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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells are modifications to the Novation Crown Cup with InteGrip acetabular shell devices cleared through premarket notification #K102975. The predicate and proposed devices have the same intended use and basic fundamental scientific technology. The modified devices share the following similarities with the predicate devices: Indications for use, Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature, anti-rotational feature, and product scope), Material (titanium alloy), Shelf life (10 years), Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10th). This submission proposes the following design change: Addition of cut-outs on the outer diameter to accommodate optional augment attachments. Addition of InteGrip Revision Acetabular Shells with 9 or 12 holes, depending on shell size, for additional adjunctive screw fixation.

The provided text is a 510(k) summary for a medical device (Exactech® InteGrip™ Acetabular Shells). This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, specifically for diagnostic accuracy or performance improvement for AI/ML devices.

Here's why and what information is present:

• Device Type: This is an orthopedic implant (acetabular shell for hip replacement), a physical medical device, not an AI/ML diagnostic or therapeutic software.
• Regulatory Pathway: A 510(k) Special pathway is used for modifications to a previously cleared device. The primary goal is to show the modified device is substantially equivalent to the predicate device (K102975 Novation® Crown Cup™ with InteGrip™).
• Proof of Performance: Substantial equivalence for this type of device is typically demonstrated through:
  • Engineering Analyses: The document explicitly states "The following engineering analyses were conducted to demonstrate substantial equivalence... Evaluation to assess InteGrip Revision Acetabular Shell screw hole number and placement. Evaluation to assess cut-out placement on the acetabular shells." This involves mechanical testing, simulations, and design reviews, not clinical studies with human readers or AI algorithms.
  • Material Equivalence: Stating similar materials and manufacturing processes.
  • Intended Use Equivalence: Demonstrating the modified device has the same intended use.

Therefore, I cannot provide a table of acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details as these concepts are not applicable to the information provided in this 510(k) submission for an orthopedic implant.

The document discusses "acceptance criteria" only in a regulatory sense (i.e., meeting the requirements for 510(k) clearance based on substantial equivalence), not performance thresholds from a clinical study.

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