The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.

The SC Femoral Hip Stem is indicated for use with or without bonc cement.

The SC Acetabular Cup is for use with bone cement only.

Device Description

The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.

AI/ML Overview

The provided text is a 510(k) summary for the "SC Total Hip System." This document is a premarket notification to the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe or report on a study performed to demonstrate specific acceptance criteria for the device's performance through clinical trials or a specific performance study.

Instead, the summary focuses on demonstrating substantial equivalence to existing, legally marketed hip systems (predicate devices) based on design, function, materials, and intended use. The FDA's letter confirms this substantial equivalence.

Therefore, many of the requested elements for describing an acceptance criteria study and its results cannot be populated from the provided text.

Here's a breakdown of why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The "acceptance criteria" here is implicitly that the device is "substantially equivalent" to predicate devices, meaning it should perform comparably to devices already on the market.
Reported Device Performance: No specific quantitative performance data (e.g., success rates, complication rates, longevity figures) from a dedicated study are reported in this 510(k) summary. The summary only generally states: "The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma."

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative performance metrics for a dedicated study. The implicit acceptance criterion is "substantial equivalence" to predicate devices based on design, function, materials, and intended use.	No specific quantitative performance data from a dedicated study is reported in this 510(k) summary. The device is described as functioning "to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma."

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

Not applicable / Not provided. A specific "test set" for a performance study is not described. The substantial equivalence determination is based on a comparison to predicate devices, not on a new clinical study with a test set of patients.

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)

Not applicable / Not provided. There was no specific "test set" requiring expert ground truth establishment for a performance study.

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

Not applicable / Not provided. There was no specific "test set" requiring adjudication.

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 / Not provided. This device is a total hip system (an implant), not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study.

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

Not applicable / Not provided. This device is a mechanical implant, not an algorithm, so a standalone performance study in this context is irrelevant.

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

Not applicable / Not provided. No specific "ground truth" was established for a new clinical performance study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices already on the market.

8. The sample size for the training set

Not applicable / Not provided. This device is a mechanical implant. There is no "training set" in the context of an algorithm or AI.

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

Not applicable / Not provided. (See point 8).

Summary of what the document does provide:

Device Name: SC Total Hip System
Intended Use: Treatment of severely disabled hip joints from painful osteo-, rheumatoid, and post-traumatic arthritis, late stages of avascular necrosis, and revision of previous hip surgeries.
Materials: Ti6Al-7Nb Titanium alloy, CoCrMo alloy, Ultra High Molecular Weight Polyethylene (UHMWPE).
Function (general): To provide pain relief and improved function to the disabled hip.
Predicate Devices: SL-Plus Hip Stem, Zweymuller SL Hip System, Lester Press Fit Hip System, Alloclassic Zweymuller SL Hip Stem.
Basis for market clearance: Substantial equivalence to these predicate devices based on design, function, materials, and intended use.

This 510(k) summary is a regulatory filing asserting equivalence, not a report on a detailed clinical performance study with specific acceptance criteria and outcome measurements.

Summary

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K031474

OCT 1 5 2003

Summary of Safety and Effectiveness for the SC Total Hip System

This safety and effectiveness summary for the SC Total Hip System is provided per Section 513(i)(3) of the Food, Drug and Cosmetic Act

l. Submitter : Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562

Contact Person : Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562 Telephone: ( 909 ) 304-9001

Date Prepared: May 3, 2003

Tradename: SC Total Hip System Common Name: Total Hip System Classification Name: Hip joint metal /polymer semi-constrained cemented prosthesis ( 888.3350 )

3. Predicate or legally marketed devices which are substantially equivalent :

SL-Plus Hip Stem ( Plus Orthopedics )
Zweymuller SL Hip System ( AlloPro ) ●
Lester Press Fit Hip System ( Kirschner ) ●
Alloclassic Zweymuller SL Hip Stem ( Sulzer Medica ) ●

4. Description of the device :

Materials: The devices are manufactured from Ti6Al-7Nb Titanium alloy, CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

5. Intended Use:

The SC Total Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

The SC Femoral Hip Stern is indicated for use with or without bone cement. The SC Acctabular Cup is for use with bone cement only.

Comparison of the technological characteristics of the device to predicate and legally marketed devices :

There are no significant differences between the SC Total Hip System and other total hip systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal are three stylized human profiles facing to the right, with flowing lines above them.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive, Suite A Marietta, CA 92562

Re: K031474 Trade/Device Name: SC Total Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ Dated: September 17, 2003 Received: September 22, 2003

Dear Mr. Williams:

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 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.

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Page 2 - Mr. Roger Williams

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) 594-4659. 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 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. Millen

Celia 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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Page I of 1

510(k) Number ( if known ) : K031474

Device Name : SC Total Hip System

Indications For Use :

The SC Femoral Hip Stem is indicated for use with or without bonc cement.

The SC Acetabular Cup is for use with bone cement only.

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

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription use ( PER 21 CFR 801.109)

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

( optional format 1-2-96 )

Mark N. Milliman

vision Sign-Of Restorative and Neurologic

510(k) Number K031474 mna

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.