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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.

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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
• Subtrochanteric fractures
• Intertrochanteric fractures
• Comminuted fractures .
• Segmental fractures
• Fracture with bone loss
• Proximal and distal fractures
• Non-unions and malunions

The Dyna Locking Trochanteric Nail™ consists of intramedullary rod, neck screw assembly(neck screw + wedge wing), locking screw, fixed nail cap, slidable nail cap, end cap, and short end cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for passing of neck .screw and for fixation to bone by means of locking screws, respectively. The neck screws are inserted into the proximal hole of rod angle with 120, 125, 130, 135 degrees, selectively. The wedge wing in the neck screw prevents the twisting of the neck screw in the femoral head. The fixed & slidable nail cap are fixed in the rod to prevent operation failure due to the excessive motion of neck screw. The fixed nail cap prevents the rotation and movement of neck screw, but slidable nail cap is applicable only for rotation. Meanwhile, the end cap (or short end cap) screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. The end cap is used primarily, however short end cap which do not protruding out of nail also may be used according to patients' conditions. All implants of Dyna Locking Trochanteric Nail " are single use device, supplied non-sterile and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Trochanteric Nail™

This document describes the Dyna Locking Trochanteric Nail™, an intramedullary fixation system. The testing described is non-clinical (bench testing) to establish substantial equivalence to predicate devices, not a study involving human subjects or AI algorithms. As such, many of the requested categories are not applicable to this submission.

Here's the breakdown of the information provided in the context of your request:

Acceptance Criteria and Device Performance

The submission states that the "testing met all acceptance criteria and verifies that performance of the Dyna Locking Trochanteric Nail™ is substantially equivalent to the predicate devices." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it implies successful comparison to the predicate devices.

Study Details (Not applicable for this type of device and submission)

Given that this is a 510(k) premarket notification for a medical implant and the study described is non-clinical bench testing, many of the requested details about human-in-the-loop performance, AI, and ground truth for clinical data are not present.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing. The document does not specify the number of devices tested for each bench test. Data provenance (country of origin, retrospective/prospective) is not relevant to non-clinical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., expert consensus on images or pathology results) is not relevant to mechanical bench testing. The "ground truth" for these tests would be the established engineering standards or the performance of predicate devices.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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. This submission is for a physical medical device, not an AI or imaging diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical AI performance. For bench testing, the "ground truth" is defined by established engineering principles and performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI algorithm.
8. How the ground truth for the training set was established: Not applicable.

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