The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as 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.

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

Device Description

The PROCOTYL-E Acetabular System consists of metal acetabular shells, plates and hooks.

The added design features of the PROCOTYL-E Acetabular Shell are summarized below:

The PROCOTYL-E Acetabular shell feature an oblong dual hemispherical outer geometry with a hemispherical offset to accommodate for bone loss.
Eccentricity and offset are increased to accommodate for bone loss and screw fixation.
The PROCOTYL-E shell allows use of a wide range of plates, hooks, all of which are manufactured from titanium alloy, available in various types and sizes, thus guaranteeing a stable and secure anchorage of the shell to enhanced fixation and stability.

AI/ML Overview

This K043073 submission is a 510(k) for the PROCOTYL-E Acetabular System, which is a Class II/III medical device (Hip joint metal/polymer/metal semi-constrained porous - coated uncemented prosthesis, Prosthesis, Hip, Semi-Constrained, metal/ ceramic/ polymer, cemented or non-porous uncemented, Hip joint metal/ metal semiconstrained, with uncemented acetabular component prosthesis).

Based on the provided document, there is no information about acceptance criteria or specific studies proving the device meets acceptance criteria in the context of device performance as typically described for a new or modified medical device requiring detailed efficacy or safety studies with quantitative performance metrics.

The document is a Summary of Safety and Effectiveness for a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an breakdown of the requested information based on the provided text, highlighting what is not available:

A table of acceptance criteria and the reported device performance
- Not available. The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue life, or clinical outcomes) or reported performance metrics against such criteria. The "performance" mentioned is in the context of substantial equivalence to existing devices.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document states that the "safety and effectiveness of the PROCOTYL-E Acetabular Shell are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." However, it does not specify the sample sizes or provenance of any test data. The testing mentioned refers to "materials data, and testing results," which typically implies mechanical or bench testing for orthopedic implants, not clinical trials with human subjects that would have a "test set" in the context of AI/software performance.
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/Not available. This type of information is relevant for AI/software devices where human expert annotation establishes a "ground truth" for evaluating algorithm performance. For an orthopedic implant like the PROCOTYL-E Acetabular System, the "ground truth" for its safety and effectiveness is established through different means, primarily bench testing, substantial equivalence to predicates, and potentially clinical follow-up data (though not detailed here). There's no mention of experts establishing a ground truth for a test set in the context of the device's functional integrity.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. Similar to point 3, this type of adjudication is typically used in clinical studies or for evaluating diagnostic AI algorithms where expert consensus is needed to resolve discrepancies. It is not relevant for the type of device and submission described.
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/Not available. An MRMC study is specific to diagnostic imaging devices where human readers interpret medical images. This device is an orthopedic implant, not an imaging or diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This question pertains to the performance of an algorithm or AI independently. The PROCOTYL-E Acetabular System is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied ground truth: For an orthopedic implant seeking 510(k) clearance, the "ground truth" for safety and effectiveness is generally established through:
  - Mechanical and material testing: Demonstrating compliance with industry standards (e.g., ISO for implants) for strength, fatigue, wear, biocompatibility.
  - Substantial equivalence: Comparison to a legally marketed predicate device that has established safety and effectiveness.
  - Clinical outcomes (potentially): While not explicitly detailed as a primary study in this summary, long-term clinical performance data on the predicate device or similar designs would implicitly contribute to the "ground truth" of what constitutes a safe and effective hip replacement component.
- The document mentions "materials data, and testing results," which points to mechanical/material testing as a key basis for safety and effectiveness.
The sample size for the training set
- Not applicable/Not available. "Training set" is a term used in machine learning for AI algorithms. This device is an orthopedic implant.
How the ground truth for the training set was established
- Not applicable/Not available. As above, this terminology does not apply to the PROCOTYL-E Acetabular System.

