The indications for use of the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica Osteonics acetabular component systems, are as follows:

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

Device Description

The Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, when used with the commercially available Trident® UHMWPE Acetabular Insert, is an artificial total hip replacement device which consists of an acetabular shell and a mating insert. Each insert/shell assembly is intended to resurface the acetabulum thereby providing a suitable articulating surface for a mating artificial stem/head combination.

The Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating is manufactured from ASTM F-136 Ti6Al-4V ELI alloy, and employs a porous coating fabricated from ASTM F-67 Commercially Pure (CP) Titanium. Overlaying the porous coating is a 20 micron thick layer of Peri-Apatite™ coating.

The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ Coating are characterized by the following features:

The outer shell has a single radius (hemispherical) geometry
A shell substrate composed of titanium alloy (Ti6Al-4V ELI) comparable to that used in other Howmedica Osteonics acetabular components
A titanium porous coating (CP Titanium) which meets the definition of porous coating outlined in 21 CFR 888.3358, and is comparable to that used in other Howmedica Osteonics hip and knee components
Peri-Apatite™ coating that is used on the Vitalock® Solid Back Shell with Peri-Apatite™ coating.
An interior geometry which allows a mating with the Trident® UHMWPE inserts through maximum conformity and a wireless locking mechanism.
Availability with screw hole options and cluster screw holes which accept Osteonics® 5.5mm and 6.5mm Cancellous bone Screws (K873251, K894124). A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs (K942809). The Osteonics® 5.0mm Cancellous Screws are available for use with peripheral screw holes.
A range of outer diameters from 40 through 82mm in 2mm increments.
The following shell configurations will be available:
- dome hole only, no screw holes
- 2-3 cluster screw holes, and dome hole
- 3-5 cluster screw holes and dome hole
- 5 cluster screw holes with 4 inferior screw holes, and dome hole
- 8-12 multiple dome screw holes and dome hole
- 5-7 peripheral screw holes and dome hole

AI/ML Overview

Here's an analysis of the provided text regarding the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating, focusing on the acceptance criteria and the study that proves the device meets them.

Disclaimer: This 510(k) summary is for a medical device submitted in 2001. The criteria, methodologies, and regulatory landscape for medical device approval have significantly evolved since then. The information presented here reflects the document's content and not necessarily current best practices or regulatory requirements.

The provided document is a 510(k) Summary for the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. A 510(k) submission is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing the new device's technological characteristics and proposed indications for use to those of existing predicate devices, rather than comprehensive clinical studies to establish independent acceptance criteria and direct performance metrics in the way a PMA (Premarket Approval) would.

Therefore, the concept of "acceptance criteria" in this context refers to demonstrating that the new device is as safe and effective as the predicate device(s) through comparison of materials, design, indications, contraindications, and performance testing where relevant (e.g., sterilization, biocompatibility, mechanical testing – though specific details of these tests are often summarized rather than fully detailed in the 510(k) summary).

There is no explicit table of discrete acceptance criteria with numerical targets and reported device performance presented in this 510(k) summary. The "study" that proves the device meets the acceptance criteria is primarily the comparative analysis to the predicate devices, supported by characterization of the unique features (like the Peri-Apatite™ coating).

Analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a formal table is not present in the 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices. The document implies performance through:

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit/Derived)
Material Composition	Device manufactured from ASTM F-136 Ti6Al-4V ELI alloy and ASTM F-67 Commercially Pure (CP) Titanium, comparable to other Howmedica Osteonics acetabular components.
Porous Coating Structure	Meets the definition of porous coating outlined in 21 CFR 888.3358, comparable to other Howmedica Osteonics hip and knee components.
Peri-Apatite™ Coating	Characterized using "Calcium Phosphate [Ca-P] Coating Draft Guidance for Preparation of FDA submissions for Orthopedic and Dental Endosseous Implants." (Specific numerical performance not detailed in this summary). Used on the Vitalock® Solid Back Shell with Peri-Apatite™ coating (a predicate).
Geometric Compatibility	Single radius (hemispherical) geometry, allows mating with Trident® UHMWPE inserts through maximum conformity and wireless locking mechanism.
Screw Hole Options	Available with various screw hole configurations compatible with Osteonics® 5.5mm, 6.5mm, and 5.0mm Cancellous Bone Screws and Acetabular Dome Hole Plugs.
Size Range	Outer diameters from 40 through 82mm in 2mm increments.
Indications for Use	Identical to other legally marketed Howmedica Osteonics acetabular component systems (e.g., painful disabling joint disease, revision surgery, poor bone stock).
Contraindications	Identical to other Howmedica Osteonics hip replacement acetabular component systems (e.g., infection, neuromuscular disorder, bone stock compromise, skeletal immaturity, obesity).

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

The document does not specify a "test set" in the context of clinical data or human subject testing for this 510(k) submission. The "test set" here would refer to the technical data and comparisons made to demonstrate substantial equivalence.

Sample Size: Not applicable in the context of clinical test sets. The "sample" is material and design specifications, and the comparison against predicate devices.
Data Provenance: Not applicable in the context of patient data. The provenance is internal company data for material characterization and engineering specifications, compared against regulatory standards and predicate device information.

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

This information is not provided in the 510(k) summary. For a 510(k) submission based on substantial equivalence, the "ground truth" is largely established by existing regulatory standards, predicate device performance, and the expertise of the manufacturing team in design controls and testing protocols. No external expert panel for ground truth establishment for a test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human test set 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 device is a hip implant, not an imaging or AI diagnostic tool. MRMC studies are irrelevant to this product's approval pathway as described here.

