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The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).

Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is an individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone), ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long. A Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a specific patient's skull whereas a Customized Craniofacial Implants (CCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, which are both considered load bearing areas of the facial region of the skull. The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific Base Implant that are used to support the base implant in the bony void or defect area while providing for a "Precise Fit". The single patient use base implant is (1) fabricated from a billet block of natural implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer using the patient's CT Scan imaging data, (2) provided clean but non-sterile for steam sterilization prior to implantation at a hospital or surgical site with neurosurgery capabilities, and (3) attached to the native bone using commercially available cranioplasty hardware and fasteners. The additional features listed below are additional design elements that may be added to the Base Implant and Base Implant with Perfusion Holes, as requested by the Physician. The Base Implant, as defined above (as previously cleared on K103582 and K121755).

The provided document outlines the Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) for which a 510(k) premarket notification (K182711) was submitted.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria versus reported device performance for specific clinical or diagnostic metrics. Instead, the "Performance Data" section details the types of validations and tests conducted to demonstrate the device's substantial equivalence to predicate devices and its safety and effectiveness.

Here's a summary of the performance data and "accepted" findings:

• Risk assessment conducted to evaluate the impact of design changes on biocompatibility.
• Result: Subject device meets biological safety requirements per ISO 10993-1 for permanently implanted devices with tissue/bone and cerebrospinal fluid contact. |
  | Material Specification Compliance | - Invibio PEEK Optima LT-1® and Evonik Vestakeep i4® Material Specifications and Certification of Analysis/Certification of Compliance reviewed against approved specifications.
• Result: Accepted against approved specifications at each receipt as part of receiving inspection activities. Conforms to ASTM F2026-16 Standard Specification for Polyether ether ketone (PEEK) Polymers for Surgical Implant Applications. |
  | Cleaning Validation | - Conducted in accordance with ANSI/AAMI ST72:2011, USP , USP , EP 2.6.14, and JP 4.01.
• Result: All samples passed the acceptance criteria. |
  | Steam Sterilization Validation | - Conducted in accordance with ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 14937:2009.
• Result: All samples passed the acceptance criteria. |
  | Mechanical Testing (for non-load bearing implants) | - No industry-accepted standard exists.
• A Mechanical Testing Validation Protocol was developed by KGI.
• Result: All samples passed the acceptance criteria. (Specific criteria for this protocol are not detailed in the summary). |
  | Ship Testing Validation | - Conducted in accordance with FedEx Packaging Testing Under 150Lb (similar to ITSA-2A-2011).
• Result: All samples passed the acceptance criteria. |
  | MR Safety (Magnetic Resonance Compatibility) | - Evaluation of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
• Result: The implants are electrically nonconductive or a nonmagnetic item and pose no known hazards in all MR environments. KGI Customized Craniofacial (CCI) and Customized Skull (CSI) Implants are MR Safe. |
  | Overall Safety and Effectiveness/Substantial Equivalence | - Based on biocompatibility, steam sterilization, cleaning, mechanical, and ship testing, and comparison of indications for use, technology, and materials with predicate devices.
• Result: Device is safe and effective and substantially equivalent to the predicate devices. |

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for performance evaluation in the way one might for an AI/diagnostic device. The studies performed are primarily bench testing and material characterization studies.

• Sample Size: The sample sizes for the various bench tests (e.g., cleaning, sterilization, mechanical, ship testing) are not explicitly stated in the summary. It generally mentions "all samples passed the acceptance criteria," implying that a sufficient number of units were tested as per the respective validation protocols.
• Data Provenance: The data provenance is internal to the manufacturer (KGI) through their own validation protocols and testing, or from material suppliers (Invibio PEEK Optima LT-1® and Evonik Vestakeep i4®) for material specifications and certifications of analysis which are then reviewed by KGI. This data is generally considered prospective in the sense that the tests were conducted specifically to validate the device, rather than analyzed retrospectively from existing clinical datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is an implant (Customized Craniofacial/Skull Implant), not a diagnostic or AI device that requires expert interpretation for establishing ground truth in clinical cases. The "ground truth" for this device relates to its material properties, manufacturing quality, biomechanical integrity, and biocompatibility, which are verified through standardized testing and material certifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of device and studies performed. Adjudication methods are typically used in clinical studies, especially those involving human interpretation of diagnostic results, to reconcile discrepancies and establish a consensus ground truth. The studies cited are laboratory and bench tests relying on objective measurements and established standards.

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

This is not applicable. The device is a physical, custom-made implant, not an AI-powered diagnostic tool. Therefore, an MRMC study or an evaluation of human reader improvement with AI assistance is not relevant to this submission.

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

This is not applicable. The device is an implant. No algorithm or standalone AI performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this medical device is established through:

• Standards Compliance: Adherence to recognized national and international standards for biocompatibility (ISO 10993-1), materials (ASTM F2026-16), cleaning (ANSI/AAMI ST72, USP ), and sterilization (ANSI/AAMI/ISO 17665-1, 14937).
• Material Certifications: Certifications of analysis/compliance from raw material suppliers.
• Engineering Specifications: Internal KGI specifications and validation protocols for mechanical testing and ship testing.
• Objective Measurements: Laboratory measurements to confirm physical properties, absence of contaminants, and sterility.

No clinical outcomes data or pathology reports were used here as "ground truth" in this specific 510(k) summary, as the submission focused on demonstrating substantial equivalence through non-clinical testing. This is explicitly stated: "Clinical Testing was determined not applicable for Kelyniam Global Inc. Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI)."

8. The sample size for the training set

This is not applicable. The device is a physical implant and not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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