(137 days)
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.
The aap Plate and Screw System LOQTEQ Distal Fibula Plates consists of bone plates and bone screws, 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. The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic plate system. The anatomically preformed plates are available as right and left versions and in different lengths. The tapered end of the plate enables tissue-conserving, submuscular insertion. The 1.8 mm thin anatomic LOQTEQ Distal Fibula Plate 3.5 prevents skin and soft tissue irritation. All plate holes, with the exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws (gold). 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 partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left. LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping. Cortical Screw 3.5, T15, self-tapping. Cancellous Screw 4.0, small head, T15. Washer, I-Ø4.4, A-Ø8.0. Set of Instruments LOQTEQ Distal Fibula Plates 3.5. Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136). The surface of the plates is generated by an automatic slide finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well.
The provided text is a 510(k) Premarket Notification for a medical device, specifically the LOQTEQ® Distal Fibula Plate 3.5, Cancellous Screw 4.0, and Washer. This document primarily focuses on demonstrating the substantial equivalence of this new device to previously marketed predicate devices, rather than on proving the device meets specific performance criteria through a clinical study for a new, novel technology (like an AI algorithm).
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for an AI/ML medical device submission, are not applicable to this document.
Here's why and what information is available in the provided text:
- Type of Device: The device is a bone fixation appliance (metallic plate, screws, washer) used for internal fixation of the distal fibula. This is a traditional mechanical implant, not an AI/software as a medical device (SaMD).
- Regulatory Pathway: The submission is a 510(k) Premarket Notification, which aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove efficacy/safety through a de novo clinical trial that would require the kind of detailed study breakdown requested.
- "Study" described: The document mentions "Non-clinical tests" including:
- "Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
- "Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
- "Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
- "Acceptance Criteria" described: For these mechanical tests, the acceptance criteria are implicitly that the device performs "as good as or better than the predicate devices" and "fulfil the relevant demands of ASTM F543-13" and ASTM F382-99.
- Performance: The document states, "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The screws fulfil the relevant demands of ASTM F543-13. The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices."
- Clinical Data: The document explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence." This is a key indicator that the detailed clinical study information requested is not part of this submission.
In summary, none of the specific bullet points regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) can be extracted from this document because it is for a mechanical orthopedic implant, not an AI/ML diagnostic or therapeutic device. The "study" here refers to mechanical bench testing, not clinical performance or AI algorithm validation.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.