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PEEK Customized Cranial Implant Kit is intended to be used to replace bony voids in the cranial and the craniofacial skeleton.

The PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.

PEEK Customized Implant Kit consists of the PEEK Customized Cranial Implant or the PEEK Customized Craniofacial Implant, the Host Bone Model, and the Design Proposal.

PEEK Customized Cranial Implant: The PEEK Customized Cranial Implant is a customized patient-specific implant based on CT-data and input by the surgeon. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the cranial skeleton. It is delivered non-sterile.

PEEK Customized Craniofacial Implant: The PEEK Customized Craniofacial Implant is a customized patient-specific implant based on CT-data. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the craniofacial region (orbital rim, zygoma, and adjacent bone). The implant matches the shape and dimensions of the missing bone fragments. It is delivered non-sterile.

The host bone model is provided as a preoperative guide to demonstrate orientation and fit of the Peek Customized Cranial Implant. The Design Proposal is a presentation of virtual 3-dimensional models of the implant design. The PEEK Customized Cranial Implant is offered in different sizes based on the size of the cranial defect. Depending on the surgeon's preference, the PEEK Customized Cranial Implant may be constructed in varying thicknesses, wall designs, number of dura suture holes and dura suture hole diameters. The PEEK Customized Cranial Implant is fixated to the native bone with Stryker Neuro, Midface or Upperface self-tapping screws. The PEEK Customized Cranial and Craniofacial Implant Kit is bundled with an online ordering system called "eRequest Lifecycle", whereby the user can initiate a case request, upload the patient specific image data, download the Design Proposal and approve the implant design.

This document describes the PEEK Customized Cranial Implant Kit, a custom patient-specific implant intended to replace bony voids in the cranial and craniofacial skeleton. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving independent performance against specific acceptance criteria. Therefore, several requested details about acceptance criteria, study design, and ground truth are not explicitly provided in the document as it's a 510(k) submission for a medical device, not an AI/ML algorithm.

However, based on the provided text, the following information can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for a physical medical implant, the "acceptance criteria" are primarily related to mechanical properties, material compatibility, and fit, rather than performance metrics like sensitivity or specificity typically seen in AI/ML performance studies. The "reported device performance" refers to the results of various physical tests.

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

The document mentions a "Cadaver Lab" for handling tests and various "performance tests" (stability, trimming, drilling, screw insertion, screw pull-out). However, the specific sample sizes for these tests are not provided. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for these physical tests is not specified.

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

For the "handling test performed in a Cadaver Lab," it states that "surgeons demonstrated that the implants met the user needs and fit the defects."

• Number of experts: Not explicitly stated, but implies multiple surgeons were involved.
• Qualifications of experts: Identified as "surgeons." No further specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set:

Given the nature of the tests, a formalized adjudication method like 2+1 or 3+1 is not applicable. The "handling test" involved surgeons demonstrating fit and meeting user needs, implying a qualitative assessment of suitability. The mechanical tests would have objective pass/fail criteria based on quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices or AI algorithms where human reader performance is a key metric. This submission is for a physical implant.

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

Yes, in the context of the device's design process. The document describes a "Virtual Implant Design Process (VIDP)" using CT-data to generate a 3D model and design the implant. This design process, which is an algorithm-driven component, is described as "validated." The performance data for the physical implant itself (mechanical strength, integrity) would be considered "standalone" as it's testing the final product independent of the human intervention during design approval.

7. The Type of Ground Truth Used:

• For mechanical tests (stability, trimming, drilling, screw insertion, screw pull-out): The ground truth would be based on engineering specifications and established mechanical properties of native bone (implicitly, as the device aims for "comparable to native skull" strength).
• For the handling test in the Cadaver Lab: The ground truth was based on expert consensus/qualitative assessment from surgeons regarding fit and user needs.

8. The Sample Size for the Training Set:

This question primarily applies to AI/ML algorithms that learn from data. While the device design uses patient CT data, the document does not describe it as a "training set" in the machine learning sense. The "Virtual Implant Design Process (VIDP)" is described as "validated," implying that the rules, algorithms, and processes for custom implant design were developed and verified, but it doesn't refer to a statistical "training set" of patient cases for an AI model to learn from.

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

Again, this question is not directly applicable in the AI/ML sense to this 510(k) submission. The "ground truth" for the "Virtual Implant Design Process" would refer to the accuracy and validity of the 3D modeling and design algorithms in replicating the desired anatomical structures and ensuring proper fit based on CT data. This would be established through engineering validation, potentially against known anatomical models or validated software outputs, during the development of the VIDP itself. The document states a "validated 'Virtual Implant Design Process' (VIDP)" is used, but doesn't elaborate on the validation specifics.

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