(21 days)
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus
The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.
The provided text describes a medical device, the "AOS Anterolateral Proximal Humeral Plate," which is a metallic bone fixation appliance. The document is a 510(k) premarket notification for modifications being added to the existing system. Crucially, the document explicitly states under the "CLINICAL DATA" section: "There is no clinical data referenced in this special 510(k)."
This means that no clinical study was conducted as part of this specific 510(k) submission to prove the device meets acceptance criteria. The claim of substantial equivalence for the modifications (adding 16 and 18-hole plates) is based on similarities to predicate devices and preclinical testing (though the document states mechanical testing was not necessary due to no anticipated decrease in strength or increase in risk).
Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this specific submission because the document explicitly states no clinical data was referenced.
The relevant information is:
- Acceptance Criteria and Reported Device Performance: Not applicable, as no clinical study was referenced for this submission. The submission relies on substantial equivalence to predicate devices and the absence of a need for new mechanical testing for the additions.
- Sample size for test set and data provenance: Not applicable, as no clinical study was referenced.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as no clinical study was referenced.
- How the ground truth for the training set was established: Not applicable.
§ 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.