The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Device Description

The Trident® Constrained Acetabular Insert is a specific insert designed to accept a Stryker UHR® bipolar head. The bipolar head is preassembled to the insert and securely retained by a titanium alloy retaining ring. This submission details two separate modifications to the predicate Trident Constrained Acetabular Insert. The first modification is described as the subject Trident® 0° Constrained Acetabular Insert. The subject Trident® 0° Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Constrained Acetabular Insert. The second modification is described as the subject Trident® All-Poly Constrained Acetabular Insert. The subject Trident® All-Poly Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Constrained Acetabular Insert and a modified external geometry to allow for cement fixation.

AI/ML Overview

This is a 510(k) summary for a medical device, specifically a line extension to an existing acetabular insert. It does not contain information about studies involving expert consensus, human readers, or AI. The assessment for this device is based on "substantial equivalence" to predicate devices, which is demonstrated through mechanical testing and analysis rather than clinical trials with human subjects.

Therefore, many of the requested categories are not applicable to the provided document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a tabled format for performance. Instead, it states that "Mechanical testing and analysis demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength." This implies that the performance (mechanical strength) of the new components met the implicit criteria for substantial equivalence to the predicate devices.

Acceptance Criteria	Reported Device Performance
Mechanical Strength equivalent to predicate devices	Substantial equivalence demonstrated through mechanical testing and analysis.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for mechanical testing. It mentions "mechanical testing and analysis," which typically involves a set number of physical samples, but the exact number is not provided. The data provenance is not specified beyond being part of the submission to the FDA. It's almost certainly laboratory-based testing, not clinical data, and therefore not retrospective or prospective in the usual clinical sense.

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. The assessment is based on mechanical testing of the device itself, not on interpretation of data by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical ground truth requiring adjudication.

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 not a study involving human readers or AI.

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

Not applicable. This is not a study of an algorithm.

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

The "ground truth" for this submission is based on mechanical strength as determined by engineering tests, and a comparison to the mechanical strength of legally marketed predicate devices. There is no clinical or pathological "ground truth" involved in this type of submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable.

Summary

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Line Extension to the Trident Constrained Acetabular Insert

K06165 1 of 2)

Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Trident® Constrained Acetabular Insert

JUL - 7 2006

Proprietary Name:	Trident® Constrained Acetabular Insert
Common Name:	Constrained Hip Prosthesis
Proposed Regulatory Class:	Class II
Classification:	21 CFR § 888.3310 - Prosthesis, Hip, Constrained, Cemented or
	Uncemented, Metal/ Polymer
Device Product Code:	87 KWZ
For Information contact:	Joseph Viola
	Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, NJ 07430
	Telephone: (201) 831-5379
	Fax: (201) 831-6038

Email: joseph.viola@stryker.com

May 15, 2006 Date Summary Prepared:

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Special 510(k) Premarket Notification

Device Description

Indications for Use

Substantial Equivalence

The features of the subject components are substantially equivalent to the predicate devices, the Trident® 10° Constrained Acetabular Insert (P960047), the Howmedica Osteonics Contemporary Cup (K982670) and the Biomet Freedom™ Constrained Acetabular Insert (K030047), based on similarities in intended use, materials and design. Mechanical testing and analysis demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate Trident® insert and subject components are identical.

ﻟﺪ

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Howmedica Osteonics Corp. c/o Mr. Joseph Viola Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K061654 Trade/Device Name: Trident® Constrained Acetabular Insert Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: May 15, 2006 Received: June 13, 2006

Dear Mr. Viola:

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 for associoior 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 r ou may , atests 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 – Mr. Joseph Viola

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/industry/support/index.html.

Sincerely yours,

Вашазе Вневно

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K061654 510(k) Number (if known):

Device Name: Trident® Constrained Acetabular Insert

Indications For Use:

The Trident® Constrained Acetabular Insert is intended for use as a component of a total . hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Prescription Use

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amlan Bhund

AND/OR

Restorativ Division of Gene and Neurological Devices

510(k) Number K061654

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”