Search Results

The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:

• Pertrochanteric fractures
• Intertrochanteric fractures
• Comminuted fractures
• Segmental fractures
• Fracture with bone loss
• Proximal and distal fractures
• Non-unions and malunions
• Subtrochanteric fractures(only for long nail: more than 320mm)

Dyna Locking Trochanteric Nail™ is consists of Trochanteric Nail for Femur, Neck Screw, Locking Screw for Distal Fixation, and Caps. Distal end part has hole and slot on the transverse direction for screw fixation. Proximal part is designed for neck screw and quide pin which is for insertion of anti-rotation quide wire. Above Neck screws have two types: built-in wedge wing type and without wedge wing type. A built-in wedge wing Neck screw is used as an assembly, and a without wedge wing can be used alone. A user can select the type of Neck screw according to the condition of the patient. Distal part of trochanteric nail uses the cortical type screws. All implants are single use only.

This document is a 510(k) Pre-market Notification from the FDA, which primarily focuses on establishing substantial equivalence of a new medical device to a previously cleared one. It does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria in the way you've outlined.

Specifically:

• This document describes a medical device (Dyna Locking Trochanteric Nail™) and its intended use, and argues for its substantial equivalence to a predicate device.
• It states that "Mechanical strength evaluations per ASTM F543 and geometrical comparisons to the predicate device demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." This is the extent of the performance testing information provided.

Therefore, most of the information requested in your prompt (detailed acceptance criteria tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this type of FDA clearance letter. These details would typically be found in the full 510(k) submission, which is a much more extensive document but not publicly available in this format from the FDA's website.

Based on the provided document, here's what can be answered:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document mentions "Mechanical strength evaluations per ASTM F543" as the basis for evaluation. ASTM F543 specifies mechanical test methods for metallic internal fixation devices. The acceptance criteria would be that the device meets the performance requirements (e.g., strength, stiffness, fatigue life) defined by this standard for intramedullary fixation rods, and that its performance is equivalent to or better than the predicate device.
• Reported Device Performance: The document states: "Mechanical strength evaluations per ASTM F543... demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." No specific numerical performance values or detailed acceptance criteria are listed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document only references "Mechanical strength evaluations per ASTM F543" which implies bench testing on device samples, not studies involving patient 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. This type of information is relevant for AI/ML device studies involving human interpretation or clinical outcomes, not for mechanical device equivalence assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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

• No. This is a mechanical device, not an AI diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM F543 standard.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

In summary, the provided document is an FDA 510(k) clearance letter for a mechanical orthopedic implant, asserting its substantial equivalence to a predicate device based on mechanical testing. It does not involve AI/ML technology or detailed clinical studies with human readers or patient data in the way your prompt describes.

Ask a specific question about this device