(90 days)
The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.
The Biomet® Tibial Locking Nail System is an intramedullary nail, designed to be inserted through the proximal tibia and proceed down the intramedullary canal of the tibia. The nail has both a proximal and distal bend to accommodate the anatomy of the tibia. Features include an internal locking/compression mechanism, a dynamization/locking slot, and numerous screw configurations to enable nail fixation.
The provided text describes a 510(k) premarket notification for the Biomet® Tibial Locking Nail System. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-based device.
Therefore, this submission does not contain information regarding acceptance criteria and a study proving a device meets those criteria in the way typically expected for an AI/algorithm device.
Here's why and what information is available from the provided text:
- Type of Device: The Biomet® Tibial Locking Nail System is a physical medical device (an intramedullary nail), not an AI/algorithm-based diagnostic or assistive device.
- Regulatory Pathway: The submission is a 510(k) premarket notification, which seeks to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This pathway relies heavily on comparing technological characteristics and intended use.
- Lack of Performance Study: The document explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." Under "Non-Clinical Testing": "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This non-clinical testing refers to mechanical or material testing to ensure the nail functions as intended, not a statistical study with specific performance metrics (like sensitivity, specificity, or accuracy) against a ground truth.
Therefore, it is impossible to fill out the table and answer the subsequent questions as they pertain to performance criteria and studies for an AI/algorithm device.
What information can be extracted, albeit not in the requested format for an AI/algorithm study:
- Device Name: Biomet® Tibial Locking Nail System
- Intended Use: "The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis."
- Predicate Device: Titanium Intramedullary Rods-Various (Uniflex® Tibial Nail (Low Profile) - K982953 (Biomet Inc.))
- Basis for Substantial Equivalence: Comparison of technological characteristics (materials, design, sizing, articulating surface, indications) and non-clinical laboratory testing demonstrating functionality within intended use.
In summary, the provided document is not relevant to the requested format for describing acceptance criteria and a study proving device performance for an AI/algorithm. It describes a traditional medical device following a 510(k) pathway.
§ 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.