(133 days)
The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
Opening/Closing base wedge osteotomies, Distal and Proximal Chevron osteotomies, Ludloff Osteotomy,
Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux rigidus and/or hallux valgus, Revision MTP Fusion Revision of failed first MTP Arthroplasty implant
Metatarsal and Phalanges: Metatarsal and Phalanges fractures and osteotomies;
Mid / Hindfoot Fractures: Cuneiform Fracture, Cuboid Fracture, Navicular Fracture
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
Mid / Hindfoot Osteotomies (Deformity Corrections):
Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy
The TriMed ASET Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium and titanium alloy. Implant offerings are as followed: 1st MTP Osteotomy plates, H-Plate, Talonavicular Plate, Calcaneal Slide Osteotomy Plate, Evans Osteotomy Plate, Medial Column Fusion Plate, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and non-locking screws are also included.
This FDA 510(k) premarket notification letter concerns the TriMed ASET Foot Plating System. It does not contain information about acceptance criteria or specific studies proving a device meets them in the context of an AI/software device. Instead, it details the regulatory approval of a hardware medical device (bone fixation plates and screws).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as this document does not contain that type of data for an AI/software component.
The document states: "Clinical studies were not conducted for the subject devices." This confirms that there's no clinical performance data for this submission that would involve AI/software performance metrics.
The safety and performance of the TriMed ASET Foot Plating System were evaluated through non-clinical testing:
- Study: The implants were tested according to the recommendations in the FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff."
- Methodology: Static and dynamic four-point bending tests were conducted per ASTM F382-17.
- Specific Plate Tested: The TriMed ASET Calcaneal Sliding Osteotomy plate was specifically mentioned for static bending.
- Conclusion: The testing showed that the loading was greater or equal to the referenced predicate device. This suggests the acceptance criterion was likely non-inferiority or superiority in mechanical strength compared to the predicate device.
There is no information in the provided text regarding any AI or software component, nor any associated acceptance criteria, specific performance metrics for AI, sample sizes, ground truth, or multi-reader studies.
§ 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.