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The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.

The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics:
• The implants are designed individually for each patient to correct defects in cranial bone.

• The implants are 3D printed using material extrusion technology.
• The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF).
• The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input.
• · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm.
• If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs.
• The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems
• The implants are provided non-sterile for sterilization prior to implantation.

The provided text describes the 510(k) premarket notification for the "VSP PEEK Cranial Implant," which is a Class II device intended to fill bony voids or defects in the cranial skeleton. The information pertains to a medical device's regulatory clearance rather than an AI/ML-driven device, so many of the requested criteria related to AI acceptance, ground truth, and human reader studies are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance.

Here's a breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance (Table)

There are two main categories of acceptance criteria and performance reporting mentioned: Biocompatibility and Performance Bench Testing.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of implants or test specimens) for each test. It uses phrases like "All samples" and "Several implantations."
• Data Provenance: The data is generated through laboratory bench testing and pre-clinical animal studies (rat model for implantation effects). The data origin is not specified by country, but it relates to the manufacturing and testing done by "3D Systems, Inc." located in Littleton, CO, USA. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

• Experts: For the Anatomical Fit Testing, "surgeons" were involved in performing simulated surgical procedures and reviewing the results.
• Qualifications: The general qualification is "surgeons." No specific number or detailed qualifications (e.g., years of experience, subspecialty) are provided in this summary.
• Ground Truth: For the "anatomical fit," the ground truth was established by the subjective assessment of "surgeons" performing simulated implantations on anatomical models and completing a questionnaire.

4. Adjudication Method for the Test Set

• For the anatomical fit, the document states "reviewed by each surgeon." This suggests individual assessments, but it doesn't specify a formal adjudication method (e.g., consensus, majority vote) if multiple surgeons were involved. It can be inferred that simple agreement among the involved surgeons was sufficient for the "acceptable" conclusion.
• For other analytical and mechanical tests, adjudication would be based on predefined quantitative thresholds or qualitative observations against standards.

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 primarily relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists interpreting images). The VSP PEEK Cranial Implant is a structural implant, and its performance evaluation does not involve differential human interpretation of medical images.

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

• Not applicable directly. This question primarily applies to AI/ML software devices. The "VSP PEEK Cranial Implant" is a physical device. While its design involves "CT imaging data and surgeon input," implying a design process that might be aided by software, the performance evaluation described here is for the physical implant itself, not a separate AI algorithm for image analysis or diagnosis. The "standalone" performance here refers to the device's intrinsic mechanical and biological properties.

7. The Type of Ground Truth Used

• Bench Testing Standards & Expert Consensus/Subjective Assessment:
  • For biocompatibility, the ground truth is established by international standards (ISO 10993 series) and the measured physical/chemical properties or biological responses compared against the acceptance criteria defined by these standards.
  • For mechanical performance, the ground truth is established by literature research (as "there is no industry accepted standard governing mechanical testing for non-load bearing implantable prosthetic plates") and internal technical specifications, and the device's ability to withstand forces.
  • For anatomical fit, the "ground truth" is based on the subjective assessment and "acceptance" by the surgeons performing the simulated implantations.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set. The design of each implant is "individually for each patient" using their specific CT imaging data and surgeon input, which is a custom manufacturing process rather than a machine learning training process.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth to establish for such a set.

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