Summary of what is known from the document regarding acceptance:

The 510(k) summary states that the PROCOTYL-E Acetabular Shell is "substantially equivalent" to competitive devices previously cleared for market. This is the primary "acceptance criterion" for a 510(k) submission.
The basis for this substantial equivalence includes the intended use, material, type of interface, and design features.
The document broadly mentions "materials data, and testing results" as supporting the safety and effectiveness. This implies that the device underwent mechanical and material characterization to ensure it functions as intended and is safe for implantation, likely conforming to recognized standards for orthopedic implants. However, specific test results or quantitative acceptance criteria for those tests are not provided in this summary.
The FDA's clearance letter on May 4, 2005, signifies that the agency has accepted the manufacturer's claim of substantial equivalence, thereby allowing the device to be marketed.

In essence, this 510(k) summary focuses on demonstrating that the PROCOTYL-E Acetabular System is "just as safe and effective" as legally marketed predicate devices, rather than presenting detailed studies with specific numeric acceptance criteria and performance data for a novel device.

Summary

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

K043073

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, black letters. Below the word are three stylized, textured, arrow-like shapes pointing to the left. The arrows are arranged in a descending order, with the top arrow being the largest and the bottom arrow being the smallest. The letters "IV" are visible below the arrows.

MAY - 4 2005

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROCOTYLE-E.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

November 5, 2004

Ehab M. Esmail Senior Manager, Regulatory Affairs

PROCOTYLE-E

Acetabular Shell

21 CFR 888.3358 Hip joint metal/polymer/metal semi- constrained porous - coated uncemented prosthesis -- Class II

21 CFR 888.3353 Prosthesis, Hip, Semi-Constrained, metal/ ceramic/ polymer, cemented or non-porous uncemented- Class II

21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with uncemented acetabular component prosthesis -- Class III

Device Product Code and Panel Code:

Orthopedics/87/LPH, KWA, LZO

DEVICE INFORMATION

A. INTENDED USE

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; 3.
1. revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques.

Arlington, TN 38002 011.49.4161.745130 Germany

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

K043073 2/2

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylenc and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

B. DEVICE DESCRIPTION

The PROCOTYL-E Acetabular System consists of metal acetabular shells, plates and hooks.

The added design features of the PROCOTYL-E Acetabular Shell are summarized below:

The PROCOTYL-E Acetabular shell feature an oblong dual hemispherical outer . geometry with a hemispherical offset to accommodate for bone loss.
Eccentricity and offset are increased to accommodate for bone loss and screw fixation .
The PROCOTYL-E shell allows use of a wide range of plates, hooks, all of which are . manufactured from titanium alloy, available in various types and sizes, thus guaranteeing a stable and secure anchorage of the shell to enhanced fixation and stability.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the PROCOTYL-E Acetabular Shell are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PROCOTYL-E Acetabular Shell are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K043073

Trade/Device Name: PROCOTYL-E Acetabular System Regulation Numbers: 21 CFR 888.3330, 888.3353, 888.3358 Regulation Names: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Esmail:

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.

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

Page 2 – Mr. Ehab M. Esmail

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is issuaires or our device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must of ally redital statutes and regarations and limited to: registration and listing (21 Comply with an the rive orequentions)01); good manufacturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic form in the quality bytellio (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) I his letter will anow you to begin manesing your device of your device to a legally premits that notication. The President 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 11 you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Company of Company of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Sincerery yours,

Stpt Rlurde

riam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three stylized, overlapping shapes that resemble wings or chevrons. The "TM" symbol is located at the bottom right of the graphic.

PROCOTYL-E Acetabular System INDICATIONS STATEMENT

1043073

510(k) Number (if known):

Device Name: PROCOTYL-E Acetabular System

Indications For Use:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
correction of functional deformity; 3.
revision procedures where other treatments or devices have failed; and, 4-
treatment of fractures that are unmanageable using other techniques. న్.

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acctabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrent (Division Sign-Off)vice Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices

headquartersWright Medical Technology, Inc. 5677 Airline Road	510(k) Number	K043073
Arlington, TN 38002	901.867.9971 phone	www.wmt.com

international subsidiaries
011.32.2.378.3905 Belgium	905.826.1600 Canada	011.33.1.45.13.24.40 France	011.49.4161.745130 Germany
011.39.0250.678.227 Italy	011.81.3.3538.0474 Japan	011.44.1483.721.404 UK

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.