(88 days)
BRM TOOL Screws
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
BIOPLAN Subtalar Implants
The BIOPLAN Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes, insoles ...)
- Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instabilitv
The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy. The BIOPLAN Subtalar Implants are used for the correction of the flatfoot pathology. The BIOPLAN Subtalar Implants are available in Titanium alloy and PEEK options.
This document is an FDA 510(k) clearance letter and summary for a medical device (BRM Screw Family). It does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithmic performance.
The "Performance Testing" section states: "Testing included static strength and fatigue strength testing, pushout and pull-out testing, as well as insertion and extraction torque testing. Results were determined to meet the pre-defined acceptance criteria per ASTM F543 and ASTM F1264."
This refers to mechanical and material performance of the screws themselves, not the performance of an AI algorithm. Therefore, the requested information (acceptance criteria for an AI device, sample sizes, expert qualifications, MRMC studies, etc.) is not present in the provided text.
To answer your request, I would need a document describing the clinical or algorithmic performance study of a device, rather than a 510(k) clearance for a physical medical device like bone screws.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.