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Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus

The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the LOQTEQ® Elbow System (K132787 and K140607), to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. aap already offers a system of two plates for treatment of distal Humerus fractures: these are the anatomical shaped Plates LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal Medial Humerus Plate. Typically these devices are used together for one fracture and are placed under 90° orientation. The devices are already registered under the premarket notification K132787. Depending on the surgeons education some doctors prefer to use a different placement of the two plates. Therefore aap wants to add a further plate for the use in the identical intended use: this is the LOQTEQ® Distal Lateral Humerus Plate which is also used together with the LOQTEQ® Distal Medial Humerus Plate (see surgical approach above). In some rare indications this new device might be used as a standalone The anatomically performed plates are available as right and left version and in different lengths and with several shaft holes. The tapered end of the plate enables tissue-conserving, submuscular insertion. The tip of the shaft is tapered to allow a minimally invasive surgical technique. The bottom of shaft area is structured and tunnelled by cross grooves to minimize bone contact. All shaft holes, with the exception of the elongated hole are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The round locking holes are suitable for locking screws as well as cortical screws. The locking screws allow evening catching very small fragments. The design of the so-called glide holes allows angle stable fixation and proximal compression of bone fragments at the same time if LOQTEQ® Cortical Screws are used. The use of standard cortical bone screws leads to a non-angle stable fixation. A compression of the bone fragments can be realised, if the screws are positioned eccentric inside the glide hole. If the screws are placed directly in the locking part of the gliding hole, no compression occurs. The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of: LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 2.5, small head, T8, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate

This is a 510(k) Premarket Notification for a medical device, specifically bone fixation plates, and does not involve AI or machine learning. Therefore, the requested information about acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable to this document.

The document discusses the substantial equivalence of the "aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5" to a legally marketed predicate device (Synthes (USA): 3.5 MM LCP Distal Humerus System). The acceptance criteria and "study" are engineering analyses focusing on mechanical performance.

Here's the relevant information extracted from the provided text regarding the device's acceptance criteria and the "study" proving it:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This is an engineering analysis/mechanical testing, not a clinical study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized engineering protocols and measurements, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a bone plate, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical performance data, the ground truth is based on physical scientific measurements and established engineering standards for bending strength, bending stiffness, bending structural stiffness, and fatigue strength.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "study" (Performance Data):
"An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength. The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device."

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