The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Examples of specific indications for use of the Restoration® Modular System include, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Bowed Plasma Stem to create a line extension called the Restoration® Modular Bowed Plasma Trislot Stem. The subject components are for use with the previously cleared Restoration® Modular Distal Stem components.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Restoration® Modular Hip System, specifically the Restoration® Modular Bowed Plasma Trislot Stem. This is a submission for a medical device (hip prosthesis) and the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria for a new type of device or an AI/software as a medical device.

Therefore, the requested information about acceptance criteria and the study proving the device meets them (especially those related to AI/software performance, ground truth, experts, and training sets) is not applicable to this type of regulatory submission.

Here's why and what information is relevant from the provided text:

Key Takeaways from the Document:

Device Type: This is a physical medical device (femoral hip prosthesis components), not an AI/software-based diagnostic or therapeutic device.
Regulatory Path: It's a "Special 510(k) Premarket Notification" for a "line extension." This path is used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or the fundamental scientific technology of the device. The primary goal is to demonstrate substantial equivalence to the predicate device.
Proof of Equivalence: The document states: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical."

Answer to the specific questions (modified for context):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Substantial Equivalence (Implicit): The device (Restoration® Modular Bowed Plasma Trislot Stem) must demonstrate equivalent mechanical strength, intended use, material, manufacturing methods, packaging, and sterilization to its predicate devices (Restoration® Modular Bowed Plasma Stem and other Restoration® Modular Distal Stem components).
- Reported Device Performance: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." The document does not provide specific quantifiable performance metrics (e.g., fatigue life numbers, stress data) in this summary, but asserts that the testing showed equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the context of an AI/software device. For a physical device like a hip implant, "sample size" usually refers to the number of components tested in mechanical studies (e.g., fatigue or tensile tests). This specific information (number of components tested) is not detailed in the summary. Data provenance is not a typical concern for this type of mechanical testing.
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. "Ground truth" established by experts is relevant for diagnostic or AI systems. For mechanical testing of an implant, the "ground truth" is determined by established engineering standards and physical measurements, not expert human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to expert review for diagnostic accuracy, not mechanical testing.
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 study design is specifically for evaluating diagnostic AI or image interpretation systems.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. As noted above, the "ground truth" for demonstrating substantial equivalence for a mechanical implant would be established through engineering measurement against established performance standards and predicate device data.
The sample size for the training set:
- Not applicable. This concept pertains to machine learning models, not physical devices.
How the ground truth for the training set was established:
- Not applicable. This concept pertains to machine learning models, not physical devices.

In summary, this document is a regulatory submission for a physical hip implant. The "study" referenced is mechanical testing and analysis, which determined that the new components are "substantially equivalent" to predicate devices, thereby meeting the regulatory requirement for market clearance. The detailed specifics of those mechanical tests (e.g., number of samples, specific loads, quantifiable results) are not provided in this summary but are implicit in the FDA's clearance decision.

Summary

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Line Extension to the Restoration® Modular Hip System

K051363 p1/2

Special 510(k) Premarket Notification

JUN 2 3 2005

Special 510(k) Summary of Safety and Effectiveness:

Line Extension to the Restoration® Modular Hip System

Proprietary Name:	Restoration® Modular System
Common Name:	Femoral Hip Prosthesis
Proposed Regulatory Class:	Class II
Classification:	Hip joint metal/ceramic/polymer semi-constrained cemented or
	nonporous uncemented prosthesis, 21 CFR §888.3353,
	Prosthesis, hip, semi-constrained, metal/polymer, uncemented, 21
	CFR §888.3350,
	Hip joint metal/polymer/metal semi-constrained porous-coated
	uncemented prosthesis, 21 CFR §888.3358,
	Hip joint metal/polymer constrained cemented or uncementedprosthesis, 21 CFR §888.3310,Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis, 21 CFR §888.3390,Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis, 21 CFR §888.3360.
Device Product Code:	87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY,and 87 KWL
For Information contact:	Karen AriemmaSenior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Telephone: (201) 831-5718Fax: (201) 831-6038Email: karen.ariemma@stryker.com
Date Summary Prepared:	May 24, 2005

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Device Description

Indications for Use

Substantial Equivalence

The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

JUN 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Dr. Mahwah, New Jersey 07430

Re: K051363

Trade/Device Name: Restoration® Modular System_ Regulation Number: 21 CFR 888.3310, 888.3353, 888.3350. 888.3360, 888.3390 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer semiconstrained cemented prosthesis, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis, Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, Hip joint femoral (Hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II

Product Code: JDI, LWJ, MEH, LZO, LPH, KWZ, KWY, KWL Dated: May 24, 2005 Received: May 25, 2005

Dear Ms. Ariemma:

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.

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Page 2 – Ms. Karen Ariemma

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advisou that I Drainstan that your device complies with other requirements of the Act that I Dr has made a wond regulations administered by other Federal agencies. You must or any I vith 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your he FDA finding of substantial equivalence of your device to a legally premaince noticated.com "The 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 If you active 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 other general mionnal 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/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Restoration® Modular System

Indications For Use:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis,
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, and .

AND/OR

Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Prescription Use

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of of 1_ Sion Sign-Off) ision of General, Restorative and Neurological Devices

s1363

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.