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The DePuy Universal Gription™ TF Cones are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Gription TF Acetabular Augment System is intended to provide the orthopaedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The DePuy Universal Gription™ TF Cones are intended for use with the P.F.C. @ Modular Knee. P.F.C. @ Sigma® Knee, Sigma® TC3 Revision Knee, and S-ROM® Tibial Tray in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The porous Gription TF titanium cone is affixed to the mating tibial or femoral component using bone cement. After attachment, the cones are intended for fixation as an assembled construct into either the proximal tibia or distal femur, with or without bone cement.

The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use with the Pinnacle® Acetabular Cup System, the Pinnacle® Bantam Acetabular Cup System and the Pinnacle® Revision Acetabular Cup System for total hip replacement in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis.

The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled augment/acetabular cup construct is intended for cemented or cementless use.

The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

KNEE: The DePuy Universal Gription TF Cone component is manufactured from Commercially Pure (CP) Titanium Powder conforming to ASTM Specification F-1580. The Gription TF Cone is an optional component intended to provide improved fit of the femoral or tibial prosthesis where the metaphyseal bone in the distal femur or proximal tibia is either absent or of poor quality. The Gription TF Cone component consists of a conical CP Titanium porous structure with a general cone shaped geometry tapering from the surface nearest the joint line to a smaller dimension internal to the metaphysis. The hollow cone shape made of this porous material provides a porous structure to interface with the native bone and an internal geometry that allows for cement adhesion between the cone and the mating implant (either tibial or femoral component). The Gription TF Cone component is affixed to the mating tibial base or femoral component using bone cement. The cones are intended for fixation as an assembled construct in either the proximal tibia or distal femur, with or without bone cement, in cases of severe bone loss.

There are eight component sizes: 45x15, 53x15, 53 mm stepped LT, 53 mm stepped RT, 61x15, 61x30, 61 mm stepped LT, and 61 mm stepped RT. The larger dimension represents the widest M/L points of the cones and the second dimension represents the depth of the implant. The stepped cones will have two depth levels that are split halfway across the part; these depths are 15 and 30 mm. These stepped cones are labeled Left or Right indicating the side with the shorter 15 mm dimension. The narrow end of the cone provides an opening with a minimum dimension across of 24.5 mm to allow for DePuy stems of all diameters to pass through the hole without interfering with the cone.

HIP: The DePuy Gription TF Acetabular Augment System provides an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Gription TF implants are manufactured from Commercially Pure (CP) Titanium powder conforming to ASTM Specification F-1580. The Acetabular Augment implants are used to fill an acetabular defect giving the acetabular shell support where bone is missing or inadequate. The Augment has an inside diameter designed to mate with the outside diameter of the Pinnacle Acetabular Shell system. The porous Gription TF acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical fixation. The Acetabular Augments incorporate screw holes that allow for the use of bone screws for adjunct fixation of the acetabular component to the native bone. The Acetabular Augments also incorporate a slot feature used to mechanically attach the augment to the acetabular shell with or without the use of bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or cementless use.

The Gription TF Acetabular Augments come in four thicknesses (10, 15, 20 and 30 mm), and six different outside diameters (50, 54, 58, 62, 66 and 70 mm). The 10 mm thick Augments have two holes for pin instrument placement as well as four total screw holes (2 on the flat, 2 in the ID) for adjunct fixation to the host bone. The 15, 20 and 30 mm thick augments have six total screw holes (4 on the flat, 2 in the ID) for adjunct fixation to the host bone. All augments have two screw holes on the ID of the Acetabular Augments that were designed to travel perpendicular to the other screw holes for added stability when attached to the host bone. All of the Acetabular Augments have cutouts for clearance when other screws are used in the acetabular shell. Each Augment implant has an inside diameter designed to mate with the outside diameter of the Pinnacle Acetabular Shell system. The Augment implants can be cemented to the shell, or mechanically fixated by threading a 6.5 mm Cancellous bone screw through the shell into the slot in the Augment.

