(58 days)
The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEO® VA Olecranon Plate 2.7/3.5.
LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for:
- Intra-articular fractures of the distal humerus
· Supracondylar fractures of the distal humerus
· Osteotomies, and non-unions of the distal humerus
LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for:
· Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone
The components of the LOOTEO VA Elbow Plates 2.7/3.5 are trauma implants, bone plates and screws, which are implanted into the human body to achieve an internal fixation of bone fragments, typically after fractures or other bone injuries (e.g., joint reconstruction). LOQTEQ plates function according to the fixateur interne principle, i.e., they incorporate an angular stable plate-screw connection as a result of screwing threaded screw heads into threaded plate holes. Conventional bone screws can be used in all plate holes and allow for off-axis angulation up to 15° inside threaded plate holes. After fracture healing, the implants (plates and screws) are to be removed.
The shape of the bone plates is adapted to the anatomy of and the biomechanical stress on the distal humerus and the olecranon (ulna), respectively.
The LOQTEQ VA Elbow Plates 2.7/3.5 consists of the LOQTEQ VA Distal Dorsolateral Humerus Plate, LOQTEQ VA Distal Lateral Humerus Plate, LOQTEQ VA Distal Medial Humerus Plate and the LOQTEQ VA Olecranon Plate 2.7/3.5.
This appears to be a 510(k) summary for a medical device (LOQTEQ® VA Elbow Plates 2.7/3.5) and not a study describing a new AI/ML-based medical device. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria, study design for AI performance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document.
The document discusses the following:
- Device Description: LOQTEQ® VA Elbow Plates 2.7/3.5 are trauma implants (bone plates and screws) for internal fixation of bone fragments after fractures or injuries, particularly in the distal humerus and olecranon. They function on the "fixateur interne principle" with an angular stable plate-screw connection.
- Predicates: The device demonstrates substantial equivalence to previously cleared predicate devices (K132787, K140607, K161696, and K120717).
- Performance Data: Non-clinical testing data was submitted, referencing or relying on the predicate devices. This included biocompatibility testing and validation of the recommended end-user moist heat sterilization cycle (according to ANSI AAMI ISO 17665-1). Mechanical testing against predicate device K120717 was completed.
- Clinical Data: "Clinical data were not submitted in this premarket notification."
Given the content, I cannot provide details on the acceptance criteria and study proving an AI/ML device's performance because this document pertains to a traditional medical device (bone plates) that did not include AI/ML components or require clinical performance data for its 510(k) clearance due to its substantial equivalence to predicate devices based on non-clinical testing.
The "acceptance criteria" for a traditional device like this primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering analysis, mechanical testing (as mentioned), material characterization, and biocompatibility, rather than clinical performance metrics in a study.
Therefore, many of the requested points related to AI/ML device studies (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training set details) are not applicable to this document.
§ 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.