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The Inter-On Porous Revision Shell with Sealable Screwholes is a porous coated hemispherical shell that is used in conjunction with a snap-in acctabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPE). This device is intended to replace the acetabulum during total hip arthroplasty and may be implanted with or without bone cement. Diagnostic indications for use of this device include:

• revision of a previously implanted acetabular prosthesis;
• patient conditions of noninflammatory degenerative joint disease: e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies: and,
• inflammatory joint disease; e.g., rheumatoid arthritis.

The Inter-On Porous Revision Shell with Sealable Screwholes is a hemispherical metal shell that is utilized with a snap-in polyethylene insert. The shell is manufactured from Ti-6Al-4V alloy and coated with Cancellous Structured Titanium™ (CSTT™). The insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is available in standard, hooded and hooded protrusio designs in order to address various clinical situations.
The Revision Shell with Sealable Screwholes is designed for screw application with nine screwholes allowing for screw placement into the illum, ischium and pubis. Furthermore, those screwholes that are not utilized may be plugged after implantation thus limiting the potential for fibrous tissue growth into the shell upon cement extrusion or cement extrusion into the shell upon cemented application. Additionally, if wear of the polyethylene acetabular insert occurs, the hole plugs restrict the debris from migrating through the acetabular shell holes into the acetabulum.
The integrity of the locking mechanism of the Revision Shell was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.

The provided document is a 510(k) summary for the Inter-Op™ Porous Revision Shell with Sealable Screwholes. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a detailed study with acceptance criteria and performance metrics in the way modern AI/software device submissions would.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance numbers, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in this type of document.

The document implicitly "proves" the device meets acceptance criteria by asserting:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is the "acceptance criteria" in essence for this type of submission.
• Mechanical Testing: It mentions that "The integrity of the locking mechanism of the Revision Shell was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices." This implies that the locking mechanism met some internal standard or performed comparably to competitors, which would be an "acceptance criterion" for that specific feature.

Given the nature of the document, I cannot generate the requested table and detailed study information because it is not contained within the provided text.

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