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The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.

The proposed Exactech Novation InteGrip Acetabular Augments are a modification of the Exactech InteGrip Acetabular Augments cleared through premarket notification #K101761.

The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.

The modified devices share the following similarities with predicate devices:

• . Indications for Use
• Design Features (e.g. screw holes, height configurations)
• Material (titanium alloy) .
• . Shelf Life (5 years)
• Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°)

The proposed devices include the following design change:

• Expand the current scope of augments to include sizes that are compatible with . the Novation Crown Cup acetabular shell sizes 60-68mm (both plasma spray and InteGrip).

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

Therefore, many of the requested elements about acceptance criteria, study design, and ground truth are not applicable or documented in this type of regulatory submission. The summary explicitly states that equivalence was demonstrated through "engineering analyses."

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission is a 510(k) for substantial equivalence, which does not typically include a table of acceptance criteria and reported device performance in the way a clinical trial or performance study would. The equivalence is based on design features, intended use, materials, manufacturing processes, and engineering analyses comparing the new device to a predicate.

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

Not applicable. This submission relies on engineering analyses rather than a "test set" of clinical data.

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

Not applicable. No ground truth was established by experts for a test set in this context. The determination of substantial equivalence was made by the FDA based on the submitted engineering analysis and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used.

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

Not applicable. This device is a physical acetabular augment, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. There was no "ground truth" in the sense of clinical outcomes, pathology, or expert consensus used for performance evaluation. The basis for approval was substantial equivalence to a legally marketed predicate device, demonstrated through engineering analyses.

8. The Sample Size for the Training Set

Not applicable. No training set was used for an algorithm; this is a physical medical device.

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

Not applicable. No training set was used.

Summary of Device Performance and Substantial Equivalence (as reported in the document):

The Exactech® Novation® InteGrip™ Acetabular Augments (K113609) are a modification of the Exactech InteGrip Acetabular Augments (K101761).

Acceptance Criteria/Basis for Substantial Equivalence:

The primary "acceptance criteria" for this 510(k) submission were demonstrating substantial equivalence to the predicate device (Exactech InteGrip Acetabular Augments, K101761). This was achieved by showing:

• Identical Indications for Use: Both devices are indicated for use in skeletally mature individuals undergoing primary or revision hip replacement surgery for segmental acetabular deficiencies, as an alternative to structural allograft.
• Identical Basic Fundamental Scientific Technology: Both devices utilize the same core technology.
• Similar Design Features: Including screw holes and height configurations.
• Identical Material: Titanium alloy.
• Identical Shelf Life: 5 years.
• Identical Packaging and Sterilization: Gamma radiation sterilization to a sterility assurance level of 10⁻⁶.
• Engineering Evaluation: An evaluation was conducted to confirm that the geometric features of the proposed devices (specifically, new sizes compatible with Novation Crown Cup acetabular shells 60-68mm) correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the substantial equivalence criteria is an engineering analysis. The document explicitly states:

• "The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Exactech Novation InteGrip Acetabular Augments:
  • An engineering evaluation to determine that the geometric features of the proposed devices correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices."

The conclusion drawn from this analysis is: "In addition to the design similarities, the results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device."

In essence, for this 510(k), the "acceptance criteria" were the conditions for demonstrating substantial equivalence, and the "study" was the engineering evaluation that confirmed these conditions were met for the modified device.

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