(111 days)
The Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained frauma or disease. The patient population is pediatric, including 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.
The 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-6A1-4V ELI. The system is implanted using Class II and Class I exempt instruments. All implants and instruments in the system are provided non-sterile.
This FDA 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML-driven devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and standard performance testing.
Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported device performance in the context of an AI/ML study. It refers to:
| Category | Acceptance Criteria (implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance with ISO 10993-1 | "performed in conformance with ISO 10993-1" |
| MR Safety | Compatibility with MR environment | "were determined to be MR Conditional" |
| Mechanical Performance | Meets design input requirements based on intended use and applicable standards (ASTM F1264, ASTM F543) | "was conducted to demonstrate that the Pediatric Nailing Platform |
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
None of the above information can be extracted from the provided document. The document describes a traditional medical device (intramedullary nail) rather than an AI/ML-driven device. The performance data mentioned refers to biocompatibility, MR safety, and mechanical testing against recognized standards (ASTM F1264 and ASTM F543) to demonstrate the physical properties and safety of the implant, not to the performance of an algorithm or its impact on human readers.
§ 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.