(29 days)
Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease. The patient population is pediatric and includes child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.
Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' Pediatric Nailing Platform | Femur is for single use only.
Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6Al-4V ELI. The Pediatric Nailing Platform | Tibia was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.
Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. Pediatric Nailing Platform | Femur also offers end caps which are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.
The provided FDA 510(k) clearance letter for the OrthoPediatrics Pediatric Nailing Platform (Tibia and Femur) addresses a "Special 510(k)" submission. A Special 510(k) is typically used for changes to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology.
Based on the document, the key changes are related to sterilization, shelf life, and packaging. The performance data section explicitly states:
"The sterility, shelf life as well as the packaging of the subject sterile devices were supported by the sterilization validation and the packaging validation which includes aging and simulated transport."
And:
"An engineering analysis has been conducted that there is no impact of sterilization or aging on the products' performance and functionality."
This context is crucial because the "study that proves the device meets the acceptance criteria" in this case is not a clinical study involving human patients, but rather non-clinical performance testing focused on the impact of these manufacturing changes.
Therefore, the requested information about AI model performance, multi-reader multi-case studies, expert consensus for ground truth, and training set details are not applicable to this specific 510(k) submission. This is not a software-driven diagnostic device; it is a physical, implantable medical device.
Here's how to interpret the request in the context of this document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (as stated in document) |
|---|---|---|
| Sterility | Device must be sterile. | "The sterility... of the subject sterile devices were supported by the sterilization validation..." |
| Shelf Life | Device must maintain performance and sterility over a specified shelf life (stated as 5 years for subject device). | "...shelf life... supported by the sterilization validation and the packaging validation which includes aging and simulated transport." |
| "An engineering analysis has been conducted that there is no impact of sterilization or aging on the products' performance and functionality." | ||
| Packaging Integrity | Packaging must maintain sterility and protect the device from damage during transport and storage. | "...packaging validation which includes aging and simulated transport." |
| Biocompatibility | Device materials must compatible with the human body and not elicit adverse biological reactions. | "The biocompatibility of the non-sterile predicate devices was assessed and cleared under previous 510(k)s. A biocompatibility assessment has been conducted and upon review of all available information regarding the devices and proposed new packaging materials... no further biocompatibility testing is deemed necessary." |
| MR Safety | Device must remain MR Conditional. | "There is no impact to the MR safety and subject devices remain MR conditional." |
| Functional Performance | Device's core mechanical function (e.g., strength, stability) not impacted by changes. | "An engineering analysis has been conducted that there is no impact of sterilization or aging on the products' performance and functionality." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact sample sizes for the "sterilization validation," "packaging validation," or "engineering analysis." These are typically conducted according to recognized standards (e.g., ISO, ASTM) which dictate appropriate sample sizes for testing (e.g., for sterility, a certain number of units must pass tests; for aging, a specific number of packages are subjected to accelerated aging).
- Data Provenance: The data provenance is internal to OrthoPediatrics Corp., generated through their quality system and R&D processes as part of the 510(k) submission. It would be prospective for the specific tests conducted for this submission (e.g., packaging validation on new sterile packaging). The biocompatibility assessment references data from preceding predicate devices. The country of origin of the data is not specified beyond the company being based in Warsaw, Indiana, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. Ground truth for non-clinical performance (like sterility, shelf life, packaging integrity) is established through validated testing methodologies and engineering analyses, not by expert human interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required (e.g., clinical endpoint assessment, image reading). Here, acceptance is based on quantitative/qualitative results from engineering and validation tests meeting pre-defined specifications.
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
Not applicable. This submission is for a physical, implantable medical device, not an AI/software-as-a-medical-device (SaMD).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this special 510(k) is the successful demonstration of:
- Sterility: Absence of viable microorganisms as per validated sterilization methods.
- Shelf Life: Maintenance of device integrity and function after accelerated and/or real-time aging.
- Packaging Integrity: Package seals and materials remain intact and protective after challenging conditions.
- Biocompatibility: Established safety profile from predicate devices and assessment of new packaging materials/processes.
- Mechanical Performance: Confirmation via engineering analysis that the changes do not degrade the device's original mechanical properties.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.