(62 days)
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from Titanium (Ti-6Al-4V ELI) which are used to treat fractures of the femur.
The provided text describes a 510(k) premarket notification for a medical device called the "Long Trochanteric Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested elements about acceptance criteria and study design are not available in the provided document. The document explicitly states:
- "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails."
- "The Trochanteric Nail System has the same intended use, is manufactured from the same material and has the same design features as the predicate devices and is therefore substantially equivalent."
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The submission focuses on substantial equivalence based on intended use, materials, and design features compared to predicate devices, not on specific performance metrics or acceptance criteria for a new clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment is described as there is no clinical performance study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is described.
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 / Not provided. This device is a bone fixation device (intramedullary nail), not an AI-powered diagnostic or imaging device, so an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is described.
8. The sample size for the training set
- Not applicable / Not provided. No training set is described for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No ground truth for a training set is established.
Summary from the document:
The provided 510(k) summary for the "Long Trochanteric Nail System" relies on demonstrating substantial equivalence to existing legally marketed predicate devices for its clearance. This means the manufacturer presented evidence that their new device shares the same intended use, materials (Titanium (Ti-6Al-4V ELI)), and design features as the predicate devices. The listed predicate devices are:
- ACE Trochanteric Nail (K010780)
- ACE AIM Femoral Nail (K871539)
- Synthes Proximal Femoral Nail (K973240)
- Smith & Nephew TriGen Nail (K981529)
The basis for acceptance is this demonstration of substantial equivalence, rather than a clinical study with specific performance criteria for the new 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.