This device is indicated 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 function 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.

Device Description

The PERFECTA® RS Lateralized Hip Stem is manufactured from titanium alloy (ASTM F 136). The stem is designed to provide an increased offset during total joint replacement. The stem is available in standard lengths and features a collared and collarless version. The stem has a plasma spray coating on the posterior portion of the stem. The distal portion of the stem features a coronal slot and distal flutes. The stem is designed for press-fit applications.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PERFECTA® RS Lateralized Hip Stem:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meets requirements cited in FDA Guidance Documents.	"Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents."
Substantially equivalent to predicate devices.	"The PERFECTA® RS Lateralized Hip Stem was declared substantially equivalent to the predicate devices." (Predicate devices listed as Dual Offset PERFECTA® IMC Hip Stem and BRIDGE® Hip System).
Indicated for specific conditions in total hip arthroplasty (THA).	The device is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with: - Non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia) - Inflammatory degenerative joint disease (e.g., rheumatoid arthritis) - Correction of function deformity - Revision procedures where other treatments or devices have failed - Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Performance demonstrated through "Mechanical test data"	The text explicitly states "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents." This implies the performance criteria were related to the mechanical properties and integrity of the hip stem for its intended use. However, the specific numerical or qualitative acceptance thresholds for these mechanical tests are not detailed in the provided summary.

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

The provided summary does not specify the sample size used for any test set nor does it mention the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Mechanical test data" but provides no details on the number of samples tested.

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

This information is not provided in the document. The evaluation of the device's performance relies on "Mechanical test data," which typically does not involve human experts establishing ground truth in the same way clinical imaging or diagnostic AI studies would.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the evaluation is based on "mechanical test data" rather than expert interpretation of clinical cases, there wouldn't be an adjudication method in the context described (e.g., 2+1 radiologist review).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on mechanical testing for substantial equivalence, not on comparing performance with or without AI assistance for human readers.

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

No, a standalone study in the context of an algorithm's performance was not done. This document is about a medical device (hip stem), not an algorithm or AI system. The "stand-alone" evaluation refers to the device's mechanical properties.

7. The Type of Ground Truth Used

The ground truth used was based on benchmarked mechanical properties/performance standards as outlined in FDA Guidance Documents. The "mechanical test data" for the device was compared against these established standards to determine if it "meets the requirements." This is analogous to engineering specifications rather than clinical outcomes, pathology, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This information is not applicable/provided. The PERFECTA® RS Lateralized Hip Stem is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" in this context would be the design, manufacturing, and preclinical testing phases, but not a data-driven training set.

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

This information is not applicable/provided for the reasons stated in point 8. The "ground truth" for the device's design and manufacturing would be engineering specifications, material properties, and established biomechanical principles, which are inherent to the product development process, not a "training set."

Summary

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991123

JUN lood

Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name is the address "5677 Airline Road, Arlington, TN 38002" and the phone number "901-867-9971".

Attachment 9

Abbreviated 510(k) Summary

Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: March 31, 1999 Trade Name: PERFECTA® RS Lateralized Hip Stem Common Name: Femoral Hip Stem Predicate Device: Dual Offset PERFECTA® IMC Hip Stem BRIDGE® Hip System

Description/Intended Use: The PERFECTA® RS Lateralized Hip Stem is manufactured from titanium alloy (ASTM F 136). The stem is designed to provide an increased offset during total joint replacement. The stem is available in standard lengths and features a collared and collarless version. The stem has a plasma spray coating on the posterior portion of the stem. The distal portion of the stem features a coronal slot and distal flutes. The stem is designed for press-fit applications.

This device is indicated 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 function 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 PERFECTA® RS Lateralized Hip Stem was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The profiles are rendered in black and are positioned to the right of the department's name, which is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN ।

Ms. Lynne Witkowski Requlatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road 38002 Arlington, Tennessee

Re: K991123 PERFECTA® RS Lateralized Hip Stem Trade Name: Requlatory Class: II Product Codes: LPH and JDI Dated: March 31, 1999 Received: April 2, 1999

Dear Ms. Witkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lynne Witkowski

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KGSII23

Attachment 3	Indications for Use Statement
510(k) Number (if known)
Device Name	PERFECTA RS Lateralized Hip Stem
Indications for Use	This device is indicated 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 function deformity;Revision procedures where other treatments or devices have failed; andTreatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (per 21 CFR 801.109)

Over-The Counter Use

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(Division Sign Off) (Division of General Rastorative Devices 1991123 510(k) Number

000026

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.