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This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.

The Zimmer Trabecular Metal Acetabular Revision System Cage is a device intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiencies, such as pelvic defects and discontinuities. The cage is a metallic, dome-shaped, flanged acetabular component with multiple screw holes for adjunct intraoperative peripheral stabilization of revision shell constructs. The cage is available in five sizes configured in both right and left versions along with either short or long flanges to meet various anatomical needs. It offers intraoperative flexibility of implant orientation/positioning to accommodate patient anatomies. The cage is fabricated from Commercially Pure (CP) Titanium

Here's an analysis of the provided text regarding the Zimmer Trabecular Metal™ Acetabular Revision System Cage, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is a medical implant (Acetabular Cage), and the review focuses on substantial equivalence to a predicate device rather than performance against predetermined acceptance criteria typically seen in clinical trials for diagnostic devices or new technologies.

• Non-Clinical Performance: Engineering evaluations were performed to verify that the performance of the device would be adequate for anticipated in vivo use. |
  | Safety and Effectiveness | * The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the FDA believes the device is as safe and effective as its predicate. |

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

The provided text does not describe a clinical study with a test set in the manner of a diagnostic device or a new therapeutic intervention. Instead, it refers to design verification through non-clinical engineering evaluations.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The document refers to "engineering evaluations," which would involve testing of prototypes or materials according to established standards. The sample sizes for these engineering tests are not specified.
• Data Provenance: Not applicable for a clinical test set. The "engineering evaluations" would have been conducted by the manufacturer, Zimmer, Inc.

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

This information is not applicable or provided because the review is based on substantial equivalence to a predicate device and non-clinical engineering evaluations, not a clinical study requiring ground truth established by expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable or provided as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done based on the provided text. The document explicitly states: "Clinical data and conclusions were not needed for this device."

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

This question is not applicable as the device is a physical medical implant (Acetabular Cage), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is irrelevant.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in clinical or diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. The device's safety and effectiveness were established through:

• Substantial equivalence to a legally marketed predicate device.
• Non-clinical engineering evaluations to verify performance against anticipated in vivo use. The "ground truth" for these engineering evaluations would be established engineering standards, material properties, and biomechanical principles.

8. The Sample Size for the Training Set

This information is not applicable or provided. The document details a 510(k) premarket notification for a physical medical device, not an AI or machine learning algorithm that would require a "training set."

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

This information is not applicable or provided for the same reasons as #8.

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The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use in skeletally mature individuals undergoing primary or secondary revision surgery. The device is a single use implant. The device is to be used in conjunction with any commercially available all polyethylene acetabular cup.

The Recovery Protrusio Cage is a hemispherical metallic cage. This malleable commercially pure (CP) titanium cage can be shaped by the surgeon intraoperatively to fit the proper shape of the patient's anatomy. The surface of the device has a grit blasted (roughened) finish for adherence of bone cement. The purpose of the cage is to provide reinforcement for the acetabular socket and facilitate bone grafting in cases of a severely deficient acetabulum. The pelvic bone grafts are protected from stress overload and potential collapse with the cage. This device can potential resist acetabular migration by serving as a connection between host bone to host bone. The dome of the cage contains five or six screw holes for component fixation. Two large "windows" in the dome allow for morselized bone impaction and a continuous cement mantle lateral and medial of the device. An anterior cut-out in the dome allows retroverted positioning of the cage without causing impingement of the neck and possible dislocation. A large illum flange contains six screw holes for component fixation. This flange is designed for a severely deficient acetabulum to allow engagement of the cage to host bone. An inferior obturator foramen hook is positioned beneath the "teardrop" of the ischium to provide further stability of the cage. The illum flange and the obturator foramen hook can be shaped by the surgeon to properly fit the patient's anatomy. The use of 6.5mm low profile screws placed through any (at least two) or all holes in the dome and large illum flange provide immediate stable fixation of the shell to the pelvis. Adjunctive fixation is achieved with bone cement that adheres an all polyethylene acetabular cup into the shell. The all polyethylene acetabular cup is anteverted to the correct anatomic position within the Recovery cage.

This document is a 510(k) premarket notification for a medical device (Recovery® Protrusio Cage), not a study report. It demonstrates substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance. Therefore, most of the requested information regarding study details (sample size, experts, ground truth, MRMC study, standalone performance, training set) is not available in this document.

However, I can extract the acceptance criteria for market clearance, which is demonstrating substantial equivalence, and list the comparable predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

Predicate Devices identified:

• Protek® Acetabular Roof Reinforcement Ring (Intermedics Orthopedics, Inc.) - K953578
• Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc.) - K960678
• Protrusion Cages (Depuy) - K962007
• Restoration™ GAP Acetabular Cup (Osteonics) - K943549 |
  | Intended Use: The device's intended use must be clear and comparable to predicate devices. | The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. It is for cemented application in skeletally mature individuals undergoing primary or secondary revision surgery and to be used with any commercially available all polyethylene acetabular cup. The FDA's clearance explicitly states limitations: "This device may not be labeled or promoted for non-cemented use. All labeling for this device... must prominently state that the device is intended for cemented use only." |
  | Materials and Design: Should be comparable to safe and effective predicate devices, or adequately justified. | The device is described as a hemispherical metallic cage made of malleable commercially pure (CP) titanium with a grit blasted (roughened) finish for cement adherence. This design and material selection are presented as comparable to existing acetabular cages. |
  | Risks: Potential risks associated with the device should be identified and comparable to predicate devices. | The document lists potential risks "the same as with any joint replacement device," including cement reaction, fracture of components/bone/cement, hematoma, cardiovascular/nerve/blood vessel damage, implant loosening/migration, soft tissue imbalance, excessive wear, deformity, infection, dislocation, delayed wound healing, and metal sensitivity. |

Important Note: This document represents the regulatory clearance process (510(k)) based on substantial equivalence, not a clinical trial or performance study report. Therefore, it does not contain the detailed study information typically found in such reports.

The following points cannot be answered from the provided text:

• Sample size used for the test set and the data provenance: Not applicable, as this is a regulatory submission based on substantial equivalence, not a clinical study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 physical implant, not an AI or imaging diagnostic tool that would involve human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Substantial equivalence relies on comparison to known predicate devices, not on a new ground truth established for this specific device.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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