The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Description

This stem has a flat rectangular cross sectional geometry that is intended to withstand rotational stress. The large proximal surfaces transmits stress to the greater trochanter and the arch of the calcar. This geometry achieves high primary stability and lays the foundation for good secondary stability. This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.

AI/ML Overview

The prompt requests information for which there is no data. The provided text is a 510(k) summary for a medical device (UNI Hip Stem), primarily focusing on its equivalence to a predicate device and non-clinical testing. It does not contain a study that proves the device meets acceptance criteria in the way medical imaging AI or diagnostic devices would, nor does it provide the detailed statistical information asked for in the request.

Here's a breakdown of why I cannot fulfill the request based on the provided text, and what information is available:

Missing Information:

Acceptance Criteria (for performance study): The document doesn't define quantitative acceptance criteria for a performance study in the context of diagnostic accuracy, sensitivity, specificity, etc. It focuses on the device's physical properties and intended use.
Reported Device Performance (against specific criteria): There's no performance data presented in the statistical sense (e.g., sensitivity, specificity, AUC).
Sample Size (test set), Data Provenance: No information on a test set, as no performance study of that nature was conducted or reported.
Number of Experts, Qualifications, Adjudication Method: These are relevant for studies involving human interpretation or ground truth establishment, which is not present here.
MRMC Comparative Effectiveness Study: Not applicable or mentioned.
Standalone Performance: Not applicable or mentioned in the context of AI.
Type of Ground Truth: Not applicable; the device is an implant, not a diagnostic tool requiring ground truth like pathology.
Sample Size (training set): Not applicable; the device is a physical implant, not a machine learning model.
How Ground Truth for Training Set was Established: Not applicable.

Information from the document that is relevant to a "device acceptance" in a general sense:

Acceptance Criteria (General for this type of device): The general acceptance criteria for this type of device are implicitly linked to its substantial equivalence to a legally marketed predicate device (SL-PLUS Stem) and its ability to pass relevant non-clinical tests.
- Predicate Device Equivalence: The UNI Hip Stem must be substantially equivalent to the SL-PLUS Stem, meaning it has the same intended use, shared technological characteristics, and any differences do not raise new questions of safety or effectiveness.
- Performance Standard: Fatigue testing per ISO 7206-4.
Reported Device Performance (General for this type of device):
- "Fatigue testing per ISO 7206-4 was successfully performed." This is the only explicit "performance" reported in the non-clinical tests section. The document doesn't quantify the results beyond "successfully performed."
Study that Proves Acceptance:
- Non-clinical Tests: Fatigue testing per ISO 7206-4. This test was "successfully performed." The report does not provide details on the study's methodology, sample size for the test, or the specific results (e.g., number of cycles, load levels).

Summary Table (based on available information):

Acceptance Criteria (General)	Reported Device Performance (General)
Substantially equivalent to predicate device (SL-PLUS Stem).	"The UNI Stem is similar to the SL-PLUS Stem. Both stems have the same overall stem profile and are manufactured from similar titanium alloys... The indications for use are the same for both stems." "Minor change in material, removal of lateral suture holes... slightly smaller cross section and head offset." FDA deemed it substantially equivalent (K024134).
Successful Fatigue testing per ISO 7206-4.	"Fatigue testing per ISO 7206-4 was successfully performed."

This document focuses on regulatory clearance for a physical orthopedic implant based on substantial equivalence and successful non-clinical testing, not on the performance metrics typically associated with AI or diagnostic device studies.

Summary

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K 014/34 pg19/

510(k) Summary

Date December 13, 2002

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121-2700

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-4694

Common name

Press-fit hip stem

Classification name

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented (per 21 CFR section )

Equivalent Device

SL-PLUS Stem cleared on K001942.

Device Description

This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.

Intended Use

The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Summary of Technological Characteristics Compared to Predicate Device

The UNI Stem is similar to the SL-PLUS Stem. Both stems have the same overall stem profile and are manufactured from similar titanium alloys (Ti6Al4V - UNI Stem & Ti6Al7Nb - SL-PLUS Stem). The indications for use are the same for both stems. The only difference are the minor change in material, removal of lateral suture holes from the SL-PLUS stem, and slightly smaller cross section and head offset for the Uni stem.

Summary Nonclinical Tests

Fatigue testing per ISO 7206-4 was successfully performed.

JAN 1 5 2003

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

PLUS Orthopedics C/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681

Re: K024134 Trade/Device Name: UNI Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LWJ, JDI Dated: December 13, 2002 Received: December 16, 2002

Dear Mr. Webb:

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. J. D. Webb

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 A. Millman

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):_____________________________________________________________________________________________________________________________________________________

K 024134

Device Name: UNI Hip Stem

Indications for Use:

UNI Hip Stem Indications for Use

Mark N Milkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices 024134 510(k) Number_

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.