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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 Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge.
The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.
The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

This document is a 510(k) premarket notification for the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device.

Based on the provided text, the device in question is a medical implant (an intervertebral body fusion device), not an AI/ML-enabled medical device that would typically undergo the kind of performance studies and establish acceptance criteria outlined in your request. The document discusses mechanical properties, material, and manufacturing processes, but it does not mention any AI algorithms or software components.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in this specific document, as those types of studies are not relevant for this kind of physical medical device.

In summary, this document does not contain the information needed to answer your questions because it pertains to a traditional physical medical device, not an AI/ML-enabled medical device.

Ask a specific question about this device