(86 days)
The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.
The TRIGEN META-NAIL Antegrade Tibial Nail is indicated for stable and unstable fractures of the proximal and distal third of the tibia, including the shaft.
The TRIGEN META-NAIL Nail Systems is designed to be used for internal fixation of long bones in skeletally mature patients. The Subject TRIGEN META-NAIL Systems include TRIGEN Retrograde Femoral, Supracondylar and Tibial Nails (K051557, 6/30/2005), TRIGEN Meta-Nail Retrograde Femoral and Tibial Nails and TRIGEN META-NAIL Nail Cap Set Screw (K061019, 6/6/2006). The subject Smith & Nephew TRIGEN META-NAIL Systems devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails are intended for the internal fixation of long bones in skeletally mature patients. The TRIGEN META Antegrade Tibial Nails and the TRIGEN META Retrograde Femoral Nails have a round, cannulated geometry and are composed of biocompatible titanium alloy (Ti-6AI-4V complied to ASTM F1472/ISO 5832-3). The TRIGEN META-NAIL Antegrade Tibial & Retrograde Femoral Nails are provided preassembled with polyethylene sleeves, which are manufactured from ultra-high molecular weight polyethylene (UHMWPE)] conforming to ASTM F648 and ISO 5834-2. The TRIGEN META Antegrade Tibial Retrograde Femoral Nailing System also include nail cap set screws. The META Nail Cap Set Screw is also composed of the same Titanium alloy (TI-6Al-4V) as the nail implants. These implants are design to provide a solution for fracture fixation and are offered in a variety of diameters (8.5-13mm) and lengths (16-50cm). The implants within this system are single-use and are Gamma sterilized.
I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and a study proving device performance. The document is primarily a 510(k) premarket notification for a medical device (TRIGEN META-NAIL Nail System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's why I cannot fulfill your request and what the document does say:
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No Acceptance Criteria or Performance Data Presented: The document explicitly states: "These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled. Therefore, since there are no changes to the design features, materials, or manufacturing methods of the subject TRIGEN META-NAIL Nail System devices, no performance testing (bench, animal, clinical) was required." This means there is no new study or performance data presented in this particular submission to establish acceptance criteria or demonstrate performance.
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Focus on Substantial Equivalence: The entire submission is built on the premise that the TRIGEN META-NAIL Nail System is "substantially equivalent" to predicate devices (K051557, K061019, K981529). Substantial equivalence means that the device has the same intended use as a predicate, and either has the same technological characteristics or, if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
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Labeling Updates, Not Device Changes: The purpose of this 510(k) is specifically for "labeling updates which include indication updates in IFU/Package Insert." It states: "There are no significant changes in design, technological characteristics, function, sterilization and packaging of the devices, as a result of this submission."
Therefore, I cannot extract information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document does not contain the kind of study data you are asking for because none was required for this particular submission (a labeling update for an already cleared, substantially equivalent device).
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.