(102 days)
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.
| Acceptance Criteria (Demonstrated Similarity to Predicates) | Reported Device Performance (Kelyniam CCI) |
|---|---|
| Intended Use: Correct bony voids in the craniofacial skeleton | Intended to correct bony voids in the Craniofacial skeleton. |
| Material: PEEK-OPTIMA LT1 | Composed of Invibio Polyether Ether Ketone (PEEK-OPTIMA®), specifically PEEK-OPTIMA LT-1. |
| Form/Customization: Patient-specific, fabricated from CT data | Fabricated using the patient's computed tomography (CT) imaging data, customized to each individual patient's specific CT data. |
| Sterilization State: Non-sterile | Provided non-sterile for steam sterilization prior to implantation. |
| Sterilization Method: Steam | Recommended sterilization method is steam sterilization. |
| Method of Fixation: Attached to native bone with commercially available fixation systems | Attaches to native bone using commercially-available cranioplasty fasteners. |
| Device Type: Single use, non-load bearing | Single use, non-load bearing device. |
| Contraindications: Not for endosseous dental implants, not in maxillofacial/oral regions where use may be compromised | Will not be used on maxillia bones affecting dental implants. Not for use in skeletal structures in the maxillofacial and/or oral regions. |
| Size Range: Length/Width 50mm² - 150mm², Thickness 2mm - 4mm | Length/Width: (50mm² - 150mm²), Thickness: 2mm - 4mm, nominal thickness 3mm. |
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.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).