The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

Indications:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Description

The existing Trident® Acetabular System features acetabular liners in neutral, hooded and eccentric versions. The subject Trident® Elevated Rim Liners are an addition to the existing liners. They feature an elevated superior rim. The elevated rim is intended to provide added resistance to dislocation during high flexion/adduction angles. The subject liners will also be offered in five new sizes. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured according to your requested information.

It appears the provided document is a 510(k) Premarket Notification for a line extension of an artificial hip component (Trident® Elevated Rim Liners). This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance in the same way a novel device might. The "study" mentioned is primarily engineering analysis and hip wear simulator testing, not a clinical trial or AI algorithm validation.

Based on the provided text, the device is a mechanical medical device, not an AI/ML-driven diagnostic or therapeutic tool. Therefore, many of your requested items, particularly those related to AI algorithm performance (e.g., test set, ground truth, experts, MRMC studies, standalone performance), are not applicable to this submission.

Acceptance Criteria and Device Performance Study for Trident® Elevated Rim Liners

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance: Risk of cam-out is less than or equal to predicate devices.	Engineering analysis demonstrated the risk of cam-out for the subject device is less than the risk associated with predicate devices.
Biocompatibility/Durability: Comparable safety and effectiveness of thinner liners (in terms of wear characteristics) to predicate devices.	Hip wear simulator testing demonstrated comparable safety and effectiveness of the thinner liners in the subject series to the predicate devices.
Intended Use & Indications: Device meets the stated intended use and indications.	The device is intended for total hip replacement with a specific set of indications, consistent with existing devices.

Explanation: The acceptance criteria are implicit based on the comparison to predicate devices, which is fundamental to a 510(k) submission. The goal is to show the new device is "substantially equivalent" in terms of safety and effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The studies mentioned are:
- Engineering analysis: This would involve calculations, simulations, and possibly mechanical testing of a limited number of physical prototypes or CAD models. No "sample size" in the conventional sense of patient data is applicable.
- Hip wear simulator testing: This involves testing physical implants in a lab setting. The number of devices tested and the duration of testing (cycles) are not specified.
Data Provenance: Not applicable in the context of patient data. This is a pre-market submission for a physical device, based on engineering principles and laboratory testing.

3. 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. This is a mechanical device, and no "ground truth" derived from expert consensus on medical images or diagnostic outcomes is relevant to the studies described. The "ground truth" for mechanical performance is based on engineering principles, material science, and established biomechanical testing standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. As no expert review or clinical trial data is presented for adjudication, this concept does not apply.

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 is a mechanical implant device, not an AI-driven system.

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

Not Applicable. This is a mechanical implant device, not an AI algorithm.

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

The "ground truth" for the engineering analysis and hip wear simulator testing is based on:
- Engineering Principles and Biomechanical Standards: For cam-out risk, this would tie into established mechanical properties, design specifications, and relevant biomechanical forces.
- Laboratory Measurements and Material Science: For wear, this involves direct measurement of wear rates in controlled simulator environments, compared against industry standards and predicate device performance.

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."

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

Not Applicable. There is no training set for a mechanical device.

Summary regarding the provided text:

The submission focuses on demonstrating "substantial equivalence" of the new Trident® Elevated Rim Liners to existing predicate devices. This is achieved through:

Technological Comparison: Highlighting that the new liners are an addition to the existing system, using the same material (Crossfire® polyethylene), but with an elevated rim and new sizes.
Engineering Analysis: To show that the risk of "cam-out" (a mechanical disengagement issue) is improved compared to predicate devices.
Hip Wear Simulator Testing: To demonstrate that the wear characteristics of the thinner new liners are comparable to the predicate devices, thus ensuring similar safety and effectiveness in terms of durability.

The document does not detail patient-based studies or the validation of an AI/ML algorithm.

Summary

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K020497
1 OF=2

Line Extension to the Trident® Acetabular System - Trident® Elevated Rim Liners

Special 510(k) Premarket Notification

Special 510(k) Summary

Line Extension to the Trident® Acetabular System - Trident® Elevated Rim Liners

Proprietary Name:	Trident® Elevated Rim Liner
Common Name:	Artificial Hip Components
Classification Name and Reference:	Hip joint, metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 21 CFR §888.3358
Proposed Regulatory Class:	Class II
Device Product Code:	87 LPH
Predicate Proprietary Name(s):	Osteonics® Secur-Fit™ AD Generation IIAcetabular Component System; andLine Extension, Osteonics® Trident® PolyethyleneInserts
Predicate Regulatory Class:	Class II
Predicate Product Code(s):	87 LPH and LZO
For Information contact:	Nancy J. Rieder
	Howmedica Osteonics Corp.
	59 Route 17
	Allendale New Jersey 07401-1677

Description/Technological Comparison

Phone: (201) 934-4364 Fax: (201) 760-8435

Page 1

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Special 510(k) Premarket Notification

resistance to dislocation during high flexion/adduction angles. The subject liners will also be offered in five new sizes. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.

Intended Use

Indications:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femoral head replacement, cup arthroplasty or other procedure. ●
Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

Testing Summary

Engineering analysis was employed to ensure that the risk of cam-out for the subject device is less than the risk associated with predicate devices. Hip wear simulator testing of a similar cup liner was used to demonstrate the comparable safety and effectiveness of the thinner liners in the subiect series to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

MAR 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elizabeth A. Staub Vice President Quality Assurance, Regulatory Affairs and Clinical Research Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K020497

Trade/Device Name: Trident Elevated Rim Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH

Dated: February 12, 2002 Received: February 14, 2002

Dear Ms. Staub:

We have reviewed your Section 510(k) premarket notification of intent to market the device wforders forlowed your been wind 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). and Coometer for ( 10) the 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. Elizabeth Staub

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 and additionally 21 CFR Part 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 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.

to Mark A. Millerson

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): KO204977

Device Name: Line Extension to the Trident® Acetabular System-Trident® Elevated Rim Liners

Indications:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post-traumatic arthritis, or late stage avascular necrosis.
arminis, post-tradinatio artists, or twad replacement, cup arthroplasty or other procedure. .
revision of provisions imited issues where arthrodesis or alternative reconstructive techniques are less . likely to achieve satisfactory results.
Inkery to demove stickly of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Mullaney

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

510(k) Number -

K020497

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.