Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
The DePuy Solution System Hip System is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Device Description

The DePuy Solution System Hip Prosthesis is manufactured from ASTM F-75 Cobalt Chromium-Molybdenum alloy and has a sintered cobalt-chrome-molybdenum alloy bead porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the polished neck and tapered stem tip region. The DePuy Solution System Hip Prosthesis is a single use device.

AI/ML Overview

The regulatory submission K030979 for the DePuy Solution System Hip Prosthesis does not contain acceptance criteria or a study proving the device meets said criteria in the way typically expected for AI/ML-driven medical devices.

Instead, this submission is a traditional 510(k) premarket notification for a medical device (a hip prosthesis) that falls under the "substantial equivalence" pathway. This means the device's clearance is based on its similarity to previously cleared predicate devices, rather than a performance study against predefined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance for an AI/ML device is not applicable to this submission.

Here's an breakdown based on the provided text, specifically addressing why the requested information isn't present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not applicable for a 510(k) based on substantial equivalence. Performance criteria against specific metrics are not presented.	Device is considered substantially equivalent to predicate devices (DePuy Vision Solution Hip Prosthesis, K953703, and DePuy AML Hip Prosthesis, K012364) based on similarities in design, materials, sterilization processes, and intended use. No specific performance metrics (e.g., accuracy, sensitivity, specificity) were measured or reported to 'meet' acceptance criteria.

Regarding the Study That Proves the Device Meets Acceptance Criteria:

The "study" presented here is a substantiation of substantial equivalence rather than a performance study against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. There was no "test set" in the context of evaluating an AI/ML algorithm's performance. The basis for equivalence relies on comparing the device's attributes (design, materials, intended use) to predicate devices, not on clinical data demonstrating performance in a "test set."
Data Provenance: Not applicable. No clinical data or image data set was analyzed to demonstrate performance. The submission refers to the characteristics of the device itself and its predicates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. No ground truth was established by experts for a test set, as no performance study was conducted.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was utilized.

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

MRMC Study: No. This submission pertains to a physical orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No. This is not an algorithm; it is a physical medical device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. The concept of "ground truth" as used in AI/ML performance evaluation (e.g., pathology, expert consensus, outcomes data) is not relevant to a substantial equivalence determination for a hip prosthesis. The "truth" in this context is whether the new device's characteristics are sufficiently similar to legally marketed predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Summary for K030979:

The DePuy Solution System Hip Prosthesis received 510(k) clearance based on its substantial equivalence to two predicate devices: the DePuy Vision Hip Prosthesis (K953703) and the DePuy AML Hip Prosthesis (K012364). The basis for this determination was "similarities of design, same materials, identical sterilization processes, and the same intended use." This regulatory pathway does not require clinical performance trials demonstrating effectiveness against predetermined acceptance criteria in the manner expected for AI/ML devices. Therefore, the submission does not contain the types of data (e.g., test sets, ground truth, expert adjudication, MRMC studies) typically associated with evaluating AI/ML device performance.

Summary

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K030979

NAME OF SPONSOR: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910 510(K) CONTACT: Karla A. Ham Senior Regulatory Associate Phone: (574) 371-4925 FAX: (574) 371-4987 DePuy Solution System Hip Prosthesis TRADE NAME: COMMON NAME: Cemented or cementless porous-coated hip prosthesis CLASSIFICATION: Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis DEVICE PRODUCT CODE: 87LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Vision Solution Hip Prosthesis, K953703 DePuy AML Hip Prosthesis, K012364

DEVICE DESCRIPTION:

510(k) Summary

INTENDED USE AND INDICATIONS:

The DePuy Solution System Hip Prosthesis is intended for use in total hip arthroplasty in either a cementless (by biological tissue ingrowth into the porous coating) or cemented application (in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement). Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

1. Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
1. Certain cases of ankylosis.

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510(k) Summary (cont.)

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities of design, same materials, identical sterilization processes, and the same intended use, DePuy believes that the modified DePuy Solution System Hip Prosthesis is substantially equivalent to the previously cleared Vision Hip Prosthesis (K953703) and the DePuy AML Hip Prosthesis (K012364).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three birds in flight, arranged in a row. The birds are facing to the right. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the birds.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karla A. Ham Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K030979

Trade/Device Name: DePuy Solution System® Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: March 25, 2003 Received: March 28, 2003

Dear Ms. Ham:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Karla A. Ham

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milkusen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko20979

DePuy Solution System® Hip Prosthesis Device Name:

Indications for Use:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or 1. congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck. 3.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, ব surface replacement arthroplasty, or total hip replacement.
న్. Certain cases of ankylosis.

The DePuy Solution System Hip System is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of General. Restorative
and Neurological Devices

510(k) Number. K030979

Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)

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.