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

Not applicable. This device is a hip implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is based on:

Predicate Device Equivalence: The primary ground truth is the safety and effectiveness of the legally marketed predicate devices (Trident® Porous Titanium Acetabular Component K010170 and Vitalock® Solid Back Shell with Peri-Apatite™ Coating K971206).
Regulatory Standards: Compliance with relevant ASTM material standards (F-136, F-67) and FDA regulations (21 CFR 888.3358 for porous coating, "Calcium Phosphate [Ca-P] Coating Draft Guidance").
Engineering and Material Characterization: Internal testing and analysis demonstrating the device's material properties, geometric conformity, and coating characteristics meet established specifications and are comparable to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set" in the context of this submission.

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

Not applicable, as there is no training set for this type of device.

Summary

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DEC 2 0 2001

(013475

510(k) Summary

Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating

The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ Coating described in this 510(k) submission consist of single use devices which are intended for cementless fixation within the prepared acetabulum. The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ coating are intended for mating with the commercially available Trident® UHMWPE Acetabular Inserts (N2Vac packaged and Crossfire™ styles), also single use devices.

If supplemental bone screw fixation is deemed necessary, Osteonics® 5.5mm and 6.5mm Cancellous Bone Screws (K894124, K873251) can be placed through the shells' dome screw holes without interfering with the seating of the insert.

The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ Coating are compatible with any appropriately selected, legally marketed Howmedica Osteonics hip stem/head combination.

Indications:

The indications for use of the Trident® Porous Titanium Acetabular Shell with Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica Osteonics acetabular component systems, are as follows:

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

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NOLLS

Contraindications:

As with other Howmedica Osteonics hip replacement acetabular component systems, the contraindications for the Trident® Porous Titanium Acetabular Component with Peri-ApatiteTM Coating include:

Any active or suspected latent infection in or about the hip joint. .
Any mental or neuromuscular disorder which would create an unacceptable risk ● of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
Bone stock compromised by disease, infection, or prior implantation which . cannot provide adequate support and fixation of the prosthesis.
Skeletal immaturity. .
Obesity. An overweight or obese patient can produce loads on the prosthesis . which can lead to failure of the fixation of the device or to failure of the device itself.

Device Description

The Trident® Porous Titanium Acetabular Shells with Peri-Apatite™ Coating are characterized by the following features:

The outer shell has a single radius (hemispherical) geometry .
A shell substrate composed of titanium alloy (Ti6Al-4V ELI) comparable to that . used in other Howmedica Osteonics acetabular components

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A titanium porous coating (CP Titanium) which meets the definition of porous ● coating outlined in 21 CFR 888.3358, and is comparable to that used in other Howmedica Osteonics hip and knee components
Peri-Apatite™ coating that is used on the Vitalock® Solid Back Shell with Peri-. Apatite™ coating.
An interior geometry which allows a mating with the Trident® UHMWPE inserts . through maximum conformity and a wireless locking mechanism.
Availability with screw hole options and cluster screw holes which accept . Osteonics® 5.5mm and 6.5mm Cancellous bone Screws (K873251, K894124). A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs (K942809). The Osteonics® 5.0mm Cancellous Screws are available for use with peripheral screw holes.
A range of outer diameters from 40 through 82mm in 2mm increments. .
The following shell configurations will be available: .
- dome hole only, no screw holes ﺖ
- 2-3 cluster screw holes, and dome hole ・
- 3-5 cluster screw holes and dome hole -
- 5 cluster screw holes with 4 inferior screw holes, and dome hole -
- 8-12 multiple dome screw holes and dome hole -
- 5-7 peripheral screw holes and dome hole ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Characterization of the Peri-Apatite™ coating was presented to the extent possible using the testing outlined in the FDA document "Calcium Phosphate [Ca-P] Coating Draft Guidance for Preparation of FDA submissions for Orthopedic and Dental Endosseous Implants."

The Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating is substantially equivalent to other legally marketed devices. These products are listed below:

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510(k) Summary

Trident® Porous Titanium Acetabular Comp with Peri-Apatite™ Coating

Trident® Porous Titanium Acetabular Component K010170 1) Howmedica Osteonics Corp.
Vitalock® Solid Back Shell with Peri-Apatite™ Coating K971206 2)

A discussion of the equivalent features was presented.

For further information please contact:

Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401 (201) 934-4359

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K013475 Trade Name: Trident™ Porous Titanium Acetabular Component w/Peri-Apatite Regulation Number: 888.3358 Regulation Name: Prothesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, non-porous, Calcium Regulatory Class: II; unclassified Product Code: LPH; MEH Dated: October 18, 2001 Received: October 19, 2001

Dear Ms.Crowe:

We have reviewed your Section 510(k) premarket 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) 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. Margaret Crowe

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotel with a motification. The FDA finding of substantial equivalence of your device to a legally premarket notication. "The 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 additionally 21 011 594-4659. Additionally, for questions on the promotion and advertising of Compinates at (301) 594 - the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Celia M. Witten, Ph.D., M.D.

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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K0013475
page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating

Indications for Use:

The indications for use of the Trident® Porous Titanium Acetabular Component with

Peri-Apatite™ Coating, in keeping with those of other legally marketed Howmedica

Osteonics acetabular component systems, are as follows:

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

Prescription Use X OR (per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Signature

(Division Sign-Off) (Division Sign Cral, Restorative Division ological Devices

510(k) Number K013475

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.