The DePuy Gription TF Acetabular Buttress Augments are designed to support the acetabular shell in a manner similar to the augment implants; however, the Buttress implant spans the defect in the acetabulum. The Gription TF Acetabular Buttress is affixed to the mating acetabular cup using bone cement. The assembled porous titanium buttress/acetabular construct is intended for cemented or cementless use. The Buttress implant is fixated to the host bone by 5.5 mm tapered head locking screws, as well as 6.5 mm Cancellous bone screws using pre-drilled screw holes in the Buttress Augment implant.

The Gription TF Buttress implants come in three sizes (56, 62 and 68 mm) and three configurations (Left, Right and Neutral). Each Buttress implant has six total screw holes; two are for use with 6.5 mm Cancellous bone screws and four are for use with 5.5 mm locking or nonlocking Cancellous bone screws. Each Buttress implant has a spherical inside diameter which is designed to mate with the acetabular shell's outside diameter. The Gription TF Buttress implants were designed to have a curved, tapered top side to facilitate implanting under soft tissue.

The Gription TF Shim implants are designed to mate with the Buttress implant to raise or support the end of the Buttress when pelvic geometries are not flat. The porous Gription TF Shim is affixed to the mating Buttress using bone cement. The assembled porous titanium buttress/shim construct is intended for cementless use. The Shim implant has clearance holes for Buttress screw adjunct fixation.

The Gription TF Shim implants come in three different configurations: 5-degree and 15-degree shapes. The Shim implants have four clearance holes for the 5.5 mm tapered head locking screws coming from the Buttress implant. The Gription TF Shim implants can be oriented in any direction to fit the bony geometry of the patient.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the document does not contain the specific information requested about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

Instead, this document describes a traditional medical device (joint implants) and demonstrates its substantial equivalence to previously marketed devices through non-clinical (mechanical) testing.

Here's an analysis based on the provided text, highlighting that this type of information is generally not applicable to a 510(k) for a physical implant:

The provided document is a 510(k) Summary for the DePuy Universal Gription™ TF Cones (Knee) and DePuy Gription™ TF Acetabular Augment System (Hip). This document aims to demonstrate "substantial equivalence" to previously cleared predicate devices, rather than proving the performance of a new AI algorithm. As such, the requested information elements related to AI model evaluation (like sensitivity, specificity, AUC, human reader improvement with AI, etc.) are not present in this type of submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical mechanical and material testing conducted to show the safety and effectiveness of the physical implant components.

Here's a breakdown based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the device "met performance requirements" but does not explicitly list the quantitative acceptance criteria (e.g., "shear strength must exceed X N") or the exact numerical results obtained for each test. This level of detail is typically found in the full 510(k) submission, not the summary.

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

• Sample Size for Test Set: Not specified in the summary. For mechanical tests, this would refer to the number of components or constructs tested.
• Data Provenance: Not explicitly stated. The testing was "Non-clinical Testing," likely performed in a lab setting, presumably in the US or under conditions acceptable to the FDA. It is not patient data, so terms like "retrospective" or "prospective" are not applicable.

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. This relates to an AI or diagnostic device evaluation. For this physical implant, the "ground truth" or "reference standard" is based on established engineering principles, ASTM standards, and FDA guidance for implant testing. It's determined by the test methods themselves and material properties, not expert consensus on medical images or diagnoses.

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

• Not applicable. This refers to methods for resolving discrepancies among multiple human experts, which is not relevant for mechanical device testing.

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:

• No. This is a physical implant, not an AI diagnostic tool. Therefore, an MRMC study with human readers and AI assistance was not conducted or applicable.

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

• No. This is a physical implant, not an AI algorithm. Therefore, "standalone" performance of an algorithm is not applicable.

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

• Engineering Standards and Material Specifications: The "ground truth" for demonstrating the safety and effectiveness of this device is adherence to recognized engineering standards (e.g., ASTM F1044), FDA guidance documents for orthopedic implants, and the material specifications (e.g., Commercially Pure (CP) Titanium Powder conforming to ASTM Specification F-1580). These standards define acceptable mechanical properties and behaviors.

8. The sample size for the training set:

• Not applicable. This refers to the training of an AI model. For a physical implant, there isn't a "training set" in this sense. The design and manufacturing processes are refined based on general engineering knowledge and predicate device experience.

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

• Not applicable. As above, there's no "training set" for an AI model. The design and validation of the Gription TF implants are based on established biomechanical principles and regulatory requirements for orthopedic devices.

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