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Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are 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, 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 Fusion Skull Implant (FSI) is intended to fill a bony void or defect area in a specific patient's skull, whereas a Fusion Craniofacial Implant (FCI) 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, 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. These design elements are used to support the base implant in the bony void or defect area to provide a "Precise Fit."

The single-use alterable base implant (1) is fabricated from a billet block of implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer formulated with biphasic calcium phosphate (BCP PEEK), using a patient's CT scan imaging data, (2) is provided clean (non-sterile) for steam sterilization prior to implantation at a hospital or surgical site, and (3) are attached to the native bone using commercially available cranioplasty hardware and fasteners.

The provided FDA 510(k) clearance letter (K250334) addresses the marketing of the Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI). However, this document does not describe a study involving an AI model or a human-in-the-loop system.

The device described is a physical implant (Preformed Alterable Cranioplasty Plate) intended to fill bony voids or defects in the cranial and craniofacial skeleton. The review focuses on the substantial equivalence of this implant to previously cleared predicate devices, primarily based on material composition (a new PEEK formulation: BCP PEEK) and manufacturing processes.

Therefore, the requested information regarding acceptance criteria and studies proving an AI-driven device's performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be extracted from the provided text.

The performance data section in the document describes:

• Biocompatibility testing: Performed on the new material (Evonik Vestakeep iC4800R® BCP PEEK) according to ISO 10993 standards.
• Performance Testing: Refers to raw material certification and acceptance.
• Cleaning Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Steam Sterilization Validation: Conducted according to ANSI/AAMI ST79.
• Mechanical Testing Validation: A protocol developed by Kelyniam was used as there's no industry-accepted standard for non-load-bearing plates. It states that "all samples passed the acceptance criteria" and "performed equivalent to the predicate devices during mechanical testing using a worst-case scenario."
• Ship Testing Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Summary on Clinical Testing: States "Clinical Testing was determined not applicable" for these devices.

In summary, the provided document does not contain any information about an AI/software-based device, nor does it detail acceptance criteria or studies related to AI performance.

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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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The Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton.

The implant is composed of Invibio Polyether Ether Ketone (PEEK-OPTIMA®) and fabricated using the patient's computed tomography (CT) imaging data. The device is provided non-sterile for steam sterilization prior to implantation and is attached to the native bone with commercially available FDA approved cranioplasty fixation systems. The Kelyniam Customized Craniofacial Implant (CCI) is a single use, non-load bearing device which is not intended to support any endosseous dental implants nor be used in areas where their intended use may be compromised in a subsequent surgery in the ora!-maxillofacial area.

The implants will range in size from 50mm X 50mm X 150mm, and the thickness of the implant ranging from 2mm - 4mm with the nominal thickness of 3mm. The sizes and shapes of this implant may vary depending on the patients specific defect area. The implant will attach to native bone using commercially-available cranioplasty fasteners.

The Customized Craniofacial Implant (CCI) is used to correct bony voids of the craniofacial region to include the zygoma, orbital rim, and adjacent bone. The Customized Craniofacial Implant (CCI) will not be used on any of the Maxilla bones that will affect the placement of current or future oralmaxillofacial implants, including endosseous dental implants. Also, the CCI Implant is not for use in the skeletal structures in the maxillofacial and/or oral regions.

The Kelyniam Customized Craniofacial Implant (CCI) is a Class II medical device used to correct bony voids in the craniofacial skeleton. The 510(k) summary and associated documents for K121755 indicate that substantial equivalence to predicate devices was established rather than a study with specific acceptance criteria and performance metrics. Therefore, detailed acceptance criteria in the format of a clinical study are not directly applicable here.

Here's an analysis based on the provided text, focusing on how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence determination for a medical device (specifically a cranioplasty plate), the "acceptance criteria" are not reported as numerical performance targets from a clinical study, but rather as design and material characteristics compared to legally marketed predicate devices. The "reported device performance" is the demonstration that the subject device shares these characteristics and works in a similar manner.

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

No specific "test set" in the context of clinical trial data is mentioned. The demonstration of substantial equivalence relies on a comparison of the device's design, materials, and intended use with existing legally marketed predicate devices.

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

Not applicable in this context. Substantial equivalence is determined by regulatory review based on documented device characteristics and comparisons to predicates, not by expert consensus on a test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set or clinical study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or mentioned. This device is a physical implant, not a diagnostic or AI-assisted system where MRMC studies are typically relevant. The submission focuses on the safety and effectiveness being substantially equivalent to existing implants.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was conducted. Again, this device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is the safety and effectiveness record of the predicate devices. The Kelyniam CCI draws its claim of safety and effectiveness from demonstrating that it is substantially equivalent to these devices in terms of materials, design, manufacturing, sterilization, and intended use. The FDA's determination of "substantial equivalence" means the device is as safe and effective as the predicates.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of device submission, as it's not an AI/ML or diagnostic imaging device.

