(494 days)
KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.
KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.
KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.
Patient-specific metallic bone plates are used in conjunction with metallic bone screws for internal fixation of maxillofacial, midface, and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.
Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the KLS Martin Individual Patient Solutions device primarily revolve around demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the device, particularly for the expanded pediatric population and new specifications. The performance is assessed through various non-clinical tests and a review of clinical literature.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Material Properties | Biocompatibility (ISO 10993-1) | Cytotoxicity, chemical analysis, sensitization, irritation, and chemical/material characterization leveraged from predicate/reference devices for titanium, synthetic polymers, and acrylic resins. New photopolymer resin for splints passed cytotoxicity, sensitization, irritation, and material-mediated pyrogenicity testing. |
| Mechanical Properties | Bending Resistance and Fatigue Life (ASTM F382) | Determined to be substantially equivalent to K943347 plates (reference device). New worst-case midface, orbit, and mandible plate designs were tested. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (ISO 17665-1:2006) | Validations for titanium devices leveraged from K191028. Validations for synthetic polymers and acrylic resins leveraged from K182789. New photopolymer resin for splints also underwent sterilization validation, with acceptance criteria met. |
| Pyrogenicity | LAL endotoxin testing (AAMI ANSI ST72) | Endotoxin levels below USP allowed limit for medical devices, meeting pyrogen limit specifications. Leveraged from K191028 for titanium devices. |
| Software Performance | Software Verification and Validation | Objective evidence that all software requirements and specifications were correctly and completely implemented, traceable to system requirements. Demonstrated conformity with predefined specifications and acceptance criteria. |
| Clinical Performance (Pediatric Expansion) | Risk mitigation assessments (FDA Guidance "Premarket Assessment of Pediatric Medical Devices") and review of peer-reviewed clinical literature. | Risk assessments addressed various pediatric risk factors. Six clinical studies (patients 18 months to 18 years) were analyzed to support safety and effectiveness in pediatric subpopulations (2 to |
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.