F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

Device Description

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

AI/ML Overview

This document is a 510(k) summary for a medical device (Hayes Medical, Inc. UniSyn Modular Hip System) seeking clearance from the FDA. It does not describe a traditional clinical study with acceptance criteria and device performance as one would find for a software or diagnostic device.

Instead, this 510(k) pertains to a physical orthopedic implant and is a "Special 510(k)" because the only change made to a previously cleared device (UniSyn Hip System, K003649) is the addition of a hydroxylapatite coating to the existing TPS coating on the surface of the bodies.

Therefore, the typical metrics, sample sizes, expert ground truth, and study types requested in your prompt (e.g., MRMC, standalone algorithm performance) are not applicable to this type of regulatory submission for a physical implant. The "acceptance criteria" here are met by demonstrating "substantial equivalence" to predicate devices, primarily through material and design information, rather than a performance study as you've outlined.

However, I can extract information related to the substantial equivalence argument, which is the closest analogy to "acceptance criteria" in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Argument for Substantial Equivalence)
For an implant, demonstrate:* - Same intended use as predicate device.* - Same material as predicate device (or equivalent).* - Same design features as predicate device (or equivalent).* - Same type of interface as predicate device (or equivalent).* - Safety and effectiveness are adequately supported by substantial equivalence information and materials data.	The Device (UniSyn Modular Hip System with HA Plasma Coating) is substantially equivalent because:

Explanation for the "Reported Device Performance": In a 510(k) for an implant device, particularly a Special 510(k) that involves a minor modification to a previously cleared device, the "performance" is demonstrated by showing that the modified device remains as safe and effective as the predicate device(s). This is achieved by comparing various attributes (intended use, materials, design, technological characteristics) to predicates and arguing that any differences do not raise new questions of safety or effectiveness. The text explicitly states: "The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission."

The remaining points of your request are not applicable to this 510(k) submission type, as it relates to a physical orthopedic implant device, not an AI/software device or a diagnostic requiring performance metrics like sensitivity/specificity derived from expert reviews.

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. This pertains to a physical implant, not a software or diagnostic device. Substantial equivalence for this type of device is typically demonstrated through engineering assessments, material characterization, and comparison to predicate devices, not through a "test set" of patient data in the context of performance metrics.

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. This submission does not involve a "ground truth" derived from expert consensus on patient data.

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

Not applicable. There is no "test set" in the context of expert adjudication for this physical 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 a physical implant, not an AI-assisted diagnostic or imaging system.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. "Ground truth" in the context of expert review or pathology is not relevant for this implant's regulatory clearance. The "truth" here is established via engineering principles, material science, and the regulatory history of predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. As above, there is no "training set" or need for "ground truth" establishment in this context.

Summary

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K062383 - Third Revised Section 9 510(k) Summary of Safety and Effectiveness

Defined in 21 CFR 807 In accordance with 21 CFR 807.92 (Summary)

Applicant's Name:	Hayes Medical, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95682	DEC 21 2001
Contact Person:	Luke Rose
Trade Name:	Body, UniSyn Modular Hip
Common Name:	Body, HA Plasma, Modular Hip
Classification Name:	Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Uncemented (21 CFR 888.3360, LWJ)Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented(21 CFR 888.3350, JDI)Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented or Non-Porous, Uncemented (21 CFR 888.3353, LZO)Prosthesis, Hip, Semi-Constrained, Uncemented,Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353, MEH)
Proposed Regulatory Class:	Class II
Device Classification Panel:	Orthopaedic
Substantially Equivalent To:	Hayes Medical Unisyn Modular Hip System (K003649)Hayes Medical HA Coated Consensus Hip System (K935453)Howmedica/Osteonics, Restoration Modular System (K022549)Biomet Orthopedics, Inc., HA Modular Reach Proximal Porous (K022463)

Intended Use:

Indications for use of the UNISYN™ HIP SYSTEM

A ) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.

F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa valga, developmental conditions, metabolic and turnorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

Device Description:

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K062383 - Third Revised Section 9 510(k) Summary of Safety and Effectiveness

Comparison to Cleared Device:

The only change made to the previously cleared UniSyn Hip System (K003649) is the addition of hydroxylapatite coating to the existing TPS coating on the surface of the bodies.

Substantial Equivalence Information

The intended use, material, design features and type of interface of the Body, HA Plasma, Modular Hip are substantially equivalent to Hayes Medical and competitive devices previously cleared for market. The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission.

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510(K) ROUTE SLIP SPECIAL 510(k) NUMBER: K062383 PANEL: OR DIVISION: DGRND BRANCH: OJDB ELECTRONIC SUBMISSION: N TRADE NAME: UNISYN HA PLASMA MODULAR HIP COMMON NAME: BODY, HA PLASMA, MODULAR HIP PRODUCT CODE: LAJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCE APPLICANT: HAYES MEDICAL, INC. SHORT NAME: HAYEMEDI CONTACT: LUKE ROSE DIVISION: ADDRESS: 1115 WINDFIELD WAY, SUITE 100 EL DORADO HILLS, CA 957629623 PHONE NO. (916) 355-7156 FAX NO. (916) 355-7190 MANUFACTURER: HAYES MEDICAL, INC. REG NO. 2952369 STERITEC, INC. 1647149 BIO-COAT, LLC 1833658 DATE ON SUBMISSION: 10-AUG-2006 DATE DUE POS: 09-SEP-2006 DATE RECEIVED IN ODE: 15-AUG-2006 DATE DECISION DUE: 14-SEP-2006 DECISION: ____________________________________________________________________________________________________________________________________________________________________ DECISION DATE: RECEIVED DUE POS SUPPLEMENTS SUBMITTED DUE OUT 27-SEP-2006 SOOI 25-SEP-2006 22-OCT-2006 27-OCT-2006 24-OCT-2006 11-DEC-2006 12-DEC-2006 06-JAN-2007 11-JAN-2007 S002 CORRESPONDENCE SENT DUE BACK COOL 06-SEP-2006 06-OCT-2006 HOLD LETTER C002 24 -OCT-2006 22-DEC-2006 HOLD LETTER

Is this 510(k) identified as a Class III device YES NO Is this 510(k) the result of additional information YES NO

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hayes Medical, Inc. % Dr. Luke Rose Director, OS&RA 1115 Windfield Way Suite 100 El Dorado Hills, California 95762

DEC 2 1 2006

Re: K062383

Trade/Device Name: UniSyn Modular Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, LZO, JDI, MEH Dated: December 11, 2006 Received: December 12, 2006

Dear Dr. Rose:

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

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Page 2 - Dr. Luke Rose

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

UniSyn Modular Hip System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Indications for use of the UNISYN™ HIP SYSTEM

A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.

B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

C) Proximal femoral fractures.

D) Avascular necrosis of the femoral head.

E) Non-union of proximal femoral neck fractures.

Prescription Use _X ________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Saubare Buell

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K062383

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.