The PLUS Orthopedics Cemented 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 is a cemented hip stem fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799. It has a trapezoidal proximal body cross section, tapering both lateral to medial and proximal to distal. The proximal body has a cobra flange along the lateral aspect that helps to apply compressive stresses to the cement. It has a "standard 12/14" Morse type taper to accept modular heads and a neck/shaft angle of 129°. It also has a calcar collar that extends medially only.

The distal stem is conical in shape, tapering proximal to distal end the stem quickly necks down to accept a PMMA distal centralizer is four flanged and is utilized to assure that the distal stem is centered in the femoral canal and a uniform cement mantle is obtained. The distal stem bas four flutes or grooves that increases torsion stability when implanted in cement.

Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLUS Orthopedics Cemented Hip Stem:

Analysis of Acceptance Criteria and Study Design

The provided 510(k) summary for the PLUS Orthopedics Cemented Hip Stem is an application for market clearance based on substantial equivalence to predicate devices, not a clinical trial demonstrating efficacy against specific acceptance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics, sample sizes, expert involvement, and ground truth establishment) is largely absent.

Instead, the documentation focuses on:

Design Equivalence: Demonstrating that the new device is substantially equivalent in design, materials, and intended use to already legally marketed devices.
Nonclinical Testing: Primarily engineering analysis to ensure it can withstand similar loads as predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Design, Materials, Strength, and Indications Equivalent to Predicate Devices (Consensus Stem K922561, Foundation Hip K991227, Synergy stem K990369, Summit stem K013352)	"This cemented hip stem is equivalent in design, materials, strength and indications to the Consensus Stem (K922561...), the Foundation Hip (K991227...), the Synergy stem (K990369...) and the Summit stem (K013352...)"
Withstand Cyclic Loads Similar to Predicate Devices	"Engineering analysis indicates that this stem will withstand cyclic loads similar to the predicate devices."
Conform to ASTM F799 (CoCrMo alloy)	"fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799."
Aid in relieving hip pain and restoring hip motion (Intended Use)	(This is an intended use, not a performance metric directly demonstrated by this 510(k). It is implicitly accepted via equivalence to predicate devices which have established this outcome in clinical use.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and comparison to predicate devices, not a clinical test set.
Data Provenance: The engineering analysis would be conducted internally or by a contracted lab. The predicate device data is from previously cleared devices, which would have undergone their own evaluation, but no new patient data is presented here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. There was no "test set" in the sense of patient data requiring expert ground-truthing. The "truth" in this context is established by engineering principles and the known performance of predicate devices.
The "experts" involved would be the engineers and designers who conducted the analyses and compared the device to the predicate, and potentially regulatory reviewers at the FDA.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

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 device is a hip stem, a medical implant, not an imaging analysis AI or diagnostic tool.

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

Not applicable. This device is a hip stem, not an algorithm.

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

The "ground truth" for this 510(k) is primarily established regulatory clearance of predicate devices combined with standard engineering principles and material specifications (e.g., ASTM F799 for the CoCrMo alloy, and mechanical testing results that show cyclic load resistance).

8. The sample size for the training set

Not applicable. This is a hardware implant, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a medical device (hip stem) seeking clearance based on substantial equivalence. It does not contain information typically found in a study demonstrating a device meets specific performance acceptance criteria through clinical or even extensive in-vitro testing against a "ground truth" in the way an AI diagnostic device would. The core "proof" is the detailed comparison to existing, legally marketed predicate devices and confirmation of equivalent design characteristics and performance in simulated (engineering) conditions.

Summary

{0}------------------------------------------------

JUN - 6 2003 510(k) Summary

Date April 10, 2003

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock. TX 78681 212-388-0199

Common name

Cemented Hip Stem

Classification name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (per 21 CFR section 888.3350)

Equivalent Device

This cemented hip stem is equivalent in design, materials, strength and indications to the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (K991227 - Encore Orthopedics), the Synergy stem (K990369 - Smith & Nephew) and the Summit stem (K013352 - J&J/DePuy).

Device Description

Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.

Intended Use

The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural fead 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.

Summarv Nonclinical Tests

Engineering analysis indicates that this stem will withstand cyclic loads similar to the predicate devices.

Image /page/0/Picture/20 description: The image shows a sequence of alphanumeric characters, specifically 'KO31165'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or printed with a slightly rough texture. The sequence likely represents a code, identifier, or serial number.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

PLUS Orthopedics c/o Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd Round Rock, TX 78681

Re: K031165

Trade/Device Name: Plus Orthopedics Cemented Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 10, 2003 Received: April 14, 2003

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

{2}------------------------------------------------

Page 2 - J.D. Webb

forth in the quality systems (OS) 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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.

Miriam C. Provost

for 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

{3}------------------------------------------------

KOSTIFFE 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PLUS Orthopedics Cemented Hip Stem

Indications for Use:

Cemented Hip Stem Indications for Use

Miriam C Provost

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

510(k) Number K031165

p.4

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.