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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful 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.
When used with MDM Liners:
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner:
The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Tritanium Acetabular Shells are indicated for cementless use only.

The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments.
The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology.
There are three designs of Trident® II Tritanium® Acetabular Shells:
Solidback (sizes 42A-66H)
Clusterhole (sizes 42A-66H)
Multihole (sizes 42A-72J)
The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.

The provided document is a 510(k) premarket notification for a medical device called "Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document as it pertains to AI/ML device validation, which is not the subject of this 510(k) submission.

However, I can extract the following relevant information based on the typical requirements for a 510(k) submission for a non-AI/ML device:

1. Acceptance Criteria and Reported Device Performance:
   The document states that "performance testing show that the Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screw are substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles." This implies that the acceptance criteria are met if the device's performance is comparable to the predicate devices. The performance is assessed through various non-clinical laboratory tests.

   Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (Summary)
   Mechanical strength and fixation (e.g., push-out, lever-out, torque-out, fatigue, plastic deformation)	Device demonstrated acceptable performance in all listed non-clinical tests (e.g., Push out (ASTM F1820), Lever out (ASTM F1820), Torque out (ASTM F1820), Fatigue, Plastic Deformation) ensuring substantial equivalence to predicate.
   Bone screw performance	Demonstrated acceptable performance based on Bone Screw Testing (ASTM F543).
   Porous surface characteristics	Porous surface meets requirements outlined in FDA guidance documents ("Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement").
   Biocompatibility / Pyrogenicity	Achieved acceptable endotoxin limit as specified in ANSI/AAMI ST72:2011 via Bacterial endotoxin testing (BET).
   Range of Motion	Acceptable Range of Motion Analysis was performed.
   Fretting Evaluation (for MDM liner)	Acceptable Fretting Evaluation of the MDM liner was performed.
   Material Chemistry	Acceptable Material Chemistry evaluations were performed.

2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The tests are laboratory-based, often using a small number of physical samples (e.g., implants, screws) for mechanical testing to destruction or specific load cycles.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is typically established through adherence to standardized test methods (e.g., ASTM standards) and material science principles, interpreted by engineers and material scientists.

4. Adjudication method for the test set: Not applicable. Performance data from laboratory tests do not involve human adjudication in the way clinical or image-based studies do.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a physical medical implant, not an AI/ML diagnostic or assistive device.

6. If a standalone performance study was done: The non-clinical laboratory testing represents the standalone performance evaluation of the device's physical and mechanical properties.

7. The type of ground truth used: The "ground truth" for this device's performance is defined by established engineering and materials science principles, standard test methodologies (e.g., ASTM standards), and regulatory guidance documents for orthopedic implants. For example, for mechanical strength tests, the ground truth is often a failure point or a resistance level under specific applied loads. For biocompatibility/pyrogenicity, it's the defined acceptable endotoxin limit.

8. The sample size for the training set: Not applicable. This device is not an AI/ML product developed using a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document is for a traditional medical device (hip implant) and therefore lacks the detailed information typically requested for AI/ML device validation studies. The "study" mentioned here refers to the battery of non-clinical laboratory tests performed to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

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The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A.® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty.

The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in comented primary or revision total hip arthroplasty.

The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K951114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary of revision total hip arthroplasty.

SEE ADDITIONAL PAGE LABELED DURATION WEAR CLAIMS

Duration™ Stabilized UHMWPE - Hip Components

The provided document describes wear claims for Howmedica's Duration™ Stabilized UHMWPE hip components and does not present acceptance criteria or a study design in the typical format for medical device performance evaluation against specific metrics like sensitivity, specificity, or accuracy. Instead, it describes a series of in vitro wear simulation tests demonstrating a reduction in volumetric wear compared to conventionally gamma-sterilized components.

Therefore, the requested information cannot be fully provided as it pertains to a different type of performance evaluation (e.g., diagnostic accuracy of an AI device vs. material wear properties of an implant). However, I can extract and structure the information presented regarding the wear tests.

Here's an attempt to structure the available information, noting where specific requested fields are not applicable or estimable from the provided text:

Acceptance Criteria and Device Performance (Wear Claims)

Given the nature of the document detailing material wear claims, the "acceptance criteria" are implicitly a demonstrable reduction in volumetric wear compared to the conventionally sterilized counterpart. The reported device performance is the percentage reduction in volumetric wear.

Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms." This is a crucial disclaimer for interpreting these results.

Study Details (as inferrable from the provided text):

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of hip components (samples) used in each test (e.g., N=3 per group). It refers to "a hemispherical cup" or "neutral acetabular inserts," implying at least one test article for each condition, but standard practice usually involves multiple samples for statistical validity.
   • Data Provenance: The data is from in vitro laboratory tests. The document mentions "Howmedica's" tests and an "independent laboratory test." This indicates the data is from manufacturer-sponsored and potentially third-party laboratory experiments, not from human patients or clinical trials.
   • Retrospective or Prospective: These are prospective laboratory experiments designed to assess wear characteristics under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For material wear testing, "ground truth" is typically established by direct measurement of material loss (e.g., gravimetric or profilometric methods) in a controlled laboratory setting, not by expert consensus or interpretation in the way one would assess clinical images or outcomes. The "ground truth" here is the measured volumetric wear.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or experts, which is not relevant to automated laboratory measurements of material wear.

4. 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 document describes in vitro mechanical testing of a medical implant material, not a study involving human readers or AI assistance.

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

   • Not Applicable. This is not an algorithm-based device. It's a physical implant, and the assessment is of its material properties in a simulator.

6. The type of ground truth used:

   • The "ground truth" for these tests is the direct, quantifiable measurement of volumetric wear of the UHMWPE components under simulated physiological loading conditions. This is obtained through laboratory techniques (e.g., gravimetric analysis and density measurements to calculate volume loss).

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI context where "training sets" are used. The material properties are inherent to the manufactured product, and performance is tested directly.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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