The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed.

Device Description

The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "Short Citation® Femoral Stem." This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices.

This document describes a physical medical device (femoral stem for hip replacement), not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and "studies" related to the performance metrics, ground truth, expert consensus, and reader studies for AI/SaMD are not applicable in this context.

The "study" in this document refers to the regulatory review process for substantial equivalence to a predicate device, which is based on similar intended use, design, and sterilization. It doesn't involve performance metrics like sensitivity, specificity, or AUC, nor does it detail a clinical trial or a performance study in the way one would for an AI/SaMD.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not present or relevant to this type of regulatory submission for a physical orthopedic implant.

Here's how I can address the prompts based on the provided text, while clarifying the differences:

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

For this type of physical orthopedic implant, "acceptance criteria" and "reported device performance" are primarily related to safety, design similarity to a predicate device, and successful manufacturing validation. The document does not specify quantitative performance metrics in the way an AI/SaMD would (e.g., sensitivity, specificity).

The implicit "acceptance criteria" for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device.

Criteria	Reported Device Performance (as per 510(k))
Intended Use	"The subject hip stem is a single-use, sterile device intended for use in total hip replacement... intended for primary reconstruction of the proximal femur or revision total hip arthroplasty." - Similar to predicate.
Indications for Use	- Cementless primary hip surgery (osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity correction).- Treatment of nonunion, femoral neck/trochanteric fractures.- Revision procedures where other treatments failed. - Similar to predicate.
Design	"an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill." - Similar to predicate (Citation® TMZF® femoral stem K993768).
Sterilization	(Implicitly similar to predicate, as it's a sterile device). - Similar to predicate.
Biocompatibility (inferred)	(Materials like TMZF Titanium, CP titanium plasma spray, hydroxyapatite are standard in orthopedic implants, implying biocompatibility established for predicate). - Similar to predicate.
Mechanical Properties (inferred)	(Not explicitly detailed, but implied to be equivalent to predicate through design similarity and materials). - Similar to predicate.

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: Not applicable. This is not a study with a "test set" in the context of AI/SaMD performance evaluation. The "test" here is a regulatory review for substantial equivalence based on descriptive and comparative information.
Data Provenance: Not applicable. The submission refers to a comparison with a predicate device (Citation® TMZF® femoral stem K993768).

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. "Ground truth" in the context of expert consensus for AI performance is not relevant for this physical device submission. The "truth" is established by the accepted design and performance characteristics of the predicate device.

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

Not applicable. There is no "test set" or adjudication method in this regulatory process.

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 medical device, not an AI/SaMD. MRMC studies are not relevant for demonstrating substantial equivalence for an orthopedic implant.

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

Not applicable. This is a physical medical device.

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

Not applicable in the AI/SaMD sense. The "ground truth" for substantial equivalence is the predicate device itself and its established safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in this context.

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

Not applicable. There is no "training set" for a physical device.

Summary

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/Stryker
Howmedica

JAN ] 3 2006

K053528

510(k) Summary of Safety and Effectiveness for the

Short Citation® Femoral Stem

325 Corporate Drive Mahwah, NJ USA 07430

Proprietary Name:	Short Citation® Femoral Stem
Common Name:	Total Hip Joint Replacement Prosthesis
Classification Name and Reference	Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prostheses,21 CFR §888.3353
Regulatory Class:	Class II
Device Product Code:	87 MEH - prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous,calcium-phosphate,
	87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous, uncemented
For Information contact:	Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5412Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	December 16, 2005

Device Description

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Intended Use:

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. .

Substantial Equivalence:

The determination of the substantial equivalence of the Short Citation® hip stem is based on its similarities in intended use, design and sterilization to the Citation® TMZF® femoral stem (K993768, cleared January 21, 2000). Predicate device information is located in Appendix E.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Ms. Tiffani D. Rogers Specialist, Regulatory Affairs Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053528

Trade/Device Name: Short Citation® Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH, LZO Dated: December 16, 2005 Received: December 19, 2005

Dear Ms. Rogers:

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. Rogers

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) rms let 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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Mark N. Mellekerson

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

Enclosure

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1053528

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. .

Prescription Use X Use

Over-the-Counter

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K0535 28 510(k) Number

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.