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

Not applicable.

Summary of the Study (Substantial Equivalence Argument):

The "study" presented here is a Substantial Equivalence Comparison as required for a 510(k) premarket notification. The Kelyniam Customized Craniofacial Implant (CCI) was compared against four predicate devices:

• Kelyniam Customized Skull Implant (CSI) (K103582)
• Synthes Patient Specific Craniofacial Implant (PSCI) (K053199)
• KLS Martin L.P. Patient Contoured Mesh - PEEK (PCM-P) (K072707)
• MedCAD AccuShape PEEK Patient Specific Cranial Implant (PSCI) (K110684)

The submission highlights the following points to argue for substantial equivalence:

• Material: All devices (subject and predicates) are made from PEEK, specifically PEEK-OPTIMA LT-1.
• Customization: All are patient-specific and customized from CT data.
• Sterilization: All are sold non-sterile and recommended for steam sterilization.
• Similarities in Basic Design and Function: The subject device shares fundamental characteristics with the predicates regarding its purpose (correcting bony voids), material, and manufacturing process.
• Differences and Justification:
  • The Kelyniam CCI has a slightly broader indicated use within the craniofacial region (including zygoma, orbital rim, and adjacent bone) compared to some predicates (like Kelyniam CSI and MedCAD Accuhape™ PEEK PSCI) which were limited to the cranial skeleton.
  • Crucially, the Kelyniam CCI explicitly states it will not be used on maxilla bones that would affect oral-maxillofacial implants, distinguishing it from potential broader applications of the predicates where this might be a concern.

The conclusion of the submission is that these similarities, and the careful delineation of differences (which do not raise new questions of safety or effectiveness), support the conclusion that the Kelyniam Customized Craniofacial Implant (CCI) is as safe and effective as the predicate devices. The FDA concurred with this assessment in its 510(k) clearance letter.

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Patient Specific Cranial implants are intended for the replacement of bony voids in the cranial skeleton.

The Kelyniam Custom Skull Implant (CSI) is designed individually for each patient to correct defects in cranial bone. The Kelyniam Custom Skull Implant (CSI) is individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial skeleton. The implants are composed of PEEK-OPTIMA, and are fabricated using the patient's CT imaging data. The implants are provided with .125" diameter pressure relief holes, equally spaced over the contour of the implant with .625″ centerline spacing and a minimum of .500″ edge margin. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners. This product is a single use device.

The provided text is a 510(k) summary for the Kelyniam Custom Skull Implant (CSI) and discusses substantial equivalence to predicate devices, but it does not describe acceptance criteria or a study that specifically proves the device meets acceptance criteria in the manner typically expected for AI/software-based medical devices (e.g., performance metrics against a clinical ground truth).

Instead, the submission appears to be focused on demonstrating substantial equivalence to existing legally marketed devices based on intended use, material, technical specifications, and sterilization. The "study" mentioned directly relates to a biocompatibility test (Toxicity), not a performance study in the context of diagnostic accuracy or a human-AI comparison.

Therefore, many of the requested sections will be answered as "Not Applicable" or "Not Provided" based on the content of the document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Information (Based on provided document)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Provided / Not Applicable: The document describes a biocompatibility (Toxicity) test using Limulus Amebocyte Lysate (LAL). This is a laboratory test on the device material, not a clinical study involving a "test set" of patient data or cases. The sample size would refer to the number of devices tested or the replicates of the LAL test, which is not specified but is typically much smaller than a clinical sample size. No country of origin or retrospective/prospective status is relevant or provided for this type of test.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable / Not Provided: Ground truth in the context of clinical performance (e.g., diagnostic accuracy) is not relevant to the LAL toxicity test. The "ground truth" for the LAL test is the regulatory standard for endotoxin levels.

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

   • Not Applicable / None: No adjudication method is relevant for a biocompatibility test.

4. 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: No MRMC study was done, as this device is a physical implant, not an AI-assisted diagnostic tool.

5. 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.

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

   • Regulatory Standard for Endotoxin Levels: For the toxicity test, the "ground truth" is the established regulatory limit for endotoxin levels in medical devices in contact with cerebrospinal fluid.

7. The sample size for the training set

   • Not Applicable: This is a physical medical device, not a machine learning algorithm that requires a training set. The device is custom-manufactured for each patient based on their CT imaging data, but "training set" is not relevant here.

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

   • Not Applicable: As there is no training set for an algorithm, this question is not relevant.

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