(48 days)
The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2™ Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- Fractures distal to hip joint ●
- Nonunions and malunions .
The T2™ Femoral Nail is a line extension to the T2™ Femoral Nail System. The T2TM Femoral Nail, in combination with the accessories from the predicate T2™ Femoral Nail Systems, is designed to treat various types of fractures of the femur.
This document describes a 510(k) premarket notification for a line extension to the T2™ Femoral Nail system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a study demonstrating performance against specific acceptance criteria. This type of submission relies on engineering analysis and comparison to existing devices. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable to this document.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numeric or qualitative acceptance criteria are provided in the document, nor is there a study detailing the device's performance against such criteria. The document states that "An engineering analysis demonstrated comparable strengths to the predicate components and is substantially equivalent to these devices." This implies that the 'acceptance criteria' are met by demonstrating equivalence to the predicate device's established performance characteristics, which are not detailed here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Comparable strengths to the predicate components" |
| Not specified | "Substantially equivalent" to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This submission relies on an engineering analysis and comparison to a predicate device, not clinical or performance testing with a 'test set' of subjects/data in the way described for AI/diagnostic devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. See point 2.
4. Adjudication Method for the Test Set:
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a medical device (intramedullary nail) submission, not an AI or diagnostic device that would typically involve an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable in the context of clinical "ground truth" as typically used for AI/diagnostic devices. The "ground truth" in this context is the established performance and safety profile of the predicate T2™ Femoral Nail system, which the new device aims to be substantially equivalent to, as supported by an engineering analysis.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. See point 8.
§ 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.