. 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 Klassic HD™ Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version. The Klassic HD™ Hip System can be mated with metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Klassic HD™ Hip System." It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a previously cleared device. However, it does NOT include the specific details needed to answer most of your detailed questions about acceptance criteria and study particulars for a standalone AI algorithm.

This document pertains to a physical orthopedic implant (hip system), not software, AI, or an imaging device. Therefore, many of your questions about AI study design, such as sample size for test/training sets, expert adjudication, MRMC studies, and ground truth types like pathology or outcomes data, are not applicable in this context.

Here's what can be extracted and what cannot:

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

Acceptance Criteria (General Description)	Reported Device Performance (General Description)
Pre-determined acceptance criteria identified in the Design Control Activities Summary for burst strength, fatigue, post-fatigue burst strength, and pull-off testing. (Specific numerical/statistical criteria are not provided in this document).	The test results demonstrate that the pre-determined acceptance criteria... were met. (Specific numerical/statistical results are not provided in this document).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified. The document only mentions "the company performed burst strength testing, fatigue testing, post-fatigue burst strength testing and pull-off testing." It does not state how many units were tested for each.
Data Provenance: Not applicable in the context of device performance testing. These are material/mechanical tests, not patient data trials.

3. 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):

This question is not applicable. The "ground truth" here refers to the physical properties and mechanical performance of the femoral heads. These are established through standardized engineering tests, not expert consensus or clinical evaluation in the way an AI algorithm's ground truth would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are relevant for subjective assessments or when multiple human readers interpret data. For mechanical testing, the "ground truth" is typically the measured value against a pre-defined engineering specification.

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:

This question is not applicable. This document describes the testing of a physical hip implant component, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The device is a physical hip system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" here is based on engineering specifications and measurements from mechanical testing (burst strength, fatigue, post-fatigue burst strength, and pull-off testing). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This question is not applicable. There is no training set for a physical device being evaluated through mechanical testing.

9. How the ground truth for the training set was established:

This question is not applicable. There is no training set mentioned in this document.

In summary: This 510(k) pertains to a physical medical device (hip implant) and its mechanical properties. The provided text outlines that mechanical tests were performed to demonstrate substantial equivalence, and those tests met pre-determined acceptance criteria. However, it lacks the specific numerical results of those tests and the detailed methodologies that would be required to answer questions typically asked about AI/software device studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

December 23, 2014

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

Re: K143407 Trade/Device Name: Klassic HD™ Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LPH, MBL Dated: November 26, 2014 Received: November 28, 2014

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.

Lori A. Wiggins -S

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

Enclosure

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4. Indications for Use

510(k) Number (if known): K143407 (page 1/1)

Device Name: Klassic HD™ Hip System

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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5. 510(k) Summary

Contact:	Mr. Chris WeaberManufacturing Development Engineer
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: 202.552-5800Fax: 202.552.5798
Date Prepared:	November 26, 2014
Device Trade Name:	Klassic HD™ Hip System
Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117
Classifications:	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesi
	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
	Class II
Product Codes:	LZO, LPH, MBI

Reason for Special 510(k) Submission:

The purpose of this Special 510(k) is to add ceramic femoral heads to the Klassic HD™ Hip System. There have been no changes to the intended use of the device or its fundamental scientific technology.

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.

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Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Revision of a previously failed hip arthroplasty.
o Patients who require a total hip replacement.

Device Description:

Predicate Devices:

The modified Klassic HD™ Hip System is substantially equivalent to the predicate Klassic HD™ Hip System (K100445) with respect to indications, design, and function.

Substantial Equivalence:

The company performed burst strength testing, fatigue testing, post-fatigue burst strength testing and pull-off testing of the ceramic femoral heads. The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met.

Conclusion

The Klassic HD™ Hip System when mated with a ceramic femoral head is substantially equivalent to previously cleared devices with respect to its indications for use, design, and function.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.