The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Device Description

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Equator Plus™ Acetabular Cup System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (an acetabular cup system), which primarily focuses on demonstrating substantial equivalence to predicate devices through testing and material qualification. It does not present a clinical study or performance data in the way one would for an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested fields related to clinical performance, ground truth, expert review, and AI specific metrics (like MRMC or standalone performance) will be answered as "Not Applicable" or "No information provided," as these types of studies are not relevant to the approval process described in this document for an orthopedic implant.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (demonstrated to be substantially equivalent to predicate devices)	"Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness."
Compliance to Standards	"SUMMANT of TED III. has provided analytical and mechanical testing to Portland Orthopaedics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System."
Clinical Indications for Use	Device's indications for use were reviewed and deemed acceptable by the FDA (implicitly meeting the criteria for the specified patient conditions).

Explanation: In the context of this 510(k), acceptance criteria for orthopedic implants are typically centered around demonstrating substantial equivalence to already approved predicate devices. This is achieved through:

Material compatibility and strength: Ensuring the chosen materials (titanium alloy, UHMWPE, cobalt chrome) meet industry standards and perform as expected under physiological conditions.
Mechanical performance: Testing to ensure the components (shell, liner, interface) can withstand loads and stresses encountered in the body, resist wear, and maintain structural integrity. This is often done via analytical and mechanical testing, comparing results to those of predicate devices or established standards.
Biocompatibility: Ensuring the materials are safe for implantation and do not elicit adverse biological responses.
Design validation: Confirming that the device design facilitates proper surgical implantation and long-term function.

The document states that "Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness" and that the device has "proved and compliance to standards." This is the general statement of performance proving it met the (implied) acceptance criteria for substantial equivalence. Specific quantitative performance metrics (e.g., tensile strength values, wear rates) are not provided in this summary but would have been part of the detailed testing report submitted to the FDA.

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

Sample Size: No information provided. This type of device approval relies on mechanical and analytical testing of the device itself and its components, not on a "test set" of patient data or images.
Data Provenance: No information provided for clinical data, as it was not a clinical study. Mechanical and analytical testing data would originate from laboratory settings.

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

Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnoses or image interpretations by experts, is not relevant for this type of device submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. (No clinical test set as described for an AI/algorithm device).

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

No. This is an orthopedic implant, not an AI-assisted diagnostic or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the testing described, the "ground truth" would be established engineering and material science standards and specifications (e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility, material properties of the chosen alloys and polymers). These define the expected performance thresholds and material characteristics. The device's performance against these standards constitutes its "truth" for this approval process.
No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense were used as ground truth for initial device approval, as this is a pre-market notification demonstrating substantial equivalence through physical testing, not a clinical trial proving efficacy and safety in patients.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an orthopedic implant approval. Device design and material selection are based on engineering principles and established medical knowledge, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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OCT 7 - 2005

Image /page/0/Picture/1 description: The image shows the text "510(k) Summary" in a large, bold font. The text is black and the words are underlined. The text is centered on the image.

SUBMITTED FOR:

Company Name:	Portland Orthopaedics Limited
Address:	Unit 3, 44 McCauley St
	Matraville, NSW, 2036 Australia
Telephone:	++ 61-2-9666-8444
Fax:	++61-2-9666-8544
SUBMITTED BY:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	July 5, 2005, revised September 26, 2005
TRADE NAME:	Equator Plus™ Acetabular Cup System
COMMON NAME:	Acetabular Cup System
DEVICE PROCODE & PANEL:	: JDI, LWJ, MAY Orthopaedics 87

DESCRIPTION of the DEVICE:

SUBSTANTIAL EQUIVALENCE INFORMATION

The Equator Plus™ Acetabular Cup System described in this submission is substantially equivalent to the predicate devices in the same classification and procode designation. Testing and materials qualification have demonstrated that the differences in the Equator Plus ™ Acetabular Cup System do not raise any new issues of safety and effectiveness. The Equator Plus™ Acetabular Cup System has been qualified for use with the Margron Hip Replacement System (cleared under K032641).

INDICATIONS FOR USE:

The Equator Plus™ Acetabular Cup System has the following indications for use:

· The patient should be skeletally mature.
· The patient's condition should be due to one or more of the following:
- 1. Osteoarthritis.
- 1. Rheumatoid arthritis.

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

510(k) Summary-Continued

Tumor conditions involving the upper third of the femur or of the Acetabular.

1. Ankylosing spondylitis.
1. Psoriatic arthritis.
1. I sollatie urnifitib.

Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.

1. Non union of femoral neck fracture or avascular necrosis of the femoral head.
1. Post-traumatic fracture/dislocation of the hip.
1. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
1. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
1. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

SUMMARY of TESTING:

SUMMANT of TED III. has provided analytical and mechanical testing to r orthand Orthopactics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures, representing the department's focus on health and well-being. The text is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

Portland Orthopaedics Limited c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K051844

Trade/Device Name: The Equator Plus™ Acetabular Cup System 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: MAY, JDI, LWJ Dated: September 26, 2005 Received: September 27, 2005

Dear Ms. Duncan:

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- Ms. Elaine Duncan, M.S.M.E., RAC

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark Miller

C Mark 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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Equator Plus™ Acetabular Cup System Device Name:

The Equator Plus™ Acetabular Cup System has the following indications for use:

· The patient should be skeletally mature.

· The patient's condition should be due to one or more of the following:
- 1. Osteoarthritis.
- 1. Rheumatoid arthritis.
- 1. Tumor conditions involving the upper third of the femur or of the Acetabular.
- 1. Ankylosing spondylitis.
- 1. Psoriatic arthritis.
- 1. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
- 1. Non union of femoral neck fracture or avascular necrosis of the femoral head.
- 1. Post-traumatic fracture/dislocation of the hip.

Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.

1. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
1. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use No (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)

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

510(k) Number_k o 51844

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.