Search Results

The T2® Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.

The provided text is a 510(k) summary for a medical device (T2® Recon Nail System Line Extension) and does not contain detailed information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically found for AI-driven or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. For medical implants like this, the "study" is primarily mechanical and functional testing, and "acceptance criteria" are based on meeting established standards or demonstrating equivalence to the predicate device's performance.

Here's an attempt to extract the information you requested, based on the provided text, and highlighting what is not available in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like an intramedullary nail, specific numerical acceptance criteria (e.g., fatigue strength, torsional stiffness, bending strength) would be defined in testing protocols but are not detailed in this 510(k) summary. The summary focuses on assuring the FDA that the new device performs "comparably" to the already-cleared predicate.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided 510(k) summary. For mechanical tests, the "sample size" would refer to the number of devices tested, not human subjects or data sets. The data provenance would be from internal lab testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to this type of device submission. Ground truth, in the context of device performance, relates to mechanical and material properties, not expert-derived clinical outcomes or image interpretations.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. Adjudication methods are typically used for clinical endpoints or image interpretation, not for mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance Study

This is not applicable to this type of device. There is no algorithm for this implant.

7. Type of Ground Truth Used

For this device, the "ground truth" would be established through engineering standards, material specifications, and validated mechanical testing methods. The performance of the predicate device would also serve as a reference for comparison.

8. Sample Size for the Training Set

This is not applicable to this type of device. There is no "training set" in the context of mechanical device testing; this term applies to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as above.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the study that proves the device meets acceptance criteria is:

• Functional and mechanical testing: "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject T2® Recon Nail System to the predicate device."

The core thrust of this 510(k) submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (also the T2® Recon Nail System, but presumably an earlier version or one without the new set screw design). The "acceptance criteria" are thus implicitly met if the new design performs comparably to the predicate device in terms of materials, intended use, indications for use, and mechanical/functional properties. Specific test results and detailed criteria are usually found in the full 510(k) submission, not typically in the public summary.

Ask a specific question about this device