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510(k) Data Aggregation
(203 days)
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
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.
| Test Performed | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| 4-point bend test of rods | Not explicitly stated (implied: performance substantially equivalent to predicate devices) | Met all acceptance criteria (implied: substantially equivalent to predicate devices) |
| Torsional test of rods | Not explicitly stated (implied: performance substantially equivalent to predicate devices) | Met all acceptance criteria (implied: substantially equivalent to predicate devices) |
| 3-point bend test of locking screws | Not explicitly stated (implied: performance substantially equivalent to predicate devices) | Met all acceptance criteria (implied: substantially equivalent to predicate devices) |
| Cutout test of neck screws | Not explicitly stated (implied: performance substantially equivalent to predicate devices) | Met all acceptance criteria (implied: substantially equivalent to predicate devices) |
| Dynamic compression test of full constructs | Not explicitly stated (implied: performance substantially equivalent to predicate devices) | Met all acceptance criteria (implied: substantially equivalent to 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.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
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