(442 days)
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:
- Painful, disabling joint disease of the hip resulting from: non-inflammatory . 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided text describes the 510(k) premarket notification for the Trident® Hip System and its polyethylene inserts. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/software-as-a-medical-device (SaMD) clearances.
This document is for a physical medical device (a hip replacement system), not an AI/software device. Therefore, the questions related to AI performance metrics, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The "Summary of Safety and Effectiveness" section (page 1) broadly outlines data presented to demonstrate equivalence to predicate devices, but this is about the physical properties and performance of the hip implant itself, not an AI's diagnostic or predictive capabilities.
Here's an attempt to answer the questions based on the available information, noting the differences between a physical device clearance and an AI/SaMD clearance:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., sensitivity, specificity, AUC). Instead, it refers to demonstrating "equivalence of the proposed products to the predicate devices" through various tests for a physical medical device.
| Acceptance Criteria (Implied for a physical device) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate devices in material properties. | Material properties testing performed. |
| Equivalence to predicate devices in wear characteristics. | Wear testing performed. |
| Sterilization process effectiveness and material integrity post-sterilization. | Effect of STERRAD gas plasma sterilization on the sequentially crosslinked and annealed material assessed. |
| Dimensional accuracy and fit with mating components. | Dimensional assessment of the sequentially crosslinked and annealed material performed. |
| Mechanical stability and assembly integrity (e.g., resistance to disassembly). | Disassembly force evaluation performed. |
| Appropriate contact stresses during use. | Contact stresses evaluated. |
| Meeting established standards for hip implants (implied by predicate comparison). | A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of patient numbers or specific clinical study sizes, as this is a materials/mechanical performance submission for a physical device. The "test set" would refer to batches of manufactured components or materials samples used in laboratory testing.
- Data Provenance: Not specified. The testing described (material properties, wear, sterilization effects, dimensions, disassembly force, contact stresses) sounds like laboratory-based engineering and bench testing, rather than human clinical trial data.
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)
This concept is not applicable to this 510(k) submission. "Ground truth" in the context of this device refers to the physical and mechanical properties of the hip implant itself, verified through laboratory measurements and engineering principles, not expert interpretation of outputs from an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/SaMD submission requiring expert adjudication of outputs.
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 physical medical device. MRMC studies are relevant to AI/SaMD for diagnostic or assistive purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component mentioned in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for the performance claims would be established through:
- Engineering specifications and design requirements.
- Laboratory measurements of material properties (e.g., tensile strength, fatigue life).
- Bench testing results for wear, dimensional accuracy, disassembly forces, and contact stresses.
- Comparison to the known properties and performance of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no AI model or "training set" for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or "training set" for this physical device.
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K033716 FEB 1 0 2005
Summary of Safety and Effectiveness
| Contact Person: | Karen AriemmaRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-5718 (Phone)(201) 831-6038 (FAX) |
|---|---|
| Date: | February 3, 2005 |
| Device: | Trident® Hip System |
| Classification: | Prosthesis Hip, Semi-Constrained, Porous Coated,Uncemented Prosthesis: 21 CFR 888.3358 |
| Hip Joint Metal/Ceramic/Polymer Semi-constrainedcemented or nonporous uncemented prosthesis: 21 CFR888.3353 | |
| Hip Joint Metal/Polymer Semi-Constrained CementedProsthesis, 21 CFR 888.3350 | |
| Device Product Codes: | 87 JDI, 87 LPH, 87 LWJ, 87 LZO, 87 MEH: |
| Predicate Devices: | Trident® Hip System |
| Indications for Use: | The Trident® Acetabular Hip System Polyethylene insertsare intended for use with the mating Trident AcetabularShells. The Trident Acetabular Shells are intended forcementless fixation. The Trident® Hip System componentsare for use in total hip arthroplasty to relieve pain andrestore function for indications such as: painful, disablingjoint disease of the hip resulting from: non-inflammatorydegenerative arthritis, rheumatoid arthritis, post-traumaticarthritis, or late stage avascular necrosis; revision ofprevious failed femoral head replacement, cup arthroplastyor other procedure; clinical management problems wherearthrodesis or alternative reconstructive techniques are lesslikely to achieve satisfactory results, where bone stock is ofpoor quality or inadequate for other reconstructivetechniques as indicated by deficiencies of the acetabulum. |
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| Proposed Modification: | Addition of new polyethylene components of a modifiedsequentially crosslinked and annealed material which hasundergone a STERRAD gas plasma sterilization. |
|---|---|
| Device Description: | The device includes the acetabular inserts of a total hipsystem. These components are used for the replacement ofthe bearing surface of the acetabulum to relieve pain,instability and the restriction of motion due to degenerativebone disease, including osteoarthritis, rheumatoid arthritis,failure of other devices or trauma. |
| Summary of Data: | A risk analysis and research and development testing havebeen performed to demonstrate equivalence of the proposedproducts to the predicate devices. The testing includesmaterial properties testing; wear testing; the effect ofsterilization on the sequentially crosslinked and annealedmaterial; dimensional assessment of the sequentiallycrosslinked and annealed material; disassembly forceevaluation; and contact stresses. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2005
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K033716
Trade/Device Name: Trident® Hip System Trade/Device Name: "Thuene" Thp 3558:21 CFR 888.3353 and 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiancetrained cemented or nonporous uncemented prosthesis,Hip joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Code: LPH, LZO, JDI, MEH and LWJ Dated: December 14, 2004 Received: December 15, 2004
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreases in the enactment date of the Medical Device Amendments, or to commerce prior to rias 2011-12-11 in accordance with the provisions of the Federal Food, Drug, devices mark nave occh recident a newee 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, mereleve, mains of the Act include requirements for annual registration, listing of general voltrols pro reserving 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 If your device is olassinod (600 a00 10) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that i Dr brisean that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must
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Page 2 - Ms. Karen Ariemma
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 CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This icter with anow you to ough mailing of substantial equivalence of your device to a legally premarket notification. The FDA mianing of castion 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 advice for Jour do 100-276-0120. Also, please note the regulation entitled, Connact the Office of Collier of Colliention" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours
Martin M. Wilkerson
Celia 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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Indications for Use
510(k) Number (if known): K033716
Device Name: Trident Hip System - Polyethylene Inserts
Indications For Use:
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:
- Painful, disabling joint disease of the hip resulting from: non-inflammatory . 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 inadequate for other reconstructive � techniques as indicated by deficiencies of the acetabulum.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
f
Concurrence of CDRH Office of Device Evaluation (ODE)
Met
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K033716
§ 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.