis, UHMWPE acetabular insert
Classification:	21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis21 CFR 888.3360 Hip Joint femoral (Hemi-hip) metalliccemented or uncemented
Class:	Class II
Product Codes:	LPH, MBL, LWJ, LZO

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:

Total Joint Orthopedics Klassic HD® Hip System (K100445, K141972) .

Reference Devices:

Ortho Development Corporation Escalade Acetabular Cup System (K103384)
Wright Medical Technology, Inc. LINEAGE® A-CLASS™ (K052026) .

Non-Clinical Testing

Non-clinical bench testing was conducted on the Klassic HD® Acetabular Insert with XLPE to support a determination of substantial equivalence to the predicate devices. Testing included extensive material characterization both before and after accelerated aging, sterility validation, and Push Out, Lever Out, Axial Torque Disassembly and Impingement testing with the Klassic HD® acetabular cup, femoral stem and femoral head. Bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices.

Substantial Equivalence

The Klassic HD® Acetabular Insert with XLPE is substantially equivalent to the predicate devices based on indications for use, technological characteristics, design, material, mechanical performance testing, packaging and sterilization. The information summarized in the performance testing demonstrates that the Klassic HD® Acetabular Insert with XLPE met the pre-determined acceptance criteria. Additionally, LAL testing has been performed to establish that the Klassic HD® Acetabular Inserts with XLPE meet the specified 20EU/device limit